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Safety and Efficacy of Daclatasvir (BMS-790052) Plus Standard of Care (Pegylated-interferon Alpha and Ribavirin)

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ClinicalTrials.gov Identifier: NCT00874770
Recruitment Status : Completed
First Posted : April 3, 2009
Results First Posted : October 23, 2015
Last Update Posted : October 23, 2015
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Hepatitis C Infection
Interventions Drug: Daclatasvir
Drug: Placebo
Drug: Peginterferon alpha-2a
Drug: ribavirin
Enrollment 74
Recruitment Details The study was conducted at 14 sites in France and USA.
Pre-assignment Details A total of 74 participants were enrolled, of which 48 were randomized to receive treatment and 26 were not randomized: 22 no longer met study criteria, 2 withdrew consent, 1 was lost to follow-up, and 1 due to other reasons.
Arm/Group Title Daclatasvir 3 mg + pegIFNα-2a + Ribavirin Daclatasvir 10 mg + pegIFNα-2a + Ribavirin Daclatasvir 60 mg + pegIFNα-2a + Ribavirin Placebo+pegIFNα-2a+Ribavirin
Hide Arm/Group Description Participants received 3 mg of daclatasvir once daily (OD) in coadministration with peginterferon alpha-2a (pegIFNα-2a)180 µg administered subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks). Participants received 10 mg of daclatasvir OD coadministered with pegIFNα-2a 180 µg given subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks). Participants received 60 mg of daclatasvir OD in coadministration with pegIFNα-2a 180 µg administered subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks). Participants received a matching placebo of daclatasvir tablets administered orally once daily for 48 weeks in coadministration with pegIFNα-2a 180 µg administered subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
Period Title: Overall Study
Started 12 12 12 12
Completed 7 11 8 7
Not Completed 5 1 4 5
Reason Not Completed
Lack of Efficacy             2             0             0             2
Adverse Event             1             1             4             2
Lost to Follow-up             1             0             0             1
Subject no Longer Meets Study Criteria             1             0             0             0
Arm/Group Title Daclatasvir 3-mg+pegIFNα-2a-2a+Ribavirin Daclatasvir 10-mg+pegIFNα-2a+Ribavirin Daclatasvir 60-mg+pegIFNα-2a+Ribavirin Placebo+pegIFNα-2a+Ribavirin Total
Hide Arm/Group Description Participants received 3 mg of daclatasvir once daily (OD) in coadministration with peginterferon alpha-2a (pegIFNα-2a)180 µg administered subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks). Participants received 10-mg of daclatasvir OD in coadministration with pegIFNα-2a-2a 180 µg administered subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks). Participants received 60-mg of daclatasvir OD in coadministration with pegIFNα-2a 180 µg administered subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks). Participants received a matching placebo of daclatasvir tablets administered orally once daily for 48 weeks in coadministration with pegIFNα-2a 180 µg administered subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks). Total of all reporting groups
Overall Number of Baseline Participants 12 12 12 12 48
Hide Baseline Analysis Population Description
The analysis was performed in the treated population defined as all participants who received at least 1 dose of study therapy.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 12 participants 12 participants 12 participants 48 participants
52  (8.56) 53.2  (9.11) 52  (7.34) 48  (10.20) 51.3  (8.80)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 12 participants 12 participants 48 participants
Female
3
  25.0%
4
  33.3%
5
  41.7%
4
  33.3%
16
  33.3%
Male
9
  75.0%
8
  66.7%
7
  58.3%
8
  66.7%
32
  66.7%
1.Primary Outcome
Title Percentage of Participants With Extended Rapid Virologic Response (eRVR) at Weeks 4 and 12
Hide Description eRVR was defined as undetectable hepatitis C virus RNA less than the lower limit of detection (10 IU/mL) at Weeks 4 and 12.
Time Frame A Weeks 4 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study drug.
Arm/Group Title Daclatasvir 3 mg + pegIFNα-2a + Ribavirin Daclatasvir 10 mg + pegIFNα-2a + Ribavirin Daclatasvir 60 mg + pegIFNα-2a + Ribavirin Placebo + pegIFNα-2a + Ribavirin
Hide Arm/Group Description:
Participants received 3 mg of daclatasvir once daily (OD) coadministered orally with peginterferon alpha-2a (pegIFNα-2a)180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
Participants received 10 mg of daclatasvir OD coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
Participants received 60 mg of daclatasvir OD in coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
Participants received a matching placebo of daclatasvir tablets coadministered orally once daily for 48 weeks with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
Overall Number of Participants Analyzed 12 12 12 12
Measure Type: Number
Unit of Measure: percentage of participants
41.7 83.3 75 8.3
2.Secondary Outcome
Title Percentage of Participants With Rapid Virologic Response (RVR) at Week 4
Hide Description RVR was defined as undetectable hepatitis C virus (HCV) RNA ie, HCV RNA less than the lower limit of detection (10 IU/mL) at Week 4.
Time Frame At Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study drug.
Arm/Group Title Daclatasvir 3 mg + pegIFNα-2a + Ribavirin Daclatasvir 10 mg + pegIFNα-2a + Ribavirin Daclatasvir 60 mg + pegIFNα-2a + Ribavirin Placebo + pegIFNα-2a + Ribavirin
Hide Arm/Group Description:
Participants received 3 mg of daclatasvir once daily (OD) coadministered orally with peginterferon alpha-2a (pegIFNα-2a)180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
Participants received 10-mg of daclatasvir OD coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
Participants received 60 mg of daclatasvir OD coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
Participants received a matching placebo of daclatasvir tablets coadministered orally once daily for 48 weekswith pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
Overall Number of Participants Analyzed 12 12 12 12
Measure Type: Number
Unit of Measure: percentage of participants
41.7 91.7 83.3 8.3
3.Secondary Outcome
Title Percentage of Participants With Early Virologic Response (EVR) at Week 12
Hide Description EVR was defined as a ≥2 log10 decrease in hepatitis C virus (HCV) RNA from baseline at Week 12 , or HCV RNA <10 IU/mL for participants with baseline HCV RNA <1000 IU/mL.
Time Frame At Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study drug.
Arm/Group Title Daclatasvir 3 mg + pegIFNα-2a + Ribavirin Daclatasvir 10 mg + pegIFNα-2a + Ribavirin Daclatasvir 60 mg + pegIFNα-2a + Ribavirin Placebo + pegIFNα-2a + Ribavirin
Hide Arm/Group Description:
Participants received 3 mg of daclatasvir once daily (OD) coadministered orally with peginterferon alpha-2a (pegIFNα-2a)180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
Participants received 10 mg of daclatasvir OD in coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
Participants received 60 mg of daclatasvir OD coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
Participants received a matching placebo of daclatasvir tablets coadministered orally once daily for 48 weeks with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
Overall Number of Participants Analyzed 12 12 12 12
Measure Type: Number
Unit of Measure: percentage of participants
75 100 83.3 66.7
4.Secondary Outcome
Title Percentage of Participants With a Complete Early Virologic Response (cEVR) at Week 12
Hide Description cEVR was defined as hepatitis C virus RNA <10 IU/mL at Week 12
Time Frame At Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study drug.
Arm/Group Title Daclatasvir 3 mg + pegIFNα-2a + Riibavirin Daclatasvir 10 mg + pegIFNα-2a + Ribavirin Daclatasvir 60 mg + pegIFNα-2a + Ribavirin Placebo + pegIFNα-2a + Ribavirin
Hide Arm/Group Description:
Participants received 3 mg of daclatasvir once daily (OD) coadministered orally with peginterferon alpha-2a (pegIFNα-2a)180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
Participants received 10 mg of daclatasvir OD coadministered orally with pegIFNα-2a 180 µg administered subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
Participants received 60 mg of daclatasvir OD coadministered orally with pegIFNα-2a 180 µg administered subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
Participants received a matching placebo of daclatasvir tablets coadministered orally once daily for 48 weeks with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).48 weeks.
Overall Number of Participants Analyzed 12 12 12 12
Measure Type: Number
Unit of Measure: percentage of participants
58.3 83.3 83.3 41.7
5.Other Pre-specified Outcome
Title Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Treatment-related AEs and Who Died in Treatment Phase
Hide Description An AE was defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a patient or clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. Treatment-related AE was defined as an AE that had certain, probable, possible, or unknown relationship to study drug.
Time Frame SAE: From Day 1 up to 30 days after last dose of study drug, AE: From Day 1 to 7 days after last dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study drug.
Arm/Group Title Daclatasvir 3 mg + pegIFNα-2a + Ribavirin Daclatasvir 10 mg + pegIFNα-2a + Ribavirin Daclatasvir 60 mg + pegIFNα-2a + Ribavirin Placebo + pegIFNα-2a + Ribavirin
Hide Arm/Group Description:
Participants received 3 mg of daclatasvir once daily (OD) coadministered orally with peginterferon alpha-2a (pegIFNα-2a)180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
Participants received 10 mg of daclatasvir OD coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
Participants received 60 mg of daclatasvir OD coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
Participants received a matching placebo of daclatasvir tablets coadministered orally once daily for 48 weeks with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
Overall Number of Participants Analyzed 12 12 12 12
Measure Type: Number
Unit of Measure: participants
SAEs 1 1 1 0
Discontinuation due to AEs 1 1 4 2
Grade 2 to 4 Related AEs 6 6 9 7
Deaths 0 0 0 0
6.Other Pre-specified Outcome
Title Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Treatment-related AEs and Who Died in Follow-up Period
Hide Description An AE was defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a patient or clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. Treatment-related AE was defined as an AE that had certain, probable, possible, or unknown relationship to study drug.
Time Frame From Day 31 up to Week 24 of post treatment follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study drug. n=evaluable patients
Arm/Group Title Daclatasvir 3 mg + pegIFNα-2a + Rribavirin Daclatasvir 10 mg + pegIFNα-2a + Ribavirin Daclatasvir 60 mg + pegIFNα-2a + Ribavirin Placebo + pegIFNα-2a + Ribavirin
Hide Arm/Group Description:
Participants received 3 mg of daclatasvir once daily (OD) coadministered orally with peginterferon alpha-2a (pegIFNα-2a)180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
Participants received 10 mg of daclatasvir OD coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
Participants received 60 mg of daclatasvir OD coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
Participants received a matching placebo of daclatasvir tablets coadministered orally once daily for 48 weeks with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
Overall Number of Participants Analyzed 12 12 12 12
Measure Type: Number
Unit of Measure: participants
SAEs (n=10,12,12,10) 0 0 3 0
Discontinuation due to AEs 0 0 0 0
Grade 2 to 4 Related AEs 0 0 0 0
Deaths 0 0 0 0
7.Other Pre-specified Outcome
Title Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results
Hide Description Clinically significant change in marked laboratory abnormalities (Grade 3 to 4 ) included: Alanine aminotransferase (ALT)- Grade 3 as >5.0 to 10.0* Upper Limit of Normal (ULN), Grade 4 as >10.0*ULN; Aspartate aminotransferase (AST)- Grade 3 as >5.0 to 10.0*ULN, Grade 4 as >10.0*ULN; Hemoglobin- Grade 3 as 7.0 to 8.9 g/dL, Grade 4 as <7.0 g/dL; Neutrophils- Grade 3 as 0.5 to 0.749*10^9/L, Grade 4 as <0.5*10^9/L; Lymphocytes- Grade 3 as 0.35 to 0.499*10^9/L, Grade 4 as <0.35*10^9/L; Total Bilirubin- Grade 3 as 2.6-5.0*ULN, Grade 4 as >5.0*ULN; Platelets- Grade 3 as 25000 to 49999*10^9/L, Grade 4 as <25000 10^9/L and white blood cells (WBC) - Grade 3 as 1000 to 1499*10^9/L, Grade 4 as <1000*10^9/L.
Time Frame From screening up to Week 12 (treatment period)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study drug. n=evaluable patients at the specified time point
Arm/Group Title Daclatasvir 3 mg + pegIFNα-2a + Ribavirin Daclatasvir 10 mg + pegIFNα-2a + Ribavirin Daclatasvir 60 mg + pegIFNα-2a + Ribavirin Placebo + pegIFNα-2a + Ribavirin
Hide Arm/Group Description:
Participants received 3 mg of daclatasvir once daily (OD) coadministered orally with peginterferon alpha-2a (pegIFNα-2a)180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
Participants received 10 mg of daclatasvir OD coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
Participants received 60 mg of daclatasvir OD coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
Participants received a matching placebo of daclatasvir tablets once daily for 48 weeks coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
Overall Number of Participants Analyzed 12 12 12 12
Measure Type: Number
Unit of Measure: participants
Hemoglobin (n= 11,12,12,11) 1 0 1 0
Lymphocytes (n= 11,12,12,12) 1 3 3 3
Neutrophils (n= 11,12,12,12) 2 4 3 4
Platelets (n= 11,12,12,12) 0 0 0 1
ALT (n= 11,12,12,12) 0 1 0 3
AST (n= 11,12,12,12) 0 0 0 3
Total bilirubin (n= 11,12,12,12) 0 0 1 0
WBC (n= 11, 12, 12, 12) 0 2 1 2
Time Frame From baseline to 30 days after last dose of drug
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Daclatasvir 3 mg + pegIFNα-2a + Ribavirin Daclatasvir 10 mg + pegIFNα-2a + Ribavirin Daclatasvir 60 mg + pegIFNα-2a + Ribavirin Placebo + pegIFNα-2a + Ribavirin
Hide Arm/Group Description Participants received 3 mg of daclatasvir once daily (OD) in coadministration orally with peginterferon alpha-2a (pegIFNα-2a)180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks). Participants received 10 mg of daclatasvir OD in coadministration orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks). Participants received 60 mg of daclatasvir OD in coadministration orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks). Participants received a matching placebo of daclatasvir tablets coadministered orally once daily for 48 weeks in with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
All-Cause Mortality
Daclatasvir 3 mg + pegIFNα-2a + Ribavirin Daclatasvir 10 mg + pegIFNα-2a + Ribavirin Daclatasvir 60 mg + pegIFNα-2a + Ribavirin Placebo + pegIFNα-2a + Ribavirin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Daclatasvir 3 mg + pegIFNα-2a + Ribavirin Daclatasvir 10 mg + pegIFNα-2a + Ribavirin Daclatasvir 60 mg + pegIFNα-2a + Ribavirin Placebo + pegIFNα-2a + Ribavirin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/12 (8.33%)   1/12 (8.33%)   1/12 (8.33%)   0/12 (0.00%) 
Blood and lymphatic system disorders         
Anaemia † 1  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%) 
General disorders         
Chest pain † 1  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%) 
Infections and infestations         
Bronchitis † 1  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%) 
Nervous system disorders         
Syncope † 1  1/12 (8.33%)  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Epistaxis † 1  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Daclatasvir 3 mg + pegIFNα-2a + Ribavirin Daclatasvir 10 mg + pegIFNα-2a + Ribavirin Daclatasvir 60 mg + pegIFNα-2a + Ribavirin Placebo + pegIFNα-2a + Ribavirin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   12/12 (100.00%)   12/12 (100.00%)   12/12 (100.00%)   12/12 (100.00%) 
Blood and lymphatic system disorders         
Lymphadenopathy † 1  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%) 
Thrombocytopenia † 1  0/12 (0.00%)  1/12 (8.33%)  1/12 (8.33%)  1/12 (8.33%) 
Neutropenia † 1  4/12 (33.33%)  3/12 (25.00%)  2/12 (16.67%)  5/12 (41.67%) 
Anaemia † 1  5/12 (41.67%)  3/12 (25.00%)  6/12 (50.00%)  5/12 (41.67%) 
Lymphopenia † 1  0/12 (0.00%)  0/12 (0.00%)  2/12 (16.67%)  0/12 (0.00%) 
Cardiac disorders         
Tachycardia † 1  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%) 
Ear and labyrinth disorders         
Vertigo † 1  0/12 (0.00%)  1/12 (8.33%)  1/12 (8.33%)  0/12 (0.00%) 
Eye disorders         
Ocular hyperaemia † 1  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%) 
Vision blurred † 1  2/12 (16.67%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%) 
Dry eye † 1  1/12 (8.33%)  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%) 
Gastrointestinal disorders         
Abdominal pain upper † 1  0/12 (0.00%)  1/12 (8.33%)  1/12 (8.33%)  1/12 (8.33%) 
Dry mouth † 1  0/12 (0.00%)  2/12 (16.67%)  1/12 (8.33%)  1/12 (8.33%) 
Gingival pain † 1  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%) 
Abdominal tenderness † 1  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%) 
Dyspepsia † 1  1/12 (8.33%)  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%) 
Proctalgia † 1  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%) 
Abdominal pain † 1  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%) 
Cheilitis † 1  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%) 
Gastrooesophageal reflux disease † 1  3/12 (25.00%)  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%) 
Hyperchlorhydria † 1  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%) 
Vomiting † 1  1/12 (8.33%)  2/12 (16.67%)  4/12 (33.33%)  0/12 (0.00%) 
Flatulence † 1  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%) 
Periodontal disease † 1  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%) 
Stomatitis † 1  1/12 (8.33%)  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%) 
Gingival disorder † 1  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%) 
Abdominal pain lower † 1  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%) 
Tongue ulceration † 1  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%) 
Dental caries † 1  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%) 
Diarrhoea † 1  1/12 (8.33%)  3/12 (25.00%)  1/12 (8.33%)  3/12 (25.00%) 
Gingival hypertrophy † 1  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%) 
Nausea † 1  4/12 (33.33%)  5/12 (41.67%)  4/12 (33.33%)  6/12 (50.00%) 
General disorders         
Injection site reaction † 1  1/12 (8.33%)  1/12 (8.33%)  0/12 (0.00%)  1/12 (8.33%) 
Injection site erythema † 1  0/12 (0.00%)  1/12 (8.33%)  1/12 (8.33%)  0/12 (0.00%) 
Irritability † 1  3/12 (25.00%)  6/12 (50.00%)  3/12 (25.00%)  2/12 (16.67%) 
Asthenia † 1  3/12 (25.00%)  1/12 (8.33%)  5/12 (41.67%)  1/12 (8.33%) 
Injection site pain † 1  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%) 
Fatigue † 1  6/12 (50.00%)  7/12 (58.33%)  6/12 (50.00%)  9/12 (75.00%) 
Influenza like illness † 1  3/12 (25.00%)  6/12 (50.00%)  2/12 (16.67%)  4/12 (33.33%) 
Injection site irritation † 1  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%) 
Malaise † 1  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%) 
Chills † 1  2/12 (16.67%)  1/12 (8.33%)  1/12 (8.33%)  2/12 (16.67%) 
Injection site pruritus † 1  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%) 
Pyrexia † 1  1/12 (8.33%)  3/12 (25.00%)  3/12 (25.00%)  3/12 (25.00%) 
Chest pain † 1  0/12 (0.00%)  1/12 (8.33%)  1/12 (8.33%)  0/12 (0.00%) 
Pain † 1  3/12 (25.00%)  0/12 (0.00%)  2/12 (16.67%)  1/12 (8.33%) 
Hepatobiliary disorders         
Hypertransaminasaemia † 1  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%) 
Infections and infestations         
Ear infection † 1  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%) 
Genital herpes † 1  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%) 
Carbuncle † 1  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%) 
Oral herpes † 1  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%) 
Upper respiratory tract infection † 1  2/12 (16.67%)  0/12 (0.00%)  1/12 (8.33%)  1/12 (8.33%) 
Gastroenteritis † 1  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%) 
Hordeolum † 1  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%) 
Nasopharyngitis † 1  0/12 (0.00%)  1/12 (8.33%)  1/12 (8.33%)  0/12 (0.00%) 
Oral candidiasis † 1  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%) 
Gastrointestinal viral infection † 1  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%) 
Herpes zoster † 1  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%) 
Pharyngitis † 1  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%) 
Tooth infection † 1  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%) 
Body tinea † 1  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%) 
Gastroenteritis viral † 1  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%) 
Pneumonia † 1  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%) 
Influenza † 1  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%) 
Tooth abscess † 1  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%) 
Bronchitis † 1  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%)  2/12 (16.67%) 
Osteomyelitis † 1  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%) 
Sinusitis † 1  0/12 (0.00%)  1/12 (8.33%)  2/12 (16.67%)  0/12 (0.00%) 
Wound infection † 1  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%) 
Injury, poisoning and procedural complications         
Muscle strain † 1  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%) 
Road traffic accident † 1  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%) 
Arthropod bite † 1  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%) 
Tooth fracture † 1  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%) 
Lip injury † 1  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%) 
Investigations         
Blood thyroid stimulating hormone increased † 1  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%) 
Weight decreased † 1  3/12 (25.00%)  1/12 (8.33%)  0/12 (0.00%)  2/12 (16.67%) 
Liver function test abnormal † 1  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%) 
Electrocardiogram QT prolonged † 1  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%) 
Prothrombin time prolonged † 1  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%) 
Weight increased † 1  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%) 
Metabolism and nutrition disorders         
Decreased appetite † 1  2/12 (16.67%)  3/12 (25.00%)  4/12 (33.33%)  3/12 (25.00%) 
Musculoskeletal and connective tissue disorders         
Back pain † 1  0/12 (0.00%)  2/12 (16.67%)  1/12 (8.33%)  2/12 (16.67%) 
Muscular weakness † 1  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%) 
Arthralgia † 1  1/12 (8.33%)  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%) 
Muscle spasms † 1  0/12 (0.00%)  0/12 (0.00%)  2/12 (16.67%)  0/12 (0.00%) 
Myalgia † 1  3/12 (25.00%)  3/12 (25.00%)  2/12 (16.67%)  3/12 (25.00%) 
Pain in extremity † 1  1/12 (8.33%)  2/12 (16.67%)  0/12 (0.00%)  0/12 (0.00%) 
Musculoskeletal chest pain † 1  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%) 
Coccydynia † 1  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%) 
Musculoskeletal pain † 1  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%) 
Nervous system disorders         
Dysgeusia † 1  1/12 (8.33%)  1/12 (8.33%)  0/12 (0.00%)  1/12 (8.33%) 
Cubital tunnel syndrome † 1  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%) 
Disturbance in attention † 1  0/12 (0.00%)  1/12 (8.33%)  1/12 (8.33%)  0/12 (0.00%) 
Tremor † 1  2/12 (16.67%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%) 
Dizziness † 1  2/12 (16.67%)  1/12 (8.33%)  2/12 (16.67%)  1/12 (8.33%) 
Presyncope † 1  1/12 (8.33%)  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%) 
Syncope † 1  1/12 (8.33%)  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%) 
Burning sensation † 1  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%) 
Paraesthesia † 1  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%) 
Headache † 1  9/12 (75.00%)  7/12 (58.33%)  3/12 (25.00%)  3/12 (25.00%) 
Hyperaesthesia † 1  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%) 
Poor quality sleep † 1  1/12 (8.33%)  0/12 (0.00%)  1/12 (8.33%)  1/12 (8.33%) 
Ageusia † 1  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%) 
Dizziness postural † 1  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%) 
Hypoaesthesia † 1  0/12 (0.00%)  2/12 (16.67%)  1/12 (8.33%)  0/12 (0.00%) 
Sinus headache † 1  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%) 
Psychiatric disorders         
Abnormal dreams † 1  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%) 
Food aversion † 1  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%) 
Hallucination, auditory † 1  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%) 
Libido decreased † 1  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  1/12 (8.33%) 
Agitation † 1  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%) 
Depressed mood † 1  1/12 (8.33%)  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%) 
Depression † 1  2/12 (16.67%)  3/12 (25.00%)  2/12 (16.67%)  3/12 (25.00%) 
Insomnia † 1  4/12 (33.33%)  4/12 (33.33%)  5/12 (41.67%)  6/12 (50.00%) 
Anxiety † 1  1/12 (8.33%)  3/12 (25.00%)  2/12 (16.67%)  2/12 (16.67%) 
Mood swings † 1  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%)  1/12 (8.33%) 
Sleep disorder † 1  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%)  1/12 (8.33%) 
Renal and urinary disorders         
Dysuria † 1  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%) 
Micturition urgency † 1  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%) 
Reproductive system and breast disorders         
Erectile dysfunction † 1  0/12 (0.00%)  0/12 (0.00%)  2/12 (16.67%)  0/12 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Dysphonia † 1  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%) 
Dyspnoea exertional † 1  1/12 (8.33%)  1/12 (8.33%)  1/12 (8.33%)  0/12 (0.00%) 
Sinus congestion † 1  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%) 
Epistaxis † 1  1/12 (8.33%)  2/12 (16.67%)  0/12 (0.00%)  0/12 (0.00%) 
Dyspnoea † 1  2/12 (16.67%)  1/12 (8.33%)  3/12 (25.00%)  2/12 (16.67%) 
Nasal congestion † 1  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%) 
Bronchitis chronic † 1  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%) 
Respiratory tract congestion † 1  0/12 (0.00%)  1/12 (8.33%)  1/12 (8.33%)  0/12 (0.00%) 
Wheezing † 1  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%) 
Cough † 1  5/12 (41.67%)  2/12 (16.67%)  2/12 (16.67%)  3/12 (25.00%) 
Oropharyngeal pain † 1  1/12 (8.33%)  2/12 (16.67%)  1/12 (8.33%)  0/12 (0.00%) 
Rhinorrhoea † 1  1/12 (8.33%)  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%) 
Skin and subcutaneous tissue disorders         
Rash macular † 1  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%) 
Toxic skin eruption † 1  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%) 
Actinic keratosis † 1  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%) 
Pain of skin † 1  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%) 
Dry skin † 1  1/12 (8.33%)  0/12 (0.00%)  1/12 (8.33%)  1/12 (8.33%) 
Eczema † 1  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%) 
Hyperhidrosis † 1  2/12 (16.67%)  2/12 (16.67%)  0/12 (0.00%)  1/12 (8.33%) 
Pruritus † 1  5/12 (41.67%)  3/12 (25.00%)  4/12 (33.33%)  3/12 (25.00%) 
Skin atrophy † 1  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%) 
Dermatitis contact † 1  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%) 
Dermatitis exfoliative † 1  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%) 
Psoriasis † 1  1/12 (8.33%)  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%) 
Skin lesion † 1  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%) 
Erythema † 1  1/12 (8.33%)  0/12 (0.00%)  2/12 (16.67%)  0/12 (0.00%) 
Rash † 1  4/12 (33.33%)  4/12 (33.33%)  2/12 (16.67%)  3/12 (25.00%) 
Rash maculo-papular † 1  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%) 
Skin irritation † 1  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%) 
Night sweats † 1  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%) 
Xeroderma † 1  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%) 
Alopecia † 1  4/12 (33.33%)  1/12 (8.33%)  3/12 (25.00%)  2/12 (16.67%) 
Rash generalised † 1  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%) 
Skin fissures † 1  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%) 
Vascular disorders         
Blood pressure fluctuation † 1  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%) 
Flushing † 1  0/12 (0.00%)  1/12 (8.33%)  1/12 (8.33%)  0/12 (0.00%) 
Arteriosclerosis † 1  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%) 
Pallor † 1  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.1
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Bristol Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single center publications until after disclosure of the clinical trial's primary publication.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: BristolMyers Squibb Study Director
Organization: Bristol-Myers Squibb International Corporation
EMail: clinical.trials@bms.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00874770     History of Changes
Other Study ID Numbers: AI444-014
EUDRACT# 2009-010149-29
First Submitted: April 2, 2009
First Posted: April 3, 2009
Results First Submitted: August 6, 2015
Results First Posted: October 23, 2015
Last Update Posted: October 23, 2015