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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

Tracking Information
First Submitted Date  ICMJE April 2, 2009
First Posted Date  ICMJE April 3, 2009
Results First Submitted Date  ICMJE August 6, 2015
Results First Posted Date  ICMJE October 23, 2015
Last Update Posted Date October 23, 2015
Study Start Date  ICMJE June 2009
Actual Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 23, 2015)
Percentage of Participants With Extended Rapid Virologic Response (eRVR) at Weeks 4 and 12 [ Time Frame: A Weeks 4 and 12 ]
eRVR was defined as undetectable hepatitis C virus RNA less than the lower limit of detection (10 IU/mL) at Weeks 4 and 12.
Original Primary Outcome Measures  ICMJE
 (submitted: April 2, 2009)
Antiviral activity as determined by the proportion of subjects with extended rapid virologic response (eRVR) defined as HCV RNA < 10 IU/mL at both Weeks 4 and 12 [ Time Frame: Week 4 and Week 12 ]
Change History Complete list of historical versions of study NCT00874770 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 23, 2015)
  • Percentage of Participants With Rapid Virologic Response (RVR) at Week 4 [ Time Frame: At Week 4 ]
    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.
  • Percentage of Participants With Early Virologic Response (EVR) at Week 12 [ Time Frame: At Week 12 ]
    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.
  • Percentage of Participants With a Complete Early Virologic Response (cEVR) at Week 12 [ Time Frame: At Week 12 ]
    cEVR was defined as hepatitis C virus RNA <10 IU/mL at Week 12
Original Secondary Outcome Measures  ICMJE
 (submitted: April 2, 2009)
Safety, as measured by the frequency of serious adverse events (SAEs), discontinuations due to adverse events (AEs), and Grade 3 - 4 laboratory abnormalities and, [ Time Frame: Week 4 and Week 12 ]
Current Other Pre-specified Outcome Measures
 (submitted: September 23, 2015)
  • Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Treatment-related AEs and Who Died in Treatment Phase [ 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 ]
    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.
  • 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 [ Time Frame: From Day 31 up to Week 24 of post treatment follow-up ]
    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.
  • Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results [ Time Frame: From screening up to Week 12 (treatment period) ]
    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.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Daclatasvir (BMS-790052) Plus Standard of Care (Pegylated-interferon Alpha and Ribavirin)
Official Title  ICMJE A Phase 2a Study of BMS-790052 in Combination With Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Treatment Naive Subjects With Chronic Hepatitis C Virus Genotype 1
Brief Summary The purpose of this study is to identify 1 or more doses of daclatasvir, which when used in combination with pegylated interferon alpha and ribavirin, are safe and demonstrate sufficient anti-hepatitis C virus activity.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Hepatitis C Infection
Intervention  ICMJE
  • Drug: Daclatasvir
    Tablets, oral, 3 mg, Daily, 48 weeks
  • Drug: Daclatasvir
    Tablets, oral, 10 mg, Daily, 48 weeks
  • Drug: Daclatasvir
    Tablets, oral, 60 mg, Daily, 48 weeks
  • Drug: Placebo
    Tablet, oral, 0 mg, Daily 48 weeks
  • Drug: Peginterferon alpha-2a
    Syringe, subcutaneous, 180 µg, Weekly, 48 weeks
    Other Name: Pegasys
  • Drug: ribavirin
    Tablet, oral, 1000 or 1200 mg, based on weight, Daily, 48 weeks
    Other Name: Copegus
Study Arms  ICMJE
  • Experimental: Daclatasvir, plus Peginterferon alpha-2a, ribavirin (A)
    Active Comparator
    Interventions:
    • Drug: Daclatasvir
    • Drug: Peginterferon alpha-2a
    • Drug: ribavirin
  • Experimental: Daclatasvir, Peginterferon alpha-2a, ribavirin (B)
    Active Comparator
    Interventions:
    • Drug: Daclatasvir
    • Drug: Peginterferon alpha-2a
    • Drug: ribavirin
  • Experimental: Daclatasvir, Peginterferon alpha-2a, ribavirin (C)
    Active Comparator
    Interventions:
    • Drug: Daclatasvir
    • Drug: Peginterferon alpha-2a
    • Drug: ribavirin
  • Active Comparator: Placebo, Peginterferon alpha-2a, ribavirin (D)
    Interventions:
    • Drug: Placebo
    • Drug: Peginterferon alpha-2a
    • Drug: ribavirin
Publications * Pol S, Ghalib RH, Rustgi VK, Martorell C, Everson GT, Tatum HA, Hézode C, Lim JK, Bronowicki JP, Abrams GA, Bräu N, Morris DW, Thuluvath PJ, Reindollar RW, Yin PD, Diva U, Hindes R, McPhee F, Hernandez D, Wind-Rotolo M, Hughes EA, Schnittman S. Daclatasvir for previously untreated chronic hepatitis C genotype-1 infection: a randomised, parallel-group, double-blind, placebo-controlled, dose-finding, phase 2a trial. Lancet Infect Dis. 2012 Sep;12(9):671-7. doi: 10.1016/S1473-3099(12)70138-X. Epub 2012 Jun 18.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 23, 2015)
74
Original Estimated Enrollment  ICMJE
 (submitted: April 2, 2009)
48
Actual Study Completion Date  ICMJE January 2011
Actual Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  • Patients chronically infected with hepatitis C virus (HCV) genotype 1
  • HCV RNA viral load of ≥10*5* IU/mL (100,000 IU/mL) at screening
  • Treatment naive

Key Exclusion Criteria:

  • Women of child-bearing potential
  • Cirrhosis
  • Coinfection with HIV or hepatitis B virus
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   United States
Removed Location Countries Argentina
 
Administrative Information
NCT Number  ICMJE NCT00874770
Other Study ID Numbers  ICMJE AI444-014
EUDRACT# 2009-010149-29
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP