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Trial record 5 of 82 for:    GRAZOPREVIR ANHYDROUS AND ELBASVIR

An Efficacy and Safety Study of Grazoprevir (MK-5172) + Elbasvir (MK-8742) in the Treatment of Chronic Hepatitis C Virus in Participants Who Are Co-Infected With Human Immunodeficiency Virus:C-EDGE CO-INFXN (MK-5172-061)

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ClinicalTrials.gov Identifier: NCT02105662
Recruitment Status : Completed
First Posted : April 7, 2014
Results First Posted : March 4, 2016
Last Update Posted : October 3, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Chronic Hepatitis C
Intervention Drug: Grazoprevir 100 mg/Elbasvir 50 mg fixed-dose combination tablets
Enrollment 218
Recruitment Details  
Pre-assignment Details 218 participants were enrolled and treated on study, 212 participants completed 24 weeks of follow-up.
Arm/Group Title Grazoprevir+Elbasvir
Hide Arm/Group Description Participants received a fixed-dose combination (FDC) of grazoprevir 100 mg plus elbasvir 50 mg once daily for 12 weeks and were followed-up for 24 weeks.
Period Title: Overall Study
Started 218
Completed 212
Not Completed 6
Reason Not Completed
Lost to Follow-up             5
Withdrawal by Subject             1
Arm/Group Title Grazoprevir+Elbasvir
Hide Arm/Group Description Participants received a FDC of grazoprevir 100 mg plus elbasvir 50 mg once daily for 12 weeks and were followed-up for 24 weeks.
Overall Number of Baseline Participants 218
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 218 participants
48.7  (8.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 218 participants
Female
35
  16.1%
Male
183
  83.9%
1.Primary Outcome
Title Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After the End of All Study Therapy (SVR12)
Hide Description Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 (High Pure System). The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a lower limit of quantification of 15 IU/mL and a limit of detection of 9.3 IU/mL (in plasma). SVR12 was defined as undetectable (<9.3 IU/mL) HCV RNA at 12 weeks after the end of all study therapy.
Time Frame 12 weeks after end of all therapy (Study Week 24)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS); all allocated participants who received at least 1 dose of study treatment.
Arm/Group Title Grazoprevir+Elbasvir
Hide Arm/Group Description:
Participants received a FDC of grazoprevir 100 mg plus elbasvir 50 mg once daily for 12 weeks and were followed-up for 24 weeks.
Overall Number of Participants Analyzed 218
Measure Type: Number
Unit of Measure: percentage of participants
96.3
2.Primary Outcome
Title Percentage of Participants Experiencing Adverse Events (AEs) During the Treatment Period and First 14 Follow-up Days
Hide Description An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol -specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor’s product, is also an AE.
Time Frame Treatment Period plus first 14 follow-up days (up to 14 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
All Participants as Treated (APaT) Population; all participants who received at least one dose of study treatment.
Arm/Group Title Grazoprevir+Elbasvir
Hide Arm/Group Description:
Participants received a FDC of grazoprevir 100 mg plus elbasvir 50 mg once daily for 12 weeks and were followed-up for 24 weeks.
Overall Number of Participants Analyzed 218
Measure Type: Number
Unit of Measure: percentage of participants
73.9
3.Primary Outcome
Title Percentage of Participants Discontinuing Study Therapy Due to AEs During the Treatment Period
Hide Description An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol -specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor’s product, is also an AE.
Time Frame Treatment Period (up to 12 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
APaT Population; all participants who received at least one dose of study treatment.
Arm/Group Title Grazoprevir+Elbasvir
Hide Arm/Group Description:
Participants received a FDC of grazoprevir 100 mg plus elbasvir 50 mg once daily for 12 weeks and were followed-up for 24 weeks.
Overall Number of Participants Analyzed 218
Measure Type: Number
Unit of Measure: percentage of participants
0.0
4.Secondary Outcome
Title Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After the End of All Study Therapy (SVR24)
Hide Description Blood was drawn from each participant to assess HCV RNA plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 (High Pure System). The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a lower limit of quantification of 15 IU/mL and a limit of detection of 9.3 IU/mL (in plasma). SVR24 was defined as undetectable (<9.3 IU/mL) HCV RNA at 24 weeks after the end of all study therapy.
Time Frame 24 weeks after end of all therapy (Study Week 36)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; all allocated participants who received at least 1 dose of study treatment.
Arm/Group Title Grazoprevir+Elbasvir
Hide Arm/Group Description:
Participants received a FDC of grazoprevir 100 mg plus elbasvir 50 mg once daily for 12 weeks and were followed-up for 24 weeks.
Overall Number of Participants Analyzed 218
Measure Type: Number
Unit of Measure: percentage of participants
93.1
Time Frame 12 week treatment period plus 24 week follow-up period (up to 36 weeks)
Adverse Event Reporting Description APaT Population; all participants who received at least one dose of study treatment.
 
Arm/Group Title Grazoprevir + Elbasvir
Hide Arm/Group Description Participants received a FDC of grazoprevir 100 mg plus elbasvir 50 mg once daily for 12 weeks and were followed-up for 24 weeks.
All-Cause Mortality
Grazoprevir + Elbasvir
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Grazoprevir + Elbasvir
Affected / at Risk (%) # Events
Total   8/218 (3.67%)    
Infections and infestations   
Erysipelas  1  1/218 (0.46%)  1
Peritonitis bacterial  1  1/218 (0.46%)  1
Pneumonia  1  1/218 (0.46%)  1
Cellulitis  1  1/218 (0.46%)  1
Injury, poisoning and procedural complications   
Ulna fracture  1  1/218 (0.46%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Squamous cell carcinoma of the tongue  1  1/218 (0.46%)  1
Nervous system disorders   
Seizure  1  1/218 (0.46%)  1
Psychiatric disorders   
Acute psychosis  1  1/218 (0.46%)  1
Renal and urinary disorders   
Urinary retention  1  1/218 (0.46%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Grazoprevir + Elbasvir
Affected / at Risk (%) # Events
Total   106/218 (48.62%)    
Gastrointestinal disorders   
Abdominal pain upper  1  11/218 (5.05%)  11
Diarrhoea  1  18/218 (8.26%)  19
Nausea  1  20/218 (9.17%)  20
General disorders   
Fatigue  1  29/218 (13.30%)  31
Infections and infestations   
Nasopharyngitis  1  14/218 (6.42%)  14
Upper respiratory tract infection  1  17/218 (7.80%)  18
Nervous system disorders   
Headache  1  27/218 (12.39%)  33
Psychiatric disorders   
Insomnia  1  16/218 (7.34%)  16
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.0
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.
The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT02105662     History of Changes
Other Study ID Numbers: 5172-061
2014-000342-30 ( EudraCT Number )
First Submitted: April 2, 2014
First Posted: April 7, 2014
Results First Submitted: February 3, 2016
Results First Posted: March 4, 2016
Last Update Posted: October 3, 2018