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An Efficacy and Safety Study of Grazoprevir (MK-5172) + Elbasvir (MK-8742) in the Treatment of Chronic Hepatitis C Virus (HCV) Genotype (GT)1, 4, or 6 Infection in Treatment-Naïve Participants Who Are on Opiate Substitution Therapy (MK-5172-062) (C-EDGE CO-STAR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02105688
Recruitment Status : Completed
First Posted : April 7, 2014
Results First Posted : July 11, 2016
Last Update Posted : December 5, 2019
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Chronic Hepatitis C
Interventions Drug: Grazoprevir 100 mg/Elbasvir 50 mg FDC tablet (MK-5172A)
Drug: Placebo to Grazoprevir 100 mg/Elbasvir 50 mg FDC tablet
Enrollment 301
Recruitment Details  
Pre-assignment Details 301 participants were randomized to either the Immediate Treatment Arm or to the Deferred Treatment Arm during Part A. 199 participants who completed Part A were enrolled in Part B; of these, 142 participants completed the study.
Arm/Group Title Immediate Treatment Arm: Grazoprevir/Elbasvir Deferred Treatment Arm: Placebo > Grazoprevir/Elbasvir
Hide Arm/Group Description In Part A, participants received grazoprevir 100 mg plus elbasvir 50 mg FDC (MK-5172A) once daily for 12 weeks (blinded) and were followed-up for 24 weeks. In Part B, participants could enroll in a 3-year follow-up period where they were followed every 6 months for 3 years in an observational cohort (no treatment was administered during Part B). In Part A, participants received placebo to MK-5172A once daily for 12 weeks (blinded), followed by 4 weeks of follow-up. Afterwards, participants received 12 weeks of open-label treatment with the MK-5172A FDC and were followed-up for 24 weeks. In Part B, participants could enroll in a 3-year follow-up period where they were followed every 6 months for 3 years in an observational cohort (no treatment was administered during Part B).
Period Title: Part A: Double-Blind
Started 201 100
Completed 181 [1] 83 [1]
Not Completed 20 17
Reason Not Completed
Adverse Event             1             0
Death             0             1
Lost to Follow-up             15             11
Physician Decision             0             1
Status Unknown             0             2
Withdrawal by Subject             4             2
[1]
Completed Part A
Period Title: Part B: Observational Follow-up
Started 131 [1] 68 [1]
Completed 94 [2] 48 [2]
Not Completed 37 20
Reason Not Completed
Death             2             1
Lost to Follow-up             23             15
Withdrawal by Subject             9             3
Physician Decision             3             1
[1]
Completed Part A and met Part B Extension criteria
[2]
Completed Part B extension
Arm/Group Title Immediate Treatment Arm: Grazoprevir/Elbasvir Deferred Treatment Arm: Placebo > Grazoprevir/Elbasvir Total
Hide Arm/Group Description In Part A, participants received grazoprevir 100 mg plus elbasvir 50 mg FDC (MK-5172A) once daily for 12 weeks (blinded) and were followed-up for 24 weeks. In Part B, participants could enroll in a 3-year follow-up period where they were followed every 6 months for 3 years in an observational cohort (no treatment was administered during Part B). In Part A, participants received placebo to MK-5172A once daily for 12 weeks (blinded), followed by 4 weeks of follow-up. Afterwards, participants received 12 weeks of open-label treatment with the MK-5172A FDC and were followed-up for 24 weeks. In Part B, participants could enroll in a 3-year follow-up period where they were followed every 6 months for 3 years in an observational cohort (no treatment was administered during Part B). Total of all reporting groups
Overall Number of Baseline Participants 201 100 301
Hide Baseline Analysis Population Description
Baseline (BL) characteristics were reported for the Full Analysis Set (FAS): all randomized participants receiving ≥1 dose of study treatment.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 201 participants 100 participants 301 participants
47.4  (9.9) 46.4  (9.9) 47.1  (9.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 201 participants 100 participants 301 participants
Female
48
  23.9%
23
  23.0%
71
  23.6%
Male
153
  76.1%
77
  77.0%
230
  76.4%
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® AmpliPrep/COBAS® Taqman HCV Test, v2.0, which had a lower limit of quantification of 15 IU/mL. SVR12 was defined as HCV RNA below the lower limit of detection (<LLOQ) at 12 weeks after the end of all study therapy for baseline infection, or HCV RNA≥ LLOQ demonstrated to be due to reinfection (after clearance of baseline infection). The Clopper-Pearson method was used to construct 95% confidence intervals for the SVR12 rate. The primary efficacy analysis for Part A was the percentage of participants in the immediate treatment arm (ITA) who achieved SVR12. SVR12 was also calculated for the Deferred Treatment Arm.
Time Frame 12 weeks after end of all therapy (Study Week 24 for Immediate Treatment Arm and Study Week 40 for Deferred Treatment Arm)
Hide Outcome Measure Data
Hide Analysis Population Description
Modified FAS (mFAS): All randomized participants receiving ≥1 dose of active study treatment and excluding participants for study discontinuation for reasons unrelated to treatment regimen, response to HCV treatment, or BL genotype (GT)2, GT3, or GT5. The primary efficacy hypothesis was evaluated within participants of the Immediate Treatment Arm.
Arm/Group Title Immediate Treatment Arm: Grazoprevir/Elbasvir Deferred Treatment Arm: Placebo > Grazoprevir/Elbasvir
Hide Arm/Group Description:
In Part A, participants received grazoprevir 100 mg plus elbasvir 50 mg FDC (MK-5172A) once daily for 12 weeks (blinded) and were followed-up for 24 weeks. In Part B, participants could enroll in a 3-year follow-up period where they were followed every 6 months for 3 years in an observational cohort (no treatment was administered during Part B).
In Part A, participants received placebo to MK-5172A once daily for 12 weeks (blinded), followed by 4 weeks of follow-up. Afterwards, participants received 12 weeks of open-label treatment with the MK-5172A FDC and were followed-up for 24 weeks. In Part B, participants could enroll in a 3-year follow-up period where they were followed every 6 months for 3 years in an observational cohort (no treatment was administered during Part B).
Overall Number of Participants Analyzed 198 88
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
95.5
(91.5 to 97.9)
96.6
(90.4 to 99.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Immediate Treatment Arm: Grazoprevir/Elbasvir
Comments A one-sided exact test was used to test the null hypothesis, which was that the SVR12 rate for the ITA was less than 67% (historical reference rate derived from NCT01667731). The p-value was based on a one-sided exact test for a binomial proportion. A one-sided p-value <0.025 supports a conclusion that the true SVR12 is >67%.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method One-sided exact test
Comments [Not Specified]
2.Primary Outcome
Title Percentage of Participants Experiencing at Least One Adverse Event (AE) During the Double-Blind (DB) Treatment Period and First 14 Follow-up Days
Hide Description An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, 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 of a pre-existing condition that was temporally associated with the use of the Sponsor's product, was also an AE. For this outcome measure, the primary safety analysis compared the percentage of participants experiencing an AE in the Immediate Treatment Arm during the double-blinded active treatment period to that of the Deferred Treatment Arm during the double-blinded placebo treatment period.
Time Frame DB Treatment period plus first 14 follow-up days (up to Study Week 14)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study treatment during the Part A DB period.
Arm/Group Title Immediate Treatment Arm: Grazoprevir/Elbasvir Deferred Treatment Arm: Placebo > Grazoprevir/Elbasvir
Hide Arm/Group Description:
In Part A, participants received grazoprevir 100 mg plus elbasvir 50 mg FDC (MK-5172A) once daily for 12 weeks (blinded) and were followed-up for 24 weeks. In Part B, participants could enroll in a 3-year follow-up period where they were followed every 6 months for 3 years in an observational cohort (no treatment was administered during Part B).
In Part A, participants received placebo to MK-5172A once daily for 12 weeks (blinded), followed by 4 weeks of follow-up. Afterwards, participants received 12 weeks of open-label treatment with the MK-5172A FDC and were followed-up for 24 weeks. In Part B, participants could enroll in a 3-year follow-up period where they were followed every 6 months for 3 years in an observational cohort (no treatment was administered during Part B).
Overall Number of Participants Analyzed 201 100
Measure Type: Number
Unit of Measure: Percentage of Participants
83.1 83.0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Immediate Treatment Arm: Grazoprevir/Elbasvir, Deferred Treatment Arm: Placebo > Grazoprevir/Elbasvir
Comments Categorical AE parameters were assessed via point estimates with 95% confidence intervals provided for between-treatment differences in the percentage of participants with events using the Miettinen and Nurminen method, an unconditional, asymptotic method.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 0.2
Confidence Interval (2-Sided) 95%
-8.3 to 10.0
Estimation Comments [Not Specified]
3.Primary Outcome
Title Percentage of Participants Discontinued From Study Therapy Due to AEs During the DB Treatment Period
Hide Description An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, 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 of a pre-existing condition that was temporally associated with the use of the Sponsor's product, was also an AE. For this outcome measure, the primary safety analysis compared the percentage of participants discontinuing study therapy due to an AE in the Immediate Treatment Arm during the double-blinded active treatment period to that of the Deferred Treatment Arm during the double-blinded placebo treatment period.
Time Frame DB Treatment period (up to Study Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study treatment during the Part A DB period.
Arm/Group Title Immediate Treatment Arm: Grazoprevir/Elbasvir Deferred Treatment Arm: Placebo > Grazoprevir/Elbasvir
Hide Arm/Group Description:
In Part A, participants received grazoprevir 100 mg plus elbasvir 50 mg FDC (MK-5172A) once daily for 12 weeks (blinded) and were followed-up for 24 weeks. In Part B, participants could enroll in a 3-year follow-up period where they were followed every 6 months for 3 years in an observational cohort (no treatment was administered during Part B).
In Part A, participants received placebo to MK-5172A once daily for 12 weeks (blinded), followed by 4 weeks of follow-up. Afterwards, participants received 12 weeks of open-label treatment with the MK-5172A FDC and were followed-up for 24 weeks. In Part B, participants could enroll in a 3-year follow-up period where they were followed every 6 months for 3 years in an observational cohort (no treatment was administered during Part B).
Overall Number of Participants Analyzed 201 100
Measure Type: Number
Unit of Measure: Percentage of Participants
0.5 1.0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Immediate Treatment Arm: Grazoprevir/Elbasvir, Deferred Treatment Arm: Placebo > Grazoprevir/Elbasvir
Comments Categorical AE parameters were assessed via point estimates with 95% confidence intervals provided for between-treatment differences in the percentage of participants with events using the Miettinen and Nurminen method, an unconditional, asymptotic method.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value -0.5
Confidence Interval (2-Sided) 95%
-5.0 to 1.9
Estimation Comments [Not Specified]
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® AmpliPrep/COBAS® Taqman HCV Test, v2.0, which has an LLOQ of 15 IU/mL. SVR24 was defined as HCV RNA <LLOQ at 24 weeks after the end of all study therapy. The Clopper-Pearson method was used to construct 95% confidence intervals for the SVR24 rate. The secondary efficacy analysis for Part A evaluated the percentage of participants in the immediate treatment arm (ITA) who achieved SVR24. SVR24 was also calculated for the Deferred Treatment Arm.
Time Frame 24 weeks after end of all therapy (Study Week 36 for Immediate Treatment Arm and Study Week 52 for Deferred Treatment Arm)
Hide Outcome Measure Data
Hide Analysis Population Description
Modified FAS (mFAS): All randomized participants receiving ≥1 dose of active study treatment and excluding participants for study discontinuation for reasons unrelated to treatment regimen, response to HCV treatment, or BL genotype (GT)2, GT3, or GT5. The secondary efficacy analysis was evaluated within participants of the Immediate Treatment Arm.
Arm/Group Title Immediate Treatment Arm: Grazoprevir/Elbasvir Deferred Treatment Arm: Placebo > Grazoprevir/Elbasvir
Hide Arm/Group Description:
In Part A, participants received grazoprevir 100 mg plus elbasvir 50 mg FDC (MK-5172A) once daily for 12 weeks (blinded) and were followed-up for 24 weeks. In Part B, participants could enroll in a 3-year follow-up period where they were followed every 6 months for 3 years in an observational cohort (no treatment was administered during Part B).
In Part A, participants received placebo to MK-5172A once daily for 12 weeks (blinded), followed by 4 weeks of follow-up. Afterwards, participants received 12 weeks of open-label treatment with the MK-5172A FDC and were followed-up for 24 weeks. In Part B, participants could enroll in a 3-year follow-up period where they were followed every 6 months for 3 years in an observational cohort (no treatment was administered during Part B).
Overall Number of Participants Analyzed 186 85
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
94.1
(89.7 to 97.0)
96.5
(90.0 to 99.3)
Time Frame Up to approximately 4 years (Study Week 208)
Adverse Event Reporting Description All-Cause Mortality reported for all randomized participants. AEs reported for all randomized participants receiving ≥1 dose of study treatment. AEs were reported by the treatment that participants were receiving at the time of the event; AEs and deaths for Deferred Group reported separately for placebo (N=100) and active (N=95) treatment periods.
 
Arm/Group Title Immediate Treatment Arm: Grazoprevir/Elbasvir Deferred Treatment Arm: Placebo Deferred Treatment Arm: Grazoprevir/Elbasvir
Hide Arm/Group Description In Part A, participants received grazoprevir 100 mg plus elbasvir 50 mg FDC (MK-5172A) once daily for 12 weeks (blinded) and were followed-up for 24 weeks. In Part B, participants could enroll in a 3-year follow-up period where they were followed every 6 months for 3 years in an observational cohort (no treatment was administered during Part B). In Part A, participants received placebo to MK-5172A once daily for 12 weeks (blinded), followed by 4 weeks of follow-up. In Part A, participants received placebo to MK-5172A once daily for 12 weeks (blinded), followed by 4 weeks of follow-up. Afterwards, participants received 12 weeks of open-label treatment with the MK-5172A FDC and were followed-up for 24 weeks. In Part B, participants could enroll in a 3-year follow-up period where they were followed every 6 months for 3 years in an observational cohort (no treatment was administered during Part B).
All-Cause Mortality
Immediate Treatment Arm: Grazoprevir/Elbasvir Deferred Treatment Arm: Placebo Deferred Treatment Arm: Grazoprevir/Elbasvir
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/201 (1.49%)      1/100 (1.00%)      1/95 (1.05%)    
Hide Serious Adverse Events
Immediate Treatment Arm: Grazoprevir/Elbasvir Deferred Treatment Arm: Placebo Deferred Treatment Arm: Grazoprevir/Elbasvir
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   16/201 (7.96%)      4/100 (4.00%)      7/95 (7.37%)    
Cardiac disorders       
Left ventricular failure † 1  1/201 (0.50%)  1 0/100 (0.00%)  0 0/95 (0.00%)  0
Infections and infestations       
Bacteraemia † 1  0/201 (0.00%)  0 1/100 (1.00%)  1 0/95 (0.00%)  0
Cellulitis † 1  1/201 (0.50%)  1 0/100 (0.00%)  0 1/95 (1.05%)  1
Pneumonia † 1  0/201 (0.00%)  0 1/100 (1.00%)  1 0/95 (0.00%)  0
Sepsis † 1  2/201 (1.00%)  2 0/100 (0.00%)  0 0/95 (0.00%)  0
Subcutaneous abscess † 1  0/201 (0.00%)  0 1/100 (1.00%)  1 0/95 (0.00%)  0
Systemic candida † 1  0/201 (0.00%)  0 1/100 (1.00%)  1 0/95 (0.00%)  0
Injury, poisoning and procedural complications       
Accidental overdose † 1  0/201 (0.00%)  0 0/100 (0.00%)  0 1/95 (1.05%)  1
Clavicle fracture † 1  0/201 (0.00%)  0 1/100 (1.00%)  1 0/95 (0.00%)  0
Overdose † 1  1/201 (0.50%)  1 0/100 (0.00%)  0 1/95 (1.05%)  1
Road traffic accident † 1  0/201 (0.00%)  0 0/100 (0.00%)  0 1/95 (1.05%)  1
Skin laceration † 1  0/201 (0.00%)  0 0/100 (0.00%)  0 1/95 (1.05%)  1
Spinal compression fracture † 1  1/201 (0.50%)  1 0/100 (0.00%)  0 0/95 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Bladder cancer stage II † 1  1/201 (0.50%)  1 0/100 (0.00%)  0 0/95 (0.00%)  0
Squamous cell carcinoma † 1  1/201 (0.50%)  1 0/100 (0.00%)  0 0/95 (0.00%)  0
Squamous cell carcinoma of the oral cavity † 1  0/201 (0.00%)  0 0/100 (0.00%)  0 1/95 (1.05%)  1
Nervous system disorders       
Ruptured cerebral aneurysm † 1  1/201 (0.50%)  1 0/100 (0.00%)  0 0/95 (0.00%)  0
Psychiatric disorders       
Bipolar disorder † 1  1/201 (0.50%)  1 0/100 (0.00%)  0 0/95 (0.00%)  0
Completed suicide † 1  1/201 (0.50%)  1 0/100 (0.00%)  0 0/95 (0.00%)  0
Depression † 1  0/201 (0.00%)  0 0/100 (0.00%)  0 1/95 (1.05%)  1
Drug abuse † 1  1/201 (0.50%)  1 0/100 (0.00%)  0 1/95 (1.05%)  1
Hallucination, auditory † 1  1/201 (0.50%)  3 0/100 (0.00%)  0 0/95 (0.00%)  0
Personality disorder † 1  1/201 (0.50%)  1 0/100 (0.00%)  0 0/95 (0.00%)  0
Schizophrenia † 1  1/201 (0.50%)  1 0/100 (0.00%)  0 0/95 (0.00%)  0
Suicidal ideation † 1  1/201 (0.50%)  2 0/100 (0.00%)  0 0/95 (0.00%)  0
Suicide attempt † 1  1/201 (0.50%)  1 0/100 (0.00%)  0 0/95 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Acute respiratory distress syndrome † 1  0/201 (0.00%)  0 1/100 (1.00%)  2 0/95 (0.00%)  0
Emphysema † 1  0/201 (0.00%)  0 1/100 (1.00%)  1 0/95 (0.00%)  0
Pleural fibrosis † 1  0/201 (0.00%)  0 1/100 (1.00%)  1 0/95 (0.00%)  0
Skin and subcutaneous tissue disorders       
Skin ulcer † 1  0/201 (0.00%)  0 1/100 (1.00%)  1 1/95 (1.05%)  1
Vascular disorders       
Deep vein thrombosis † 1  1/201 (0.50%)  1 0/100 (0.00%)  0 0/95 (0.00%)  0
1
Term from vocabulary, MedDRA 21.0
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Immediate Treatment Arm: Grazoprevir/Elbasvir Deferred Treatment Arm: Placebo Deferred Treatment Arm: Grazoprevir/Elbasvir
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   108/201 (53.73%)      46/100 (46.00%)      36/95 (37.89%)    
Gastrointestinal disorders       
Abdominal pain † 1  11/201 (5.47%)  12 4/100 (4.00%)  4 3/95 (3.16%)  3
Constipation † 1  17/201 (8.46%)  17 4/100 (4.00%)  5 2/95 (2.11%)  2
Diarrhoea † 1  20/201 (9.95%)  22 9/100 (9.00%)  11 8/95 (8.42%)  8
Nausea † 1  23/201 (11.44%)  23 9/100 (9.00%)  9 8/95 (8.42%)  8
Vomiting † 1  8/201 (3.98%)  8 7/100 (7.00%)  7 4/95 (4.21%)  5
General disorders       
Fatigue † 1  32/201 (15.92%)  32 20/100 (20.00%)  22 13/95 (13.68%)  14
Injury, poisoning and procedural complications       
Accidental overdose † 1  7/201 (3.48%)  7 4/100 (4.00%)  5 5/95 (5.26%)  5
Metabolism and nutrition disorders       
Decreased appetite † 1  8/201 (3.98%)  8 6/100 (6.00%)  6 3/95 (3.16%)  3
Nervous system disorders       
Headache † 1  26/201 (12.94%)  31 14/100 (14.00%)  20 12/95 (12.63%)  15
Psychiatric disorders       
Insomnia † 1  13/201 (6.47%)  13 6/100 (6.00%)  6 0/95 (0.00%)  0
1
Term from vocabulary, MedDRA 21.0
†
Indicates events were collected by systematic assessment
[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.
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
Publications of Results:
Dore GJ, Altice F, Litwin AH, Dalgard O, Gane EJ, Shibolet O, Luetkemeyer A, Nahass R, Peng CY, Conway B, Grebely J, Howe AY, Gendrano IN, Chen E, Huang HC, Dutko FJ, Nickle DC, Nguyen BY, Wahl J, Barr E, Robertson MN, Platt HL; C-EDGE CO-STAR Study Group. Elbasvir-Grazoprevir to Treat Hepatitis C Virus Infection in Persons Receiving Opioid Agonist Therapy: A Randomized Trial. Ann Intern Med. 2016 Nov 1;165(9):625-634. doi: 10.7326/M16-0816. Epub 2016 Aug 9.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT02105688    
Other Study ID Numbers: 5172-062
2014-000343-32 ( EudraCT Number )
MK-5172-062 ( Other Identifier: Merck )
First Submitted: April 2, 2014
First Posted: April 7, 2014
Results First Submitted: May 26, 2016
Results First Posted: July 11, 2016
Last Update Posted: December 5, 2019