Overview

This trial is active, not recruiting.

Condition chronic hepatitis c
Treatments grazoprevir 100 mg/elbasvir 50 mg fdc tablets, placebo to grazoprevir 100 mg/elbasvir 50 mg fdc tablets
Phase phase 3
Sponsor Merck Sharp & Dohme Corp.
Start date September 2014
End date June 2015
Trial size 301 participants
Trial identifier NCT02105688, 2014-000343-32, 5172-062

Summary

This is a 2-part study. The purpose of Part A is to assess the efficacy and safety of grazoprevir (MK-5172) 100 mg in combination with elbasvir (MK-8742) 50 mg for 12 weeks in the treatment of chronic hepatitis C virus (HCV) genotype 1 (GT1), GT4, or GT6 infection in treatment-naïve participants who are on opiate substitution therapy (OST). The primary hypothesis is that the percentage of participants who receive grazoprevir/elbasvir fixed-dose combination (FDC) in the Immediate Treatment Arm and achieve a Sustained Virologic Response 12 weeks after the end of all study therapy (SVR12) will be superior to 67%. In addition, participants who received at least 1 dose of grazoprevir/elbasvir in Part A will be eligible to participate in Part B, which is a 3-year observational follow-up.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
Participants receive grazoprevir 100 mg/elbasvir 50 mg FDC tablets (blinded) for 12 weeks.
grazoprevir 100 mg/elbasvir 50 mg fdc tablets MK-5172A
Grazoprevir 100 mg/Elbasvir 50 mg FDC tablets, taken once daily by mouth for 12 weeks.
(Placebo Comparator)
Participants receive placebo to grazoprevir 100 mg/elbasvir 50 mg FDC tablets (blinded) for 12 weeks followed by 4 weeks of follow-up and then open-label grazoprevir 100 mg/elbasvir 50 mg FDC for 12 weeks.
grazoprevir 100 mg/elbasvir 50 mg fdc tablets MK-5172A
Grazoprevir 100 mg/Elbasvir 50 mg FDC tablets, taken once daily by mouth for 12 weeks.
placebo to grazoprevir 100 mg/elbasvir 50 mg fdc tablets
Grazoprevir 100 mg/Elbasvir 50 mg FDC placebo tablets, taken once daily by mouth for 12 weeks.

Primary Outcomes

Measure
Percentage of participants achieving Sustained Virologic Response 12 weeks after the end of all study therapy (SVR12)
time frame: Follow-up Week 12 (Up to 24 weeks)
Percentage of participants experiencing adverse events
time frame: Up to 36 weeks
Percentage of participants discontinuing study drug due to adverse events
time frame: Up to 12 weeks

Secondary Outcomes

Measure
Percentage of participants achieving Sustained Virologic Response 24 weeks after the end of all study therapy (SVR24)
time frame: Follow-up Week 24 (Up to 36 weeks)

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Documented chronic HCV genotype 1 (GT1), GT4, or GT6 infection with no evidence of GT2 or GT3 or non-typeable genotypes and HCV ribonucleic acid (RNA) confirmed by screening lab results prior to randomization - On opiate substitution therapy (OST; methadone, levamethadone, buprenorphine, naloxone, naltrexone) for at least 3 months prior to screening - Treatment naïve to all HCV therapies - Human Immunodeficiency Virus (HIV)-infected participants enrolled in this study must meet following criteria: - Documented HIV infection - Naïve to treatment with any antiretroviral therapy (ART) OR on HIV ART for at least 8 weeks prior to study entry using a dual nucleoside reverse transcriptase inhibitor (NRTI) backbone of tenofovir or abacavir and either emtricitabine or lamivudine PLUS raltegravir (or dolutegravir or rilpivirine). Dose modifications or changes in ART during the 4 weeks prior to study entry (Day 1) are not permitted - Cluster of differentiation 4 (CD4+) T-cell count >200 cells/mm^3 if on ART or >500 cell/mm^3 if ART treatment naïve - Undetectable plasma HIV-1 RNA at least 8 weeks prior to screening if on ART or <50,000 copies/mL if ART treatment naïve - Participants with HIV-1 infection and on ART must have at least one viable antiretroviral regimen alternative beyond their current regimen in the event of HIV virologic failure or the development of anti-retroviral drug resistance - Females who are of reproductive potential must agree to avoid becoming pregnant while receiving study drug and for 14 days after the last dose of study drug by complying with one of the following: (1) practice abstinence from heterosexual activity OR (2) use (or have her partner use) acceptable contraception during heterosexual activity Exclusion Criteria: - Evidence of decompensated liver disease - For participants with cirrhosis, participants who are Child-Pugh Class B or C or who have a Pugh-Turcotte (CPT) score >6 - Is co-infected with hepatitis B virus - Has cirrhosis and liver imaging within 6 months of Day 1 showing evidence of hepatocellular carcinoma (HCC) or is under evaluation for HCC - Currently using or intends to use barbiturates during the treatment period of this study - Is a female and is pregnant or breast-feeding, or expecting to conceive or donate eggs from Day 1 or anytime during treatment, and 14 days after the last dose of study medication, or longer if dictated by local regulations - Any medical condition requiring or likely to require chronic systemic administration of corticosteroids, Tumor Necrosis Factor (TNF) antagonists, or other immunosuppressant drugs during the course of the trial - Evidence or history of chronic hepatitis not caused by HCV

Additional Information

Official title A Phase III Randomized Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172/MK-8742 in Treatment-Naïve Subjects With Chronic HCV GT1, GT4, and GT6 Infection Who Are on Opiate Substitution Therapy
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by Merck Sharp & Dohme Corp..