Overview

This trial is active, not recruiting.

Condition hepatitis c
Treatments grazoprevir/elbasvir, placebo
Phase phase 3
Sponsor Merck Sharp & Dohme Corp.
Start date January 2015
End date September 2016
Trial size 489 participants
Trial identifier NCT02251990, 5172-067

Summary

This is a randomized, parallel-group, placebo-controlled, multi-site, multinational, double-blind followed by open label period, Phase 3 trial of 100 mg of grazoprevir (MK-5172) in combination with 50 mg of elbasvir (MK-8742) (grazoprevir/elbasvir fixed-dose combination [FDC]) in treatment-naïve (TN) participants with chronic hepatitis C virus (HCV), genotype (GT) 1, 4 or 6 infection. The primary hypothesis is that the proportion of participants receiving grazoprevir/elbasvir FDC in the immediate treatment arm achieving SVR12 (Sustained Virologic Response 12 weeks after the end of all study therapy) will be superior to the reference rate of 73%.

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 take a grazoprevir/elbasvir FDC tablet once daily (q.d.) by mouth for 12 weeks (active treatment period). Participants are then monitored for safety until Week 36.
grazoprevir/elbasvir
FDC tablet containing 100 mg of grazoprevir and 50 mg of elbasvir taken q.d. by mouth for 12 weeks.
(Placebo Comparator)
Participants take a placebo tablet q.d. by mouth for 12 weeks (placebo treatment period). After a 4-week Follow-Up period, participants take grazoprevir/elbasvir FDC during a 12-week Active Treatment period (Week 16 to Week 28). Participants are then monitored for safety until Week 52.
placebo
Placebo tablet matching grazoprevir/elbasvir FDC tablet taken q.d. by mouth for 12 weeks.

Primary Outcomes

Measure
Proportion of participants achieving SVR12
time frame: Week 24
Number of participants experiencing an adverse event (AE)
time frame: Up to Week 14
Number of participants discontinuing from study therapy due to AEs
time frame: Up to Week 12

Secondary Outcomes

Measure
Proportion of participants achieving SVR 4 weeks after ending all study treatment (SVR4)
time frame: Week 16
Proportion of participants achieving SVR 24 weeks after ending all study treatment (SVR24)
time frame: Week 36

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Has documented chronic HCV GT1, GT4, or GT6 (with no evidence of non-typeable or mixed genotype) infection - Has or does not have cirrhosis of the liver - Is abstinent or uses acceptable method(s) of contraception Exclusion Criteria: - Has evidence of decompensated liver disease - Is coinfected with hepatitis B virus or human immunodeficiency virus (HIV) - Shows evidence of hepatocellular carcinoma (HCC) or is under evaluation for HCC - Has a clinically-relevant drug or alcohol abuse within 12 months of screening - Is pregnant or breast-feeding - Has any condition or abnormality that might confound the results of the trial or pose an additional risk to the subject

Additional Information

Official title A Phase III Randomized Multinational Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172/MK-8742 in Treatment-Naïve Subjects With Chronic HCV GT 1, GT 4 and GT 6 Infection
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Merck Sharp & Dohme Corp..