Grazoprevir (MK-5172) and Elbasvir (MK-8742) Combination for Chronic Hepatitis C Virus (HCV) Genotypes 1, 4, and 6 (MK-5172-065)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

159 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-22

Study Completion Date

2016-06-14

Brief Summary

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This is a randomized, multi-site, placebo-controlled trial of a fixed dose combination (FDC) of grazoprevir (MK-5172) 100 mg + elbasvir (MK-8742) 50 mg in participants with chronic Hepatitis C Virus (HCV) genotype (GT) 1, GT4 or GT6 with inherited blood disorders. The primary hypothesis is that the proportion of participants treated with grazoprevir+elbasvir achieving Sustained Virologic Response (SVR) 12 weeks after the end of all study therapy (SVR12) will be greater than the reference rate of 40%.

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Detailed Description

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Conditions

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Hepatitis C

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Immediate Treatment

Participants will take grazoprevir 100 mg + elbasvir 50 mg once daily during the 12-week treatment period and then will be monitored for safety during a 24-week follow-up period.

Group Type EXPERIMENTAL

Grazoprevir + Elbasvir

Intervention Type DRUG

FDC tablet containing grazoprevir 100 mg + elbasvir 50 mg taken once daily by mouth.

Deferred Treatment

Participants will take placebo tablets once daily during the 12-week treatment period and will then be monitored for safety during a 4-week follow-up period. Participants will then begin open-label treatment with grazoprevir 100 mg + elbasvir 50 mg for a 12-week treatment period and will then be monitored for safety during a 24-week follow-up period.

Group Type PLACEBO_COMPARATOR

Grazoprevir + Elbasvir

Intervention Type DRUG

FDC tablet containing grazoprevir 100 mg + elbasvir 50 mg taken once daily by mouth.

Placebo

Intervention Type DRUG

Placebo tablets matching grazoprevir + elbasvir FDC tablets taken once daily by mouth.

Interventions

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Grazoprevir + Elbasvir

FDC tablet containing grazoprevir 100 mg + elbasvir 50 mg taken once daily by mouth.

Intervention Type DRUG

Placebo

Placebo tablets matching grazoprevir + elbasvir FDC tablets taken once daily by mouth.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* has HCV GT1, GT4, or GT6 with sickle cell anemia, thalassemia, or hemophilia/von Willebrand disease
* has cirrhosis or is non-cirrhotic
* is human immunodeficiency virus (HIV) coinfected or not infected with HIV
* is a female of non childbearing potential, or is male or female and uses an acceptable method(s) of contraception

Exclusion Criteria

* has evidence of decompensated liver disease
* is coinfected with hepatitis B
* has had a malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer
* has hepatocellular carcinoma (HCC) or is under evaluation for HCC
* has clinically-relevant drug or alcohol abuse within 12 months of screening

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No