Grazoprevir (MK-5172) and Elbasvir (MK-8742) Combination in Treatment-Naïve Hepatitis C Virus Participants (MK-5172-067)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

489 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-28

Study Completion Date

2017-04-10

Brief Summary

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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 percentage of participants receiving grazoprevir/elbasvir FDC in the Immediate Treatment Group (ITG) achieving Sustained Virologic Response 12 weeks after the end of all study therapy (SVR12) will be superior to the historical reference rate of 73%.

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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 Group (ITG): Grazoprevir/Elbasvir

Participants receive a grazoprevir/elbasvir FDC tablet once daily (q.d.) by mouth during a 12-week Active Treatment period (Week 1 to Week 12) and are followed-up for 24 weeks to Week 36.

Group Type EXPERIMENTAL

Grazoprevir/Elbasvir

Intervention Type DRUG

FDC tablet containing 100 mg of grazoprevir and 50 mg of elbasvir taken q.d. by mouth for 12 weeks.

Deferred Treatment Group (DTG): Placebo > Grazoprevir/Elbasvir

Participants receive a placebo tablet q.d. by mouth for 12 weeks (placebo treatment period). After a 4-week Follow-Up period, participants receive open-label grazoprevir/elbasvir FDC during a 12-week Active Treatment period (Week 16 to Week 28). Participants are then followed-up for 24 weeks to Week 52.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo tablet matching grazoprevir/elbasvir FDC tablet taken q.d. by mouth for 12 weeks.

Interventions

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Grazoprevir/Elbasvir

FDC tablet containing 100 mg of grazoprevir and 50 mg of elbasvir taken q.d. by mouth for 12 weeks.

Intervention Type DRUG

Placebo

Placebo tablet matching grazoprevir/elbasvir FDC tablet taken q.d. by mouth for 12 weeks.

Intervention Type DRUG

Other Intervention Names

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MK-5172A

Eligibility Criteria

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Inclusion Criteria

* Has documented chronic HCV GT1, GT4, or GT6 (with no evidence of non-typeable or mixed genotype) infection
* Meets clinical criteria for presence or absence of cirrhosis based on liver disease staging assessment
* 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 participant

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No