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

September 3, 2018 updated by: Merck Sharp & Dohme LLC

A Phase III Double Blind Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172 and MK-8742 in Subjects With Chronic HCV GT1, GT4 and GT6 Infection With Inherited Blood Disorders With and Without HIV Co-Infection

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%.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

159

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Grazoprevir + Elbasvir
FDC tablet containing grazoprevir 100 mg + elbasvir 50 mg taken once daily by mouth.
Placebo Comparator: 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.
Drug: Grazoprevir + Elbasvir
FDC tablet containing grazoprevir 100 mg + elbasvir 50 mg taken once daily by mouth.
Drug: Placebo
Placebo tablets matching grazoprevir + elbasvir FDC tablets taken once daily by mouth.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After Completing Study Therapy (SVR12)
Time Frame: 12 weeks after completing study therapy (Week 24)
The percentage of participants in the both arms achieving SVR12 (i.e., HCV riboncleic acid [RNA] level below the lower limit of quantification [LLoQ] 12 weeks after completing study therapy) was determined. HCV RNA levels were measured using the Roche COBAS™ Taqman™ HCV Test v2.0 (High Pure System), which has a LLoQ of <15 IU/mL.
12 weeks after completing study therapy (Week 24)
Percentage of Participants Experiencing an Adverse Event (AE)
Time Frame: Up to Week 14
An AE is any untoward medical occurrence which does not necessarily have to have a causal relationship with this treatment.
Up to Week 14
Percentage of Participants Discontinuing From Study Treatment Due to an AE(s)
Time Frame: Up to Week 12
An AE is any untoward medical occurrence which does not necessarily have to have a causal relationship with this treatment.
Up to Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After Completing Study Therapy (SVR24)
Time Frame: 24 weeks after completing study therapy (Week 36)
The percentage of participants in both arms achieving SVR24 (i.e., HCV RNA level below the LLoQ 24 weeks after completing study therapy) was determined. HCV RNA levels were measured using the Roche COBAS™ Taqman™ HCV Test v2.0 (High Pure System), which has a LLoQ of <15 IU/mL.
24 weeks after completing study therapy (Week 36)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 22, 2014

Primary Completion (Actual)

December 7, 2015

Study Completion (Actual)

June 14, 2016

Study Registration Dates

First Submitted

September 25, 2014

First Submitted That Met QC Criteria

September 25, 2014

First Posted (Estimate)

September 29, 2014

Study Record Updates

Last Update Posted (Actual)

October 3, 2018

Last Update Submitted That Met QC Criteria

September 3, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5172-065
  • 2014-002356-27 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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