Grazoprevir (MK-5172)/Elbasvir (MK-8742) Versus Boceprevir/Pegylated Interferon/Ribavarin for Chronic Hepatitis C Infection (MK-5172-066)

October 13, 2015 updated by: Merck Sharp & Dohme LLC

A Phase III, Open-Label Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172/MK-8742 Versus Boceprevir/Pegylated Interferon/Ribavirin (PR) in Treatment-Naïve and PR Prior Treatment Failure Subjects With Chronic HCV GT1 Infection

This is a randomized, multi-site, open-label trial of a fixed-dose combination of Grazoprevir (MK-5172) and Elbasvir (MK-8742) versus Boceprevir (BOC) / Pegylated Interferon (P) and Ribavirin (R) in treatment-naive and prior treatment failure genotype (GT) 1 hepatitis C virus (HCV)-infected participants. The primary hypothesis is that the proportion of treatment-naive (TN) and prior treatment failure (PTF) participants treated with grazoprevir + elbasvir achieving sustained virologic response (undetectable HCV ribonucleic acid [RNA]) 12 weeks after the end of study therapy (SVR12) will be greater than the proportion of BOC/PR-treated participants achieving SVR12.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

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 RNA ≥ 10,000 IU/mL at the time of screening
  • Has documented chronic HCV GT 1 with no evidence of non-typeable or mixed GT infection
  • Is cirrhotic or non-cirrhotic
  • Has HCV treatment status that is treatment naïve, PR null responder; PR partial responder; or prior PR relapser
  • If human immunodeficiency virus (HIV) co-infected (HIV-1) must be naïve to treatment with any antiretroviral therapy (ART) and have no plans to initiate ART treatment while participating in this trial, or be on HIV ART for at least 8 weeks prior to trial entry (no changes in HIV regimen are allowed within 4 weeks of registration); must also have at least one viable antiretroviral therapy alternative beyond their current regimens in the event of HIV virologic failure and the development of antiretroviral drug resistance
  • Use an acceptable method of contraception or not be of childbearing potential

Exclusion Criteria:

  • Has evidence of decompensated liver disease manifested by the presence of or history of ascites, esophageal or gastric variceal bleeding, hepatic encephalopathy or other signs or symptoms of advanced liver disease
  • Is co-infected with hepatitis B virus (e.g., hepatitis B surface antigen [HBsAg] positive)
  • Has a history of malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer or carcinoma in situ; or is under evaluation for other active or suspected malignancy
  • Has cirrhosis and liver imaging within 6 months of Day 1 showing evidence of hepatocellular carcinoma (HCC) or is under evaluation for HCC
  • Has pre-existing psychiatric condition(s)
  • Has clinically-relevant drug or alcohol abuse within 12 months of screening
  • Is a female and is pregnant or breast-feeding, or expecting to become pregnant or donate eggs from Day 1 throughout treatment and until at least 6 months after the last dose of study medication, or longer if dictated by local regulations; or is a male subject and is planning to impregnate or provide sperm donation
  • Has any preexisting condition or prestudy laboratory abnormality, electrocardiogram (ECG) abnormality or history of any illness, which, in the opinion of the investigator, might confound the results of the trial or pose additional risk in administering the study drug(s) to the subject
  • Has a life-threatening severe AE (SAE) during the screening period
  • Has evidence of history of chronic hepatitis not caused by HCV, including but not limited to nonalcoholic steatohepatitis (NASH), drug-induced hepatitis, and autoimmune hepatitis

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: BOC/PR
All participants begin treatment with a 4-week lead-in of PR followed by 24 weeks of BOC/PR. At Treatment Week (TW) 28 TN participants who have undetectable HCV RNA at TW 8 will complete BOC/PR therapy. At TW 28 TN participants who have detectable HCV RNA at TW 8, as well as prior relapsers and prior partial responders, will continue on BOC/PR for an additional 8 weeks and then continue on PR for an additional 12 weeks. At TW 28 all cirrhotics and previous null responders will continue on BOC/PR for an additional 20 weeks.
Drug: Boceprevir
Participants take Boceprevir (BOC) 800 mg three times daily (TID) PO.
Drug: PegIntron
Participants take 1.5 mcg/kg PegIntron (P) once weekly (QW) via subcutaneous injection.
Other Names:
  • Pegylated Interferon
Drug: Ribavarin
Participants take Ribavarin (R) 800-1400 mg (depending on body weight) twice daily (BID) PO.
Experimental: Grazoprevir/Elbasvir
Participants will undergo treatment with grazoprevir 100 mg + elbasvir 50 mg for 12 weeks.
Drug: Grazoprevir/Elbasvir
Participants take a fixed-dose combination of grazoprevir 100 mg and elbasvir 50 mg once daily (QD) by mouth (PO).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of participants achieving SVR12
Time Frame: Up to Week 60
Up to Week 60

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of TN participants achieving SVR12
Time Frame: Up to Week 60
Up to Week 60
Number of participants experiencing an adverse event (AE)
Time Frame: Up to Week 72
Up to Week 72
Number of participants withdrawing from study treatment due to AEs
Time Frame: Up to Week 72
Up to Week 72
Proportion of PTF participants achieving SVR12
Time Frame: Up to Week 60
Up to Week 60

Collaborators and Investigators

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

Sponsor

Merck Sharp & Dohme LLC

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

November 1, 2014

Primary Completion (Anticipated)

June 1, 2016

Study Completion (Anticipated)

September 1, 2016

Study Registration Dates

First Submitted

July 28, 2014

First Submitted That Met QC Criteria

July 28, 2014

First Posted (Estimate)

July 30, 2014

Study Record Updates

Last Update Posted (Estimate)

October 14, 2015

Last Update Submitted That Met QC Criteria

October 13, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5172-066
  • 2014-001841-25 (EudraCT Number)

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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