Safety and Tolerability of Boceprevir in Combination With Peginterferon Alfa-2b Plus Ribavirin for the Treatment of Vietnamese Subjects With Chronic Hepatitis C Genotype 1 (P08599)

September 7, 2015 updated by: Merck Sharp & Dohme LLC

An Open-Label Study to Assess the Safety and Tolerability of Boceprevir in Combination With Peginterferon Alfa-2b Plus Ribavirin for Treatment of Vietnamese Subjects With Chronic Hepatitis C Genotype 1 Who Failed Prior Treatment With Any Interferon Plus Ribavirin in Vietnam

This study is designed to assess the safety and tolerability of boceprevir dosed 800 mg three times daily (TID) orally (PO) in combination with Peginterferon alfa-2b (PEG2b) 1.5 mcg/kg once a week (QW) administered subcutaneously (SC) plus ribavirin (RBV) (800 to 1400 mg/day) PO in Response Guided Therapy (RGT) in adult Vietnamese subjects with Chronic Hepatitis C, Genotype 1 (CHC GT1) who failed prior treatment with any interferon and ribavirin in Vietnam.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Each participant will participate in the trial for a maximum of 80 weeks from the time the participant signs the Informed Consent Form (ICF) through the final contact. After a Screening phase of approximately 4 to 8 weeks, each participant will receive treatment for approximately 36-48 weeks depending on response at Treatment Week 8.

A 4-week lead-in period with PEG2b plus RBV will be followed by 32 weeks boceprevir plus PEG2b/RBV. At treatment Week 36 participants will be assigned to the following treatments depending on the virologic response at Week 8 and cirrhotic status:

  1. For non-cirrhotic participants with undetectable hepatitis C virus (HCV)-RNA on Week 8, all treatment will be discontinued at Week 36.
  2. For non-cirrhotic participants with detectable HCV-RNA on Week 8, only boceprevir treatment will be discontinued at Week 36 and PEG2b and RBV treatment will continue to Week 48.
  3. For cirrhotic participants, the boceprevir plus PEG2b/RBV treatment will continue to Week 48.

The study has a futility rule at Week 12 at which point all subjects with detectable HCV-RNA levels will be discontinued. All participants will have a post-treatment follow-up period of at least 24 weeks.

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:

  • Weight ≥ 40 kg to ≤ 125 kg
  • Sexually active male participants and female participants of child-bearing potential must agree to use a medically acceptable form of contraception
  • Must have documented Chronic Hepatitis C Genotype 1 infection
  • Must have failed prior treatment with interferon plus ribavirin
  • Must have completed treatment with interferon plus ribavirin for at least 12 weeks
  • Must have had a liver biopsy or Fibroscan to determine status as cirrhotic or non-cirrhotic
  • Participants with cirrhosis must have had an ultrasound or imaging study within 6 months of the Screening visit

Exclusion Criteria:

  • Known co-infection with the human immunodeficiency virus (HIV) or the hepatitis B virus
  • Prior discontinuation of treatment with interferon or ribavirin due to the occurrence of an adverse event(s) considered by the investigator to be possibly or probably related to the treatment
  • Treatment with ribavirin within 90 days and any interferon within 1 month of the Screening visit
  • Treatment with any investigational drug within 30 days prior to the Screening visit
  • Treatment with midazolam, pimozide, amiodarone, flecainide, propafenone, quinidine, or ergot derivatives within 2 weeks prior to the Day 1 visit
  • Participation in any investigational trial within 30 days of the Screening visit
  • Evidence of decompensated liver disease
  • Child Pugh score > 6 (Class B and C)
  • Diabetic and/or hypertensive participants with clinically significant ocular examination findings
  • Pre-existing psychiatric conditions
  • Clinical diagnosis of substance abuse
  • Active or suspected malignancy
  • Pregnant or nursing

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Peg2b + Ribavirin + Boceprevir
Peginterferon alpha-2b (Peg2b) plus ribavirin (RBV) starting on Day 1 and boceprevir starting on Week 5
Drug: Boceprevir
Boceprevir will be dosed orally at a dose of 800 mg three times daily (TID) for a total daily dose of 2400 mg.
Other Names:
  • SCH 503034
Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week
Peginterferon alpha-2b will be administered subcutaneously at a dose of 1.5 mcg/kg each week.
Other Names:
  • Rebetol®
  • Pegintron®
Drug: Ribavirin
Ribavirin will be administered orally at a dose of 800 mg/day to 1400 mg/day in two divided daily doses (BID).
Other Names:
  • Rebetol®
  • Pegintron®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants Achieving Sustained Virologic Response (SVR)
Time Frame: Follow-Up Week 24
Follow-Up Week 24
Percentage of Participants Experiencing a Serious Adverse Event (SAE) During the Study Therapy Period
Time Frame: Treatment Week 1 to Treatment Week 24
Treatment Week 1 to Treatment Week 24

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

May 1, 2014

Primary Completion (Anticipated)

September 1, 2016

Study Completion (Anticipated)

September 1, 2016

Study Registration Dates

First Submitted

July 11, 2012

First Submitted That Met QC Criteria

July 13, 2012

First Posted (Estimate)

July 17, 2012

Study Record Updates

Last Update Posted (Estimate)

September 9, 2015

Last Update Submitted That Met QC Criteria

September 7, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P08599

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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