The Effect of Boceprevir in Russian Participants Diagnosed With Chronic Hepatitis C Genotype 1 (P08160 AM2)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01425203
First received: August 26, 2011
Last updated: November 4, 2013
Last verified: November 2013
  Purpose

The purpose of this study is to determine whether Boceprevir (BOC) in combination with Peginterferon Alfa 2-b (PEG) plus Ribavirin (RBV) is effective in the treatment of chronic hepatitis C (CHC) genotype 1 among the Russian population.


Condition Intervention Phase
Chronic Hepatitis C Genotype 1
Drug: Boceprevir
Drug: Placebo
Drug: peginterferon alfa-2b
Drug: Ribavirin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Boceprevir in Combination With Peginterferon Alfa-2bPlus Ribavirin for Treatment of Chronic Hepatitis C Genotype 1 in Russia: Previously Untreated Patients and Patients Who Failed Prior Treatment With Pegylated-Interferon Plus Ribavirin

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Number of Participants Achieving Sustained Virologic Response (SVR) At Follow-up Week 24 in Participants who Received At Least One Dose of Any Trial Medication (i.e. PEG, RBV, BOC, or Placebo) [ Time Frame: Follow-up Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of Participants Achieving Sustained Virologic Response (SVR) At Follow-up Week 24 (Modified Intent To Treat Population) [ Time Frame: Follow-up Week 24 ] [ Designated as safety issue: No ]
  • Number of Participants Achieving Early Virologic Response (EVR) At Week 8 [ Time Frame: Treatment Week 8 ] [ Designated as safety issue: No ]

Enrollment: 238
Study Start Date: November 2011
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BOC+PEG+RBV
Participants received PEG + RBV (weight-based dose) for 4 weeks before addition of BOC. Participants then received combination treatment with all 3 therapies for up to 32 weeks followed by placebo + PEG + RBV for up to 20 weeks.
Drug: Boceprevir
boceprevir 200-mg capsules, 800 mg 3 times a day (TID), orally (PO)
Other Name: SCH 503034
Drug: peginterferon alfa-2b
peginterferon alfa-2b 1.5 μg/kg/wk subcutaneously (SC)
Other Name: PegIntron
Drug: Ribavirin
ribavirin (weight-based dosing) 800 to 1400 mg/day PO divided twice daily dose (BID).
Placebo Comparator: Placebo+PEG+RBV (Control)
Participants received PEG + RBV for 4 weeks before addition of BOC-matched placebo. Participants then received combination treatment with all 3 therapies for up to 44 weeks.
Drug: Placebo
boceprevir-matched placebo four 200-mg capsules orally, three times daily (TID)
Drug: peginterferon alfa-2b
peginterferon alfa-2b 1.5 μg/kg/wk subcutaneously (SC)
Other Name: PegIntron
Drug: Ribavirin
ribavirin (weight-based dosing) 800 to 1400 mg/day PO divided twice daily dose (BID).
Experimental: Cross-over Combination
Participants randomized to the Placebo + PEG + RBV Control arm who failed the futility rule at treatment week 12 or 24 were rolled over to the Cross-over arm and received BOC+PEG+RBV
Drug: Boceprevir
boceprevir 200-mg capsules, 800 mg 3 times a day (TID), orally (PO)
Other Name: SCH 503034
Drug: peginterferon alfa-2b
peginterferon alfa-2b 1.5 μg/kg/wk subcutaneously (SC)
Other Name: PegIntron
Drug: Ribavirin
ribavirin (weight-based dosing) 800 to 1400 mg/day PO divided twice daily dose (BID).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • body weight ≥40 kg and ≤125 kg
  • previously documented CHC genotype 1 infection;
  • must have a liver biopsy with histology consistent with CHC and no other etiology
  • if cirrhosis present, must have an ultrasound within 6 months of the screening

visit (or between screening and Day 1) with no findings suspicious for hepatocellular carcinoma (HCC)

  • agree to use acceptable methods of contraception with partner
  • previously untreated with pegylated-interferon (either alfa-2a or alfa-2b) plus RBV or failing prior treatment with pegylated-interferon (either alfa-2a or alfa-2b) plus RBV

Exclusion criteria:

- co-infected with the human immunodeficiency virus (HIV) or hepatitis B virus (Hepatitis B

surface antigen [HBsAg] positive).

  • required discontinuation of previous interferon or ribavirin regimen for an adverse event (possibly or probably related)
  • treatment with ribavirin within 90 days and any interferon-alpha, based on the amendment, should be within 1 month prior to screening
  • treatment with any investigational drug within 30 days of the screening visit in this trial
  • evidence of decompensated liver disease including, but not limited to, a history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy
  • diabetic and/or hypertensive with clinically significant ocular examination findings
  • clinical diagnosis of substance abuse of specified drugs within specified

timeframes

-any known pre-existing medical condition that could interfere with the participant's participation in and completion of the trial

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01425203     History of Changes
Other Study ID Numbers: P08160, 2010-024260-17
Study First Received: August 26, 2011
Last Updated: November 4, 2013
Health Authority: Russia: Ministry of Health of the Russian Federation

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Ribavirin
Peginterferon alfa-2b
Interferon-alpha
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 23, 2014