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

NCT01425203 | Completed Phase 3 Results

• 2 other identifiers: P08160MK-3034-046
• Study Type: interventional
• Target: 238
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine whether Boceprevir (BOC, SCH 503034, MK-3034) in combination with Peginterferon Alfa 2-b (PEG) plus Ribavirin (RBV) \[PEG+RBV=PR\] is effective in the treatment of chronic hepatitis C (CHC) genotype 1 among the Russian population. The primary hypothesis is that the percentage of participants achieving sustained virologic response in the BOC + PR group is superior to that in the Placebo (PBO) + PR group.

Conditions

Chronic Hepatitis C Genotype 1

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving Sustained Virologic Response At Follow-up Week 24 (SVR24) Among Participants Who Received At Least One Dose of Any Trial Medication (Full Analysis Set Population)

  SVR24 was defined as an undetectable plasma Hepatitis C Virus-ribonucleic acid (HCV-RNA) level at Follow-up Week 24 (FW24). If a participant was missing FW24 data and had undetectable HCV-RNA at FW12, the participant was considered a sustained virologic responder.

  Follow-up Week 24 (up to 72 weeks)

Secondary Outcomes (2)

• Percentage of Participants Achieving SVR24 Among Participants Who Received At Least One Dose of Experimental Trial Drug (Modified Intent-To-Treat [mITT] Population)

  Follow-up Week 24 (up to 72 weeks)

• Percentage of Participants Achieving Early Virologic Response (EVR) At Treatment Week (TW) 8

  Treatment Week 8

Study Arms (3)

RGT BOC + PR

EXPERIMENTAL

Participants received PR for 4 weeks before addition of BOC. Participants then received response guided therapy (RGT) with BOC + PR for up to 32 weeks followed by PBO + PR for up to 20 weeks.

Drug: Boceprevir; Biological: peginterferon alfa-2b; Drug: Ribavirin

PBO + PR (Control)

PLACEBO COMPARATOR

Participants received PR for 4 weeks before addition of BOC-matched PBO. Participants then received BOC + PR for up to 44 weeks.

Drug: Placebo; Biological: peginterferon alfa-2b; Drug: Ribavirin

Crossover Arm

EXPERIMENTAL

Participants randomized to the PBO + PR Control arm who failed the futility rule at treatment week (TW) 12 or 24 were rolled over to the Crossover arm and received BOC + PR.

Drug: Boceprevir; Biological: peginterferon alfa-2b; Drug: Ribavirin

Interventions

Boceprevir DRUG

boceprevir 200-mg capsules, 800 mg 3 times a day (TID), orally (PO)

Also known as: SCH 503034

Crossover Arm; RGT BOC + PR

Placebo DRUG

boceprevir-matched placebo four 200-mg capsules PO TID.

PBO + PR (Control)

peginterferon alfa-2b BIOLOGICAL

peginterferon alfa-2b 1.5 μg/kg/wk subcutaneously (SC)

Also known as: PegIntron

Crossover Arm; PBO + PR (Control); RGT BOC + PR

Ribavirin DRUG

ribavirin (weight-based dosing) 800 to 1400 mg/day PO divided twice daily dose (BID).

Crossover Arm; PBO + PR (Control); RGT BOC + PR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• Isakov V, Nikitin I, Chulanov V, Ogurtsov P, Lukyanova E, Long J, Wahl J, Helmond FA; P08160 Trial Investigators. Boceprevir plus peginterferon/ribavirin for treatment of chronic hepatitis C in Russia. World J Hepatol. 2016 Feb 28;8(6):331-9. doi: 10.4254/wjh.v8.i6.331.

  PMID: 26962399 RESULT

MeSH Terms

Interventions

N-(3-amino-1-(cyclobutylmethyl)-2,3-dioxopropyl)-3-(2-((((1,1-dimethylethyl)amino)carbonyl)amino)-3,3-dimethyl-1-oxobutyl)-6,6-dimethyl-3-azabicyclo(3.1.0)hexan-2-carboxamide; peginterferon alfa-2b; Ribavirin

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Vice President, Late Stage Development Group Leader
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2011
• First Posted: August 29, 2011
• Study Start: November 23, 2011
• Primary Completion: October 21, 2013
• Study Completion: October 21, 2013
• Last Updated: February 8, 2021
• Results First Posted: August 18, 2014

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share