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

NCT ID: NCT01425203

Last Updated: 2021-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 238 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-23
• Study Completion Date: 2013-10-21

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

RGT BOC + PR

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.

Group Type: EXPERIMENTAL

Boceprevir

Intervention Type: DRUG

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

peginterferon alfa-2b

Intervention Type: BIOLOGICAL

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

Ribavirin

Intervention Type: DRUG

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

PBO + PR (Control)

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

peginterferon alfa-2b

Intervention Type: BIOLOGICAL

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

Ribavirin

Intervention Type: DRUG

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

Crossover Arm

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.

Group Type: EXPERIMENTAL

Boceprevir

Intervention Type: DRUG

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

peginterferon alfa-2b

Intervention Type: BIOLOGICAL

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

Ribavirin

Intervention Type: DRUG

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

Interventions

Boceprevir

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

peginterferon alfa-2b

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

Intervention Type: BIOLOGICAL

Ribavirin

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

Intervention Type: DRUG

Other Intervention Names

SCH 503034; PegIntron

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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.

Reference Type: RESULT

PMID: 26962399 (View on PubMed)

Study Documents

Document Type: CSR Synopsis

View Document

Other Identifiers

MK-3034-046

Identifier Type: OTHER

Identifier Source: secondary_id

P08160

Identifier Type: -

Identifier Source: org_study_id