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

Chronic Hepatitis C Genotype 1 Clinical Trial

Official title:

Safety and Efficacy of Boceprevir in Combination With Peginterferon Alfa-2b Plus 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01425203
• Other study ID #: P08160
• Secondary ID: MK-3034-046
• Status: Completed
• Phase: Phase 3
• Start date: November 23, 2011
• Est. completion date: October 21, 2013

Study information

• Verified date: January 2021
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 238
• Est. completion date: October 21, 2013
• Est. primary completion date: October 21, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Hepatitis C Genotype 1
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• Boceprevir
boceprevir 200-mg capsules, 800 mg 3 times a day (TID), orally (PO)
• Placebo
boceprevir-matched placebo four 200-mg capsules PO TID.

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

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage of Participants Achieving SVR24 Among Participants Who Received At Least One Dose of Experimental Trial Drug (Modified Intent-To-Treat [mITT] Population)	SVR24 was defined as an undetectable plasma HCV-RNA level at 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	Percentage of Participants Achieving Early Virologic Response (EVR) At Treatment Week (TW) 8	EVR was defined as an undetectable HCV-RNA level at TW 8. This analysis was conducted when all participants had completed 8 weeks of the study or had discontinued prior to TW 8.	Treatment Week 8