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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01425203
Other study ID # P08160
Secondary ID MK-3034-046
Status Completed
Phase Phase 3
First received
Last updated
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
Health authority
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

Study Design


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
See also
  Status Clinical Trial Phase
Completed NCT04246723 - Efficacy and Safety of All-Oral Combination of Narlaprevir/Ritonavir and Sofosbuvir in Treatment-naïve Patients With Chronic Hepatitis C Genotype 1 Phase 2