Phase 3
Completed N=238
The Effect of Boceprevir in Russian Participants Diagnosed With Chronic Hepatitis C Genotype 1 (P08160)
Chronic Hepatitis C Genotype 1
Source: ClinicalTrials.gov NCT01425203 ↗
Enrolled (actual)
238
Serious AEs
10.2%
Results posted
Aug 2014
Primary outcomePrimary: 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) — 74.8; 46.2 percentage of participants — p=<0.0001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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) |
74.8; 46.2 | <0.0001 sig |
| SECONDARY Percentage of Participants Achieving SVR24 Among Participants Who Received At Least One Dose of Experimental Trial Drug (Modified Intent-To-Treat [mITT] Population) |
76.3; 46.8 | <0.0001 sig |
| SECONDARY Percentage of Participants Achieving Early Virologic Response (EVR) At Treatment Week (TW) 8 |
87.4; 42.3 | <0.0001 sig |
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
Data sourced from ClinicalTrials.gov (NCT01425203). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.