Phase 4
Completed N=58
A Study to Evaluate the Efficacy and Safety of Boceprevir Added to Standard of Care Therapy in Previously Treated Participants With Chronic Hepatitis C Genotype 1 and Cirrhosis (MK-3034-105)
Source: ClinicalTrials.gov NCT01756079 ↗Enrolled (actual)
58
Serious AEs
17.2%
Results posted
Nov 2016
Primary outcomePrimary: Percentage of Participants Who Achieve Sustained Virological Response at Follow-up Week 24 (SVR24) — 35.2 Percentage of participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This study is being done to find out if the addition of boceprevir to standard of care (SOC) treatment with peginterferon alfa-2b (PegIFN-2b) + ribavirin (RBV) is effective for participants with chronic hepatitis C (CHC) genotype 1 and cirrhosis who were not successfully treated by previous SOC. All participants will receive treatment with SOC alone for 4 weeks and then boceprevir will be added to the treatment regimen for 44 additional weeks of combined treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Achieve Sustained Virological Response at Follow-up Week 24 (SVR24) |
35.2 | — |
| PRIMARY Percentage of Participants With One or More Adverse Events |
98.1 | — |
| PRIMARY Percentage of Participants With an Adverse Event Leading to Discontinuation of Study Medication |
9.3 | — |
Eligibility Criteria
Inclusion criteria
- Weight between 40 kg and 125 kg
- Documented CHC genotype 1 infection
- Previous course of treatment with SOC (PegIFN-2a or PegIFN-2b + RBV) with a documented non-response
- Documented diagnosis of cirrhosis
- No evidence of hepatocellular carcinoma (HCC) by ultrasound
- Participant and partner of participant must agree to use 2 effective contraceptives as specified for at least 2 weeks prior to Day 1 of treatment and continue until at least 6 months after last dose of study drug (7 months for male participants)
Exclusion criteria
- Co-infection with human immunodeficiency virus (HIV) or hepatitis B virus
- Use of any investigational drugs within 30 days prior to study enrollment
- Participation in any other clinical trial within 30 days of study enrollment or intention to participate in another clinical trial during this study
- Evidence of present or previous decompensated liver disease including, but not limited to, a history or presence of clinical ascites or hepatic encephalopathy. Only participants with large (F3) esophageal varices, as determined in an esophagogastroduodenoscopy (EGD) performed within the past 12 months according to international guidelines will be excluded.
- Clinically significant ocular examination findings
- Pre-existing significant psychiatric condition(s)
- Clinical diagnosis of active or recent substance abuse
- Evidence of active or suspected malignancy, or a history of malignancy, within the last 3 years (except adequately treated carcinoma in situ and basal cell carcinoma of the skin)
Data sourced from ClinicalTrials.gov (NCT01756079). 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.