Phase 3
Completed N=257
Short Duration Versus Standard Response-Guided Therapy With Boceprevir Combined With PegIntron and Ribavirin in Previously Untreated Non-Cirrhotic Asian Participants With Chronic HCV Genotype 1 (MK-3034-107)
Hepatitis C, Chronic
Source: ClinicalTrials.gov NCT01945294 ↗
Enrolled (actual)
257
Serious AEs
7.4%
Results posted
Nov 2016
Primary outcomePrimary: Percentage of Participants With Undetectable HCV RNA Who Achieve Sustained Viral Response at Follow-up Week 12 (SVR12) [16-Week Arm vs. 28-Week Arm] — 70.6; 81.9 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 This can indicate results are unpublished — a known publication-bias signal.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
The purpose of this study is to estimate the difference in the efficacy between a 16-week treatment regimen of boceprevir (BOC) in combination with peg-intron alpha 2b (P) plus ribavirin (R) (BOC + PR) and a 28-week treatment regimen of BOC + PR in previously untreated participants with chronic hepatitis C (CHC) genotype 1 in Asia who achieve undetectable hepatitis C virus ribonucleic acid (HCV RNA).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Undetectable HCV RNA Who Achieve Sustained Viral Response at Follow-up Week 12 (SVR12) [16-Week Arm vs. 28-Week Arm] |
70.6; 81.9 | — |
| SECONDARY Percentage of Participants With Undetectable HCV RNA Across Treatment |
24.8; 17.1; 0.0; 100.0; 100.0; 0.0 | — |
| SECONDARY Percentage of Participants Achieving SVR12 Among Participants With Undetectable HCV RNA Across Treatment |
24.5; 14.3; 0.0; 69.6; 81.0; 0.0 | — |
| SECONDARY Percentage of Participants With Relapse |
20.4; 1.1; 0.0 | — |
| SECONDARY Percentage of Participants With Neutropenia |
10.8; 12.4; 4.0 | — |
| SECONDARY Percentage of Participants With Anemia |
33.3; 43.8; 26.0 | — |
| SECONDARY Percentage of Participants With Dose Discontinuation Due to Adverse Events (AEs) |
2.9; 7.6; 16.0; 0.0; 5.7; 8.0 | — |
| SECONDARY Percentage of Participants With Treatment-Related Serious AEs (SAEs) |
2.9; 3.8; 4.0 | — |
Eligibility Criteria
Inclusion Criteria
- weigh ≥ 40 kg and ≤ 125 kg
- have CHC genotype 1 infection
- has had a liver biopsy or non-invasive liver fibrosis test that shows no evidence of cirrhosis and hepatocellular carcinoma
- must agree that the participant and the participant's partner will each use acceptable methods of contraception for at least 2 weeks prior to Day 1 and continue until at least 6 months after last dose of study medication, or longer if dictated by local regulations (for a female participant who is of childbearing potential or male participant with female sexual partner who is of childbearing potential)
Exclusion Criteria
- participates in any other interventional clinical trial within 30 days of the screening visit in this trial or intends to participate in another interventional clinical trial during participation in this trial
- is co-infected with human immunodeficiency virus (HIV) or hepatitis B virus
- has evidence or history of chronic hepatitis not caused by HCV, including but not limited to nonalcoholic steatohepatitis (NASH), drug-induced hepatitis, and autoimmune hepatitis
- has evidence of decompensated liver disease including, but not limited to, a history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy
- has evidence of hepatocellular carcinoma (HCC) or is under evaluation for HCC
- has evidence of active or suspected malignancy, or a history of malignancy, within the last 5 years
- has been previously treated with an interferon or ribavirin regimen or HCV direct acting anti-viral regimen, or treated for hepatitis C with any investigational medication
- taking/plans to take significant inducers of inhibitors of Cytochrome P450 3A4 (CYP3A4) substrates 2 weeks prior to start of study medications, or herbal supplements, including but not limited to St. John's Wort 2 weeks prior to start of study medications (Day 1)
- has pre-existing psychiatric condition(s)
- has a clinical diagnosis of substance abuse
- has any known medical condition that could interfere with the participation in and completion of the trial including immunologically-mediated disease, chronic pulmonary disease, or current or history of any clinically significant cardiac abnormalities/dysfunction
- is pregnant or nursing (for female participant) or female partner intends to become pregnant (for male participant)
Data sourced from ClinicalTrials.gov (NCT01945294). 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.