Phase 3
Completed N=282
Safety and Efficacy of Boceprevir in Asia Pacific Participants With Chronic Hepatitis C Genotype 1 (P07063)
Hepatitis C, Chronic
Source: ClinicalTrials.gov NCT01390844 ↗
Enrolled (actual)
282
Serious AEs
7.8%
Results posted
Jun 2016
Primary outcomePrimary: Percentage of Participants in Korea and Taiwan With Sustained Virologic Response (SVR) at Follow-Up Week 24 - Full Analysis Set (FAS) Population — 60.90; 26.15 Percentage of Participants — p=<0.0001
Summary
This study will assess the efficacy of boceprevir (BOC) in combination with PegIntron (pegylated interferon alfa-2b) (PEG) and ribavirin (RBV) in response guided therapy compared to the efficacy of standard-of-care therapy alone in adult subjects with chronic hepatitis C (CHC) genotype 1 who failed prior treatment with pegylated interferon and RBV in the Asia Pacific population. The primary hypothesis is that the proportion of participants achieving sustained virologic response in the experimental therapy regimen (BOC/PEG+RBV) is superior to that in the control arm (Placebo/PEG+RBV), in the Full Analysis Set (FAS) population.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants in Korea and Taiwan With Sustained Virologic Response (SVR) at Follow-Up Week 24 - Full Analysis Set (FAS) Population |
60.90; 26.15 | <0.0001 sig |
| PRIMARY Percentage of Participants in India With SVR at Follow-Up Week 24 - FAS Population |
53.19; 20.83 | 0.0063 sig |
| SECONDARY Percentage of Participants in Korea and Taiwan With SVR at Follow-Up Week 24 - Modified Intent-to-Treat (mITT) Population |
61.83; 26.56 | <0.0001 sig |
| SECONDARY Percentage of Participants in India With SVR at Follow-Up Week 24 - mITT Population |
53.19; 21.74 | 0.0086 sig |
| SECONDARY Percentage of Participants in Korea and Taiwan Achieving Early Virologic Response (EVR) at Treatment Week 8 |
73.68; 44.62 | <0.001 sig |
| SECONDARY Percentage of Participants in India Achieving EVR at Treatment Week 8 |
59.57; 25.00 | 0.004 sig |
| SECONDARY Percentage of Participants With an Adverse Event (AE) of Anemia in Korea and Taiwan |
34.6; 43.1; 29.3; 7.7; 4.5; 0.0 | — |
| SECONDARY Percentage of Participants With an AE of Anemia in India |
25.5; 33.3; 46.8; 8.3; 10.6; 0 | — |
| SECONDARY Percentage of Participants With an AE of Neutropenia in Korea and Taiwan |
30.1; 41.5; 24.8; 20.0; 22.6; 12.3 | — |
| SECONDARY Percentage of Participants With an AE of Neutropenia in India |
51.1; 29.2; 12.8; 4.2; 6.4; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Previously documented CHC genotype 1 infection. Other or mixed genotypes are not eligible.
- Liver biopsy with histology consistent with CHC and no other etiology.
- Participants with cirrhosis must have an ultrasound/imaging study within 6 months of screening (or between screening and Day 1) with no findings suspicious for hepatocellular carcinoma
- Failed previous treatment (of at least 12 weeks) with pegylated interferon (alfa-2a or alfa-2b) plus RBV
- Weight between 40 kg and 125 kg, inclusive
- Of 'local' ancestral descent
- Sexually active males and females of child-bearing potential must agree to use a medically accepted method of contraception
Exclusion Criteria
- Co-infected with the human immunodeficiency virus (HIV) or hepatitis B virus.
- Required discontinuation of previous interferon or RBV regimen for an adverse event considered to be possibly or probably related to RBV and/or interferon.
- Treatment with RBV within 90 days and any interferon-alpha within 1 month prior to screening.
- Treatment for hepatitis C with any investigational medication or prior treatment with herbal remedies with known hepatotoxicity.
- Treatment with any investigational drug or participation in any interventional clinical trial within 30 days of the screening visit.
- Evidence of decompensated liver disease including, but not limited to, a history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy.
- Diabetes and/or hypertension with clinically significant ocular examination findings.
- Any condition the could interfere with participation in and completion of the trial.
- Evidence of active or suspected malignancy, or history of malignancy within the last 5 years (except adequately treatment carcinoma in situ and basal cell carcinoma of the skin).
- Pregnant or breast-feeding.
Data sourced from ClinicalTrials.gov (NCT01390844). 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.