Phase 2
Completed N=631
Safety and Efficacy of SCH 503034 in Previously Untreated Subjects With Chronic Hepatitis C Infected With Genotype 1 (Study P03523)
Chronic Hepatitis C
Source: ClinicalTrials.gov NCT00423670 ↗
Enrolled (actual)
631
Serious AEs
7.6%
Results posted
Jun 2011
Primary outcomePrimary: Number of Participants With Sustained Virologic Response (SVR) — 39; 58; 58; 69 Participants — p=0.0126
Summary
This was an open-label, randomized safety and efficacy trial in adult, treatment-naïve Chronic Hepatitis C (CHC) participants with genotype 1 infection. The study conducted in 2 parts, compared standard-of-care PegIntron (1.5 μg/kg, once weekly [QW]), plus ribavirin (800 to 1400 mg/day), for 48 weeks to five treatment paradigms containing boceprevir (SCH 503034) 800 mg thrice a day (TID). The five treatments included boceprevir (BOC) plus standard-of-care for 28 or 48 weeks, with and without a 4-week lead-in with PegIntron (PEG) and ribavirin (RBV), and exploration of PegIntron plus low-dose ribavirin (400 to 1000 mg/day) plus boceprevir for 48 weeks.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Sustained Virologic Response (SVR) |
39; 58; 58; 69; 77; 8 | 0.0126 sig |
| SECONDARY Number of Participants With SVR Based on a 4-week lead-in Treatment With PegIntron and Ribavirin |
135; 127 | 0.2864 |
| SECONDARY Number of Participants With SVR Based on Duration of Boceprevir Treatment |
146; 116 | 0.0009 sig |
| SECONDARY Number of Participants Negative for HCV-RNA at FW 12 |
39; 60; 59; 69; 76; 8 | — |
| SECONDARY Number of Participants Negative for HCV-RNA at 72 Weeks Post Randomization |
38; 53; 56; 67; 76; 8 | — |
| SECONDARY Number of Participants With an Early Virologic Response (EVR) That Achieved SVR |
32; 58; 58; 68; 77; 8 | — |
| SECONDARY Number of Participants With a Virologic Response at Follow-up Week 12 That Achieved SVR |
39; 58; 58; 69; 76; 8 | — |
| SECONDARY Number of Participants With a Virologic Response at 72 Weeks Post Randomization That Achieved SVR |
38; 53; 56; 67; 76; 8 | — |
Eligibility Criteria
Inclusion Criteria
- Age between 18 and 60 years;
- Body weight between 45 and 125 kg;
- Documented chronic hepatitis C genotype 1;
- Liver biopsy with histology consistent with chronic hepatitis and no other etiology for chronic liver disease within of 5 years of Day 1;
- Participant and participant's partner(s) must each agree to use acceptable methods of contraception 2 weeks prior to Day 1 and at least 6 months after the last dose of study medication;
- Written informed consent.
Exclusion Criteria
Include, but are not limited to, the following:
- Prior treatment for hepatitis C;
- Co-infection with HIV or hepatitis B virus (HBsAg positive);
- Evidence of decompensated liver disease;
- Diabetic and hypertensive participants with clinically significant ocular exam findings;
- Pre-existing psychiatric condition, including but not limited to:
- Current moderate or severe depression;
- History of depression associated with any of the following:
- Hospitalization for depression;
- Electroconvulsive therapy for depression;
- Depression that resulted in a prolonged absence from work and/or significant disruption of daily functions;
- Suicidal or homicidal ideation and/or attempt;
- History of severe psychiatric disorders (including but not limited to schizophrenia, psychosis, bipolar disorder, post-traumatic stress disorder or mania);
- Past history or current use of lithium;
- Past history or current use of antipsychotic drugs for listed conditions.
- Substance abuse within protocol specified timeframes;
- Pre-existing medical conditions that could interfere with the participant's participation in and completion of the study, including but not limited to chronic pulmonary disease, cardiac dysfunction or immunologically-mediated disease;
- Active or suspected malignancy or history of malignancy within the past 5 years;
- Participants who are pregnant or nursing; participants who intend to become pregnant during the study period. Male participants with partners who are, or intend to become, pregnant during the study period.
- Treatment with any investigational drug or participation in any clinical trial 30 days within Screening;
- Hemoglobin <12 g/dL for females and <13 g/dL for males;
- Neutrophils <1500 mm^3; Blacks: <1200/mm^3;
- Platelets <100,000/mm^3;
- Other clinically significant laboratory test abnormalities.
Data sourced from ClinicalTrials.gov (NCT00423670). 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.