Phase 3
Completed N=737
Safety and Efficacy of Boceprevir/Peginterferon Alfa-2a/Ribavirin in Interleukin-28B CC Allele-Positive Chronic Hepatitis C Virus (HCV) Genotype 1 Participants (P07755)
Hepatitis C, Chronic
Source: ClinicalTrials.gov NCT01544920 ↗
Enrolled (actual)
737
Serious AEs
8.7%
Results posted
May 2016
Primary outcomePrimary: Percentage of Participants With Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) 24 Weeks After Completing Study Treatment (SVR24) — 86.7; 88.3 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 This can indicate results are unpublished — a known publication-bias signal.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 primary purpose of this study is to compare the efficacy of two boceprevir (BOC)-containing therapeutic regimens in the treatment of naïve participants with chronic hepatitis C virus (HCV) genotype 1 who have the IL28B CC allele.
The regimens differ in the treatment for participants who achieve undetectable HCV ribonucleic acid (RNA) at the end of the peginterferon alfa-2a (peg-IFN) plus ribavirin (RBV) 4 week lead-in. Participants receive either peg-IFN + RBV (Arm 1) or BOC + peg-IFN + RBV (Arm 2). The hypothesis is that Arm 2 is noninferior to Arm 1 in the proportion of participants with undetectable HCV RNA at Follow-Up (FU) Week 24.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) 24 Weeks After Completing Study Treatment (SVR24) |
86.7; 88.3 | — |
| SECONDARY Percentage of Participants Who Had Undetectable HCV RNA at Week 4 Achieving SVR24 |
87.0; 97.2 | — |
Eligibility Criteria
Inclusion Criteria
- Is ≥ 40 kg and ≤ 125 kg.
- Documented CHC genotype 1 with HCV RNA ≥10,000 International Units (IU)/mL
- Has IL-28B CC allele gene
- Has had a liver biopsy without evidence of cirrhosis and hepatocellular carcinoma (non-invasive fibroscan and Fibrotest can also be used for staging of liver disease).
Exclusion Criteria
- Co-infection with the human immunodeficiency virus (HIV) or hepatitis B virus (Hepatitis B surface antigen [HBsAg] or HIV positive).
- Previously treated with an interferon and ribavirin regimen or HCV direct acting antiviral regimen.
- Treatment for hepatitis C with any investigational medication, or prior treatments with herbal remedies with known hepatotoxicity
- Receiving any medication(s) within 2 weeks prior to the Day 1 visit that are highly dependent on Cytochrome P450 3A4 (CYP3A4/5) for clearance, and for which elevated plasma concentrations could be associated with serious and/or life-threatening events
- Participation in any other clinical trial within 30 days of the screening visit in this trial or intention to participate in another clinical trial during participation in this trial.
- Evidence of decompensated liver disease or hepatocellular carcinoma (HCC)
- Is diabetic and/or hypertensive with significant retinopathy
- 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.
- Evidence of active or suspected malignancy, or a history of malignancy, within the last 5 years
- Hemoglobin 1.5 x upper limit of normal (ULN) of the laboratory reference range.
Data sourced from ClinicalTrials.gov (NCT01544920). 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.