Phase 4
Completed N=896
A Study of Induction Dosing With Peginterferon Alfa-2a and Ribavirin in Participants With Chronic Hepatitis C (CHC) Genotype 1 Infection
Hepatitis C, Chronic
Source: ClinicalTrials.gov NCT00192647 ↗
Enrolled (actual)
896
Serious AEs
10.5%
Results posted
Jun 2016
Primary outcomePrimary: Percentage of Participants With Sustained Virological Response According to Scheduled Treatment Period — 53; 50 percentage of participants — p=0.2893
◆ 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 This can indicate results are unpublished — a known publication-bias signal.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 will evaluate the addition of a higher-dose induction treatment period with peginterferon (PEG-IFN) alfa-2a (Pegasys) and ribavirin prior to standard-dose treatment with PEG-IFN alfa-2a and ribavirin, compared to standard-dose treatment, in treatment-naive participants with CHC, genotype 1 infection.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virological Response According to Scheduled Treatment Period |
53; 50 | 0.2893 |
| SECONDARY Percentage of Participants With End-of-Treatment Virological Response According to Scheduled Treatment Period |
70; 66 | — |
| SECONDARY Percentage of Participants With Virological Responses Over Time |
36.0; 26.3; 60.5; 49.8; 74.4; 61.6 | — |
| SECONDARY Percentage of Participants With Relapse of End-of-treatment Virological Response |
24; 22 | — |
| SECONDARY Percentage of Participants With Predictive Values of Virological Response for Sustained Virological Response |
76; 80; 60; 60; 66; 72 | — |
| SECONDARY Change From Baseline in Log10 HCV RNA Values |
6.19; 6.17; -3.42; -2.75; -4.26; -3.68 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of chronic CHC, genotype 1
- Chronic liver disease consistent with CHC on a biopsy sample obtained within the previous 36 months as judged by a local pathologist (all countries except Australia)
- Infection with Hepatitis C virus (Australian sites only had to meet Section 100 criteria for treatment with PEG-IFN alfa-2a plus ribavirin)
- Compensated liver disease
- Naive to interferon-based therapy for CHC infection
Exclusion Criteria
- Systemic antiviral, antineoplastic, or immunomodulatory treatment within 6 months of study drug
- Coinfection with active hepatitis A or B virus, or with human immunodeficiency virus (HIV)
- Chronic liver disease other than CHC infection
Data sourced from ClinicalTrials.gov (NCT00192647). 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.