Phase 4
Completed N=129
A Study of Sustained Virological Response in Relation to IL28-b Expression in Treatment-Naïve Patients With Chronic Hepatitis C Genotype 1 on Combination Treatment With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin)
Hepatitis C, Chronic
Source: ClinicalTrials.gov NCT01447420 ↗
Enrolled (actual)
129
Serious AEs
4.7%
Results posted
Jun 2016
Primary outcomePrimary: Percentage of Participants With Sustained Virological Response Rate in Relation to Interleukin 28B Expression — 63.2; 26.4; 33.3 Percentage of participants — p=0.0007
◆ 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 This can indicate results are unpublished — a known publication-bias signal.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 multi-center, open-label study will evaluate the efficacy and safety of Pegasys (peginterferon alfa-2a) and Copegus (ribavirin) in relation to IL28-b gene expression in treatment-naïve patients with chronic hepatitis C genotype 1. Patients will receive Pegasys (180 mcg sc weekly) and Copegus ( 1'000 or 1'200 mg orally daily) for 48 weeks. Anticipated time of study treatment is 48 weeks, follow-up is 24 weeks.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virological Response Rate in Relation to Interleukin 28B Expression |
63.2; 26.4; 33.3 | 0.0007 sig |
| PRIMARY Percentage of Participants With Incidence of Anemia |
67.4 | — |
| SECONDARY Number of Participants With Viral Response Rate (Rapid/Early/End of Treatment) in Relation to IL28-B Expression |
11; 3; 0; 4; 24; 5 | — |
| SECONDARY Number of Participants With Sustained Virological Response and Occurrence of Anemia During The First Month of Treatment and After the First Month of Treatment |
9; 4; 2; 6; 3; 0 | — |
| SECONDARY Number of Participants With Viral Load Reduction (HCV-RNA Levels) at Week 4 and 12 |
0; 26; 10; 4; 24; 5 | — |
Eligibility Criteria
Inclusion Criteria
- Adult patients, >/=18 and 6
- Hepatocellular carcinoma
- History or evidence of esophageal bleeding
- Hemoglobinopathy, or any other cause for possible hemolysis
- Hb <11 g/dL in women, <12 g/L in males
Data sourced from ClinicalTrials.gov (NCT01447420). 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.