N/A
Completed N=258
Rate and Predictors of Relapse in the Treatment of Hepatitis C (Study P05181)
Hepatitis C, Chronic
Source: ClinicalTrials.gov NCT00723645 ↗
Enrolled (actual)
258
Serious AEs
1.9%
Results posted
Apr 2012
Primary outcomePrimary: Percentage of Participants With Relapse At 24 Weeks After the End Of Treatment (EOT) — 13.65 Percentage of participants
Summary
This is an observational, multicenter, nationwide study where information will be collected on the follow-up of participants with chronic hepatitis C virus (HCV) who have a viral response at the end of treatment with pegylated interferon alfa-2b (PEG IFN alfa-2b) plus ribavirin (RBV) administered according to the directions on the products' labeling. No administration of treatment is planned as a result of study enrollment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Relapse At 24 Weeks After the End Of Treatment (EOT) |
13.65 | — |
| SECONDARY Percentage of Participants Who Relapsed After EOT at Week 72 (Late Relapser) |
0.58 | — |
Eligibility Criteria
Inclusion Criteria
- Participants with chronic hepatitis C virus (HCV)[any genotype] who received pegylated interferon alfa-2b plus ribavirin as first treatment for hepatitis C.
- Negative HCV RNA at the end of treatment (24 or 48 weeks according to the product labeling as appropriate), measured by the assay used at each institution. Only institutions using an assay with a limit of detection of 50 IU/mL or less will be eligible.
Exclusion Criteria
- Women of childbearing potential (i.e., premenopausal women and women who are less than 6 months postmenopausal) who will not use an appropriate contraceptive method during the course of the clinical study. Appropriate contraceptives include double barrier methods (eg, diaphragm or condom plus spermicide), intrauterine device, oral, injectable or subcutaneous hormonal contraceptive, or surgically sterilized partner.
- Completed treatment with pegylated interferon alfa-2b plus ribavirin more than 4 weeks before study entry.
- Positive HCV RNA at the end of treatment (24 or 48 weeks according to the product labeling as appropriate).
- Participants treated for a period shorter than the enrollment period.
- Co-infection with Human Immumodeficiency Virus (HIV).
- Co-infected with Hepatitis B Virus (HBV).
Data sourced from ClinicalTrials.gov (NCT00723645). 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.