Rate and Predictors of Relapse in the Treatment of Hepatitis C (Study P05181) (FAST-4)
This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
First received: July 25, 2008
Last updated: November 26, 2015
Last verified: November 2015
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.
||Observational Model: Cohort
Time Perspective: Prospective
||Rate and Predictors of Relapse in the Treatment of Hepatitis C in Real-life Clinical Practice in Spanish Hospitals (FAST-4)
Primary Outcome Measures:
- Percentage of Participants With Relapse At 24 Weeks After the End Of Treatment (EOT) [ Time Frame: From enrollment (≤4 weeks after end of treatment) to Week 24 post-treatment ] [ Designated as safety issue: No ]
Relapse rate is defined as the percentage of participants with negative viral load (HCV RNA-) at EOT who have positive viral load (HCV RNA+) at 6 months after EOT.
RNA= Ribonucleic Acid
Secondary Outcome Measures:
- Percentage of Participants Who Relapsed After EOT at Week 72 (Late Relapser) [ Time Frame: From 24 weeks post-treatment to 72 weeks post-treatment ] [ Designated as safety issue: No ]
Late relapse was defined as having a Sustained Viral Response (SVR) at 24 weeks of follow-up and subsequently having a positive viral load 48 weeks later at Week 72.
SVR was defined as negative for HCV RNA at Week 24 of follow-up.
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||April 2010 (Final data collection date for primary outcome measure)
PEG IFN alfa-2b + RBV
Adult participants with chronic hepatitis C who were treated for the first time with pegylated interferon alfa-2b plus ribavirin and achieved end-of-treatment response prior to the study. Participants received no treatment during this study.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Adult subjects with chronic hepatitis C who were treated for the first time with pegylated interferon alfa-2b plus ribavirin and achieved end-of-treatment response.
- 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.
- 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).
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No Contacts or Locations Provided
||Merck Sharp & Dohme Corp.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||July 25, 2008
|Results First Received:
||March 23, 2012
||November 26, 2015
||Spain: Spanish Agency of Medicines
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 02, 2016
Hepatitis C, Chronic
Digestive System Diseases
Hepatitis, Viral, Human
RNA Virus Infections