Rate and Predictors of Relapse in the Treatment of Hepatitis C (Study P05181) (FAST-4)
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|ClinicalTrials.gov Identifier: NCT00723645|
Recruitment Status : Completed
First Posted : July 29, 2008
Results First Posted : April 23, 2012
Last Update Posted : November 30, 2015
|Condition or disease|
|Hepatitis C, Chronic|
|Study Type :||Observational|
|Actual Enrollment :||279 participants|
|Official Title:||Rate and Predictors of Relapse in the Treatment of Hepatitis C in Real-life Clinical Practice in Spanish Hospitals (FAST-4)|
|Study Start Date :||April 2008|
|Actual Primary Completion Date :||April 2010|
|Actual Study Completion Date :||February 2011|
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.
- 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 ]
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
- Percentage of Participants Who Relapsed After EOT at Week 72 (Late Relapser) [ Time Frame: From 24 weeks post-treatment to 72 weeks post-treatment ]
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.