Skip to main content
OpenTrials
Completed

NCT Number: NCT00723645

Rate and Predictors of Relapse in the Treatment of Hepatitis C (Study P05181)

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hepatitis C, Chronic Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

Rate and Predictors of Relapse in the Treatment of Hepatitis C in Real-life Clinical Practice in Spanish Hospitals (FAST-4)

Acronym: FAST-4

Important dates

Study start
2008
Primary completion
2010
Study completion
2011
First posted
Jul 29, 2008
Registry last updated
Nov 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.