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Rate and Predictors of Relapse in the Treatment of Hepatitis C (Study P05181) (FAST-4)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT00723645
First received: July 25, 2008
Last updated: June 19, 2012
Last verified: May 2012
History of Changes
  Purpose

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.


Condition
Hepatitis C, Chronic

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Rate and Predictors of Relapse in the Treatment of Hepatitis C in Real-life Clinical Practice in Spanish Hospitals (FAST-4)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merck:

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.



Enrollment: 279
Study Start Date: April 2008
Study Completion Date: February 2011
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

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).
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck
ClinicalTrials.gov Identifier: NCT00723645     History of Changes
Other Study ID Numbers: P05181
Study First Received: July 25, 2008
Results First Received: March 23, 2012
Last Updated: June 19, 2012
Health Authority: Spain: Spanish Agency of Medicines

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
 Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic

ClinicalTrials.gov processed this record on May 16, 2013