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

Hepatitis C, Chronic Clinical Trial

— FAST-4  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00723645
• Other study ID #: P05181
• Status: Completed
• Phase: N/A
• First received: July 25, 2008
• Last updated: November 26, 2015
• Start date: April 2008
• Est. completion date: February 2011

Study information

• Verified date: November 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 279
• Est. completion date: February 2011
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Relapse At 24 Weeks After the End Of Treatment (EOT)	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	From enrollment (=4 weeks after end of treatment) to Week 24 post-treatment	No
Secondary	Percentage of Participants Who Relapsed After EOT at Week 72 (Late Relapser)	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.	From 24 weeks post-treatment to 72 weeks post-treatment	No