Rate and Predictors of Relapse in the Treatment of Hepatitis C (Study P05181) - Full Text View

Sponsored by:	Schering-Plough
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00723645

Purpose

This is an observational, multicenter, nationwide study where information will be collected on the follow-up of patients with chronic hepatitis C who have a viral response at the end of treatment with peginterferon alfa-2b plus ribavirin (administered according to the directions on the products' labeling). No administration of treatment is planned as a result of study enrollment.

Condition	Intervention
Hepatitis C, Chronic Hepacivirus	Biological: Peginterferon alfa-2b (SCH 54031) Drug: Ribavirin (SCH 18908)

MedlinePlus related topics: Hepatitis Hepatitis C

Drug Information available for: Ribavirin Peginterferon Alfa-2b

U.S. FDA Resources

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

Further study details as provided by Schering-Plough:

Primary Outcome Measures:

Relapse rate in subjects with hepatitis C treated with peginterferon alfa-2b plus ribavirin. Relapse rate is defined as the percentage of patients with negative viral load at end of treatment (EOT) and positive viral load 6 months after EOT. [ Time Frame: Viral load will be determined at post-treatment Follow-up Weeks 24 and 72. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Influence of viral kinetics on relapse rate. Pretreatment factors that predict relapse. Late relapse rate, defined as the percentage of patients with viral response at post-treatment Follow-up Week 24 (SVR) and positive viral load at Follow-up Week 72. [ Time Frame: Viral load will be determined at post-treatment Follow-up Weeks 24 and 72 ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	600
Study Start Date:	April 2008
Estimated Study Completion Date:	February 2010
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Group 1 Adult subjects with chronic hepatitis C who were treated for the first time with peginterferon alfa-2b plus ribavirin and achieved end-of-treatment response.	Biological: Peginterferon alfa-2b (SCH 54031) Information will be collected on the follow-up of patients with chronic hepatitis C who have a viral response at the end of treatment with peginterferon alfa-2b plus ribavirin (administered for 24 or 48 weeks according to the directions on the products' labeling). The treatment period is not part of the study. The study will be conducted during the patient follow-up period after the end of treatment, for up to 72 weeks. Drug: Ribavirin (SCH 18908) Information will be collected on the follow-up of patients with chronic hepatitis C who have a viral response at the end of treatment with peginterferon alfa-2b plus ribavirin (administered for 24 or 48 weeks according to the directions on the products' labeling). The treatment period is not part of the study. The study will be conducted during the patient follow-up period after the end of treatment, for up to 72 weeks.

Groups/Cohorts

Assigned Interventions

Group 1

Adult subjects with chronic hepatitis C who were treated for the first time with peginterferon alfa-2b plus ribavirin and achieved end-of-treatment response.

Biological: Peginterferon alfa-2b (SCH 54031)

Information will be collected on the follow-up of patients with chronic hepatitis C who have a viral response at the end of treatment with peginterferon alfa-2b plus ribavirin (administered for 24 or 48 weeks according to the directions on the products' labeling). The treatment period is not part of the study. The study will be conducted during the patient follow-up period after the end of treatment, for up to 72 weeks.

Drug: Ribavirin (SCH 18908)

Information will be collected on the follow-up of patients with chronic hepatitis C who have a viral response at the end of treatment with peginterferon alfa-2b plus ribavirin (administered for 24 or 48 weeks according to the directions on the products' labeling). The treatment period is not part of the study. The study will be conducted during the patient follow-up period after the end of treatment, for up to 72 weeks.

Detailed Description:

Patient enrollment will be sequential to avoid patient selection bias attributable to the investigator. Each site must enroll 7-8 patients to achieve the calculated sample size so that study objectives can be met.

Patients will be selected by the investigator during the last days of treatment with peginterferon alfa-2b plus ribavirin. Only those patients with a viral response at the end of treatment who sign the informed consent form are eligible.

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 peginterferon alfa-2b plus ribavirin and achieved end-of-treatment response.

Criteria

Inclusion Criteria:

The patient must demonstrate his/her continued willingness to participate in the study.
The patient must be at least 18 years of age, of either gender and of any race.
Patients with chronic hepatitis C (any genotype) who received peginterferon 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 (ie, 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.
Patients who completed treatment with peginterferon alfa-2b plus ribavirin more than 4 weeks before study entry.
Patients with positive HCV-RNA at the end of treatment (24 or 48 weeks according to the product labeling as appropriate).
Patients treated for a period shorter than the enrollment period.
Patients coinfected with HIV.
Patients coinfected with HBV.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00723645

Contacts

Contact: SP Clinical Trial Registry Call Center

1-888-772-8734

Locations

Spain
Coordinating Location	Recruiting
Madrid, Spain

Sponsors and Collaborators

Schering-Plough

More Information

Responsible Party:	Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers:	P05181
Study First Received:	July 25, 2008
Last Updated:	January 14, 2009
ClinicalTrials.gov Identifier:	NCT00723645
Health Authority:	Spain: Spanish Agency of Medicines

Study placed in the following topic categories:

Interferon-alpha
Liver Diseases
Hepatitis, Chronic
Interferons
Ribavirin
Hepatitis, Viral, Human
Hepatitis

Virus Diseases
Digestive System Diseases
Peginterferon alfa-2b
Hepatitis C
Interferon Alfa-2a
Hepatitis C, Chronic
Interferon Alfa-2b

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
RNA Virus Infections
Flaviviridae Infections
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances

Physiological Effects of Drugs
Antiviral Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents

ClinicalTrials.gov processed this record on January 16, 2009