Treatment of Patients With Chronic Hepatitis C With PegIntron as Monotherapy or in Combination With Ribavirin (Study P04437)(COMPLETED) - Full Text View

Sponsored by:	Schering-Plough
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00705666

Purpose

In February 2002, a French Consensus Conference on the management of patients with chronic hepatitis C in France was organized. The jury issued several recommendations on pegylated alpha interferon/ribavirin treatment strategy. Three years after these recommendations, it is of interest to understand the evolution of hepatitis C management in France in real clinical practice. This observational study will permit the identification of patients who are treated and will provide information on the use of PegIntron/ Ribavirin.

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:	Real Situation Observational Study of VIRAFERONPEG® in Patients With Chronic Hepatitis C

Further study details as provided by Schering-Plough:

Primary Outcome Measures:

The proportion of patients receiving the recommended treatment duration (24 weeks for genotypes 2 and 3 and 48 weeks for genotype 1 according to the French 2002 consensus meeting). [ Time Frame: Physicians will complete a questionnaire at these visits: treatment initiation; 12 and 24 weeks after treatment initiation and 24 weeks after the end of treatment; and 36 and 48 weeks after treatment initiation for patients treated for 48 weeks. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To evaluate the proportion of naïve patients, non responders and relapsers at initiation of treatment and the proportion of patients with ALT within the normal range. [ Time Frame: Physicians will complete a questionnaire at these visits: treatment initiation; 12 and 24 weeks after treatment initiation and 24 weeks after the end of treatment; and 36 and 48 weeks after treatment initiation for patients treated for 48 weeks. ] [ Designated as safety issue: No ]
Dose of PegIntron/Rebetol prescribed; treatment management regarding stopping rule recommendations; maintenance therapy regarding patient profile, dose, duration; deviations from Conference Consensus recommendations; impact of reimbursement of the drug. [ Time Frame: Physicians will complete a questionnaire at these visits: treatment initiation; 12 and 24 weeks after treatment initiation and 24 weeks after the end of treatment; and 36 and 48 weeks after treatment initiation for patients treated for 48 weeks. ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	789
Study Start Date:	February 2006
Study Completion Date:	July 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Patients with chronic hepatitis C Adult patients with chronic hepatitis C treated with PegIntron as monotherapy or in combination with ribavirin.	Biological: Peginterferon alfa-2b (SCH 54031) Peginterferon alfa-2b as monotherapy or in combination with ribavirin will be administered according to the products' labeling. Drug: Ribavirin (SCH 18908) Peginterferon alfa-2b as monotherapy or in combination with ribavirin will be administered according to the products' labeling.

Detailed Description:

To assure a good representation of patients treated for hepatitis C, patients who meet the inclusion criteria will be enrolled on a consecutive basis.

Eligibility

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

Study Population

Adult patients with chronic hepatitis C treated with PegIntron as monotherapy or in combination with ribavirin at academic centers, clinics, and private practices in France.

Criteria

Inclusion Criteria:

Adult patients starting a treatment with PegIntron for the treatment of chronic hepatitis C.

Exclusion Criteria:

Concomitant participation in a clinical trial for the treatment of hepatitis C.

Contacts and Locations

No Contacts or Locations Provided

More Information

Responsible Party:	Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers:	P04437
Study First Received:	June 23, 2008
Last Updated:	August 25, 2008
ClinicalTrials.gov Identifier:	NCT00705666
Health Authority:	France: Not Applicable

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