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

No publications provided

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 History of Changes
Health Authority:	France: Not Applicable

Study placed in the following topic categories:

Antimetabolites
Interferon-alpha
Liver Diseases
Hepatitis, Chronic
Interferons
Ribavirin
Hepatitis, Viral, Human
Angiogenesis Inhibitors
Antiviral Agents

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
Liver Diseases
Flaviviridae Infections
Hepatitis, Chronic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Ribavirin
Physiological Effects of Drugs
Hepatitis, Viral, Human
Therapeutic Uses
Hepatitis C
Angiogenesis Modulating Agents

Growth Inhibitors
RNA Virus Infections
Growth Substances
Antiviral Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Virus Diseases
Hepatitis
Digestive System Diseases
Peginterferon alfa-2b
Interferon Alfa-2b
Hepatitis C, Chronic

ClinicalTrials.gov processed this record on May 06, 2009