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Treatment of Patients With Chronic Hepatitis C With PegIntron as Monotherapy or in Combination With Ribavirin (Study P04437)(COMPLETED) (ADEQUATION)

This study has been completed.
Sponsor:
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00705666
First received: June 23, 2008
Last updated: May 27, 2010
Last verified: May 2010
History of Changes
  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)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Real Situation Observational Study of VIRAFERONPEG® in Patients With Chronic Hepatitis C

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Schering-Plough:

Primary Outcome Measures:
  • The Number of Participants 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 participants treated for 48 weeks. ] [ Designated as safety issue: No ]

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
PegIntron as monotherapy or in combination with Ribavirin.
Adult participants 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.
Other Name: PegIntron
Drug: Ribavirin (SCH 18908)
Peginterferon alfa-2b as monotherapy or in combination with ribavirin will be administered according to the products' labeling.
Other Name: Rebetol

Detailed Description:

To assure a good representation of participants treated for hepatitis C, participants 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 participants 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 participants 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: Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier: NCT00705666     History of Changes
Other Study ID Numbers: P04437
Study First Received: June 23, 2008
Results First Received: March 30, 2010
Last Updated: May 27, 2010
Health Authority: France: Not Applicable

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
 Flaviviridae Infections
Ribavirin
Peginterferon alfa-2b
Interferon-alpha
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013