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 (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00705666
First received: June 23, 2008
Last updated: April 28, 2014
Last verified: April 2014
  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:


Further study details as provided by Merck Sharp & Dohme Corp.:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
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: April 28, 2014
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 July 28, 2014