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

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ClinicalTrials.gov Identifier: NCT00705666
Recruitment Status : Completed
First Posted : June 26, 2008
Results First Posted : June 24, 2010
Last Update Posted : October 2, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease Intervention/treatment
Hepatitis C, Chronic Hepacivirus Biological: Peginterferon alfa-2b (SCH 54031) Drug: Ribavirin (SCH 18908)

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.

Study Design
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Study Type : Observational
Actual Enrollment : 789 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Real Situation Observational Study of VIRAFERONPEG® in Patients With Chronic Hepatitis C
Study Start Date : February 2006
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2008

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U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
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


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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. ]

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

No Contacts or Locations Provided
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00705666     History of Changes
Other Study ID Numbers: P04437
First Posted: June 26, 2008    Key Record Dates
Results First Posted: June 24, 2010
Last Update Posted: October 2, 2015
Last Verified: October 2015

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
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
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs