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:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00705666
First received: June 23, 2008
Last updated: November 5, 2014
Last verified: November 2014
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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
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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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: | November 5, 2014 |
| Health Authority: | France: Not Applicable |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis C Hepatitis C, Chronic Digestive System Diseases Enterovirus Infections Flaviviridae Infections Hepatitis, Chronic Hepatitis, Viral, Human Liver Diseases Picornaviridae Infections RNA Virus Infections |
Virus Diseases Interferon-alpha Peginterferon alfa-2b Ribavirin Anti-Infective Agents Antimetabolites Antiviral Agents Immunologic Factors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Therapeutic Uses |
ClinicalTrials.gov processed this record on February 27, 2015