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
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Sponsor:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
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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 |
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Hepatitis C, Chronic Hepacivirus | Biological: Peginterferon alfa-2b (SCH 54031) Drug: Ribavirin (SCH 18908) |
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 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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Group/Cohort | Intervention/treatment |
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PegIntron as monotherapy or in combination with Ribavirin.
Adult participants with chronic hepatitis C treated with PegIntron as monotherapy or in combination with ribavirin.
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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 |
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. ]
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
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.
No Contacts or Locations Provided
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 A Hepatitis C Hepatitis C, Chronic Hepatitis Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections |
Flaviviridae Infections Hepatitis, Chronic Ribavirin Peginterferon alfa-2b Interferon-alpha Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents Immunologic Factors Physiological Effects of Drugs |