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

NCT ID: NCT00705666

Last Updated: 2015-10-02

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

789 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-02-28

Study Completion Date

2008-07-31

Brief Summary

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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.

Detailed Description

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To assure a good representation of participants treated for hepatitis C, participants who meet the inclusion criteria will be enrolled on a consecutive basis.

Conditions

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Hepatitis C, Chronic Hepacivirus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Peginterferon alfa-2b (SCH 54031)

Intervention Type BIOLOGICAL

Peginterferon alfa-2b as monotherapy or in combination with ribavirin will be administered according to the products' labeling.

Ribavirin (SCH 18908)

Intervention Type DRUG

Peginterferon alfa-2b as monotherapy or in combination with ribavirin will be administered according to the products' labeling.

Interventions

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Peginterferon alfa-2b (SCH 54031)

Peginterferon alfa-2b as monotherapy or in combination with ribavirin will be administered according to the products' labeling.

Intervention Type BIOLOGICAL

Ribavirin (SCH 18908)

Peginterferon alfa-2b as monotherapy or in combination with ribavirin will be administered according to the products' labeling.

Intervention Type DRUG

Other Intervention Names

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PegIntron Rebetol

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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P04437

Identifier Type: -

Identifier Source: org_study_id

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