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Post Marketing Observational Study of Retreatment of Chronic Hepatitis C With Peginterferon Alpha and Ribavirin (Study P06011)

NCT ID: NCT01098097

Last Updated: 2014-11-26

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

963 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-06-30

Study Completion Date

2011-10-31

Brief Summary

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To study retreatment in patients who failed prior treatment with interferon alpha (pegylated or non-pegylated) with or without ribavirin in a real-life setting in an observational/noninterventional study.

Detailed Description

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This is an observational/non interventional study to collect data on the patient characteristics of those seeking retreatment as well as safety and efficacy information during the first 12 weeks of retreatment.

Conditions

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Hepatitis C, Chronic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Peginterferon alpha and ribavirin

Peginterferon alpha and ribavirin will be administered at the discretion of the treating physician, in accordance per label according to local guidelines for all participating countries.

Peginterferon alpha

Intervention Type BIOLOGICAL

Peginterferon alpha given in combination with ribavirin according to local labeling guidelines

Ribavirin

Intervention Type DRUG

Ribavirin given in combination with peginterferon alpha according to local labeling guidelines

Interventions

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Peginterferon alpha

Peginterferon alpha given in combination with ribavirin according to local labeling guidelines

Intervention Type BIOLOGICAL

Ribavirin

Ribavirin given in combination with peginterferon alpha according to local labeling guidelines

Intervention Type DRUG

Other Intervention Names

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PegIntron SCH 054031 MK-4031 Rebetol SCH 018908 MK-8908

Eligibility Criteria

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Inclusion Criteria

* Chronic hepatitis C of any genotype;
* Prior treatment with interferon alpha (pegylated or non-pegylated) with or without ribavirin did not result in a sustained virological response;
* Willingness of the patient to participate and sign the Informed Consent Form.

Exclusion Criteria

* Patient exclusion from this observational/non-interventional study will be determined by the treating physician and will be based on the local label in each country.
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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P06011

Identifier Type: -

Identifier Source: org_study_id