Rate and Predictors of Relapse in the Treatment of Hepatitis C (Study P05181)

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

279 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-04-30

Study Completion Date

2011-02-28

Brief Summary

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This is an observational, multicenter, nationwide study where information will be collected on the follow-up of participants with chronic hepatitis C virus (HCV) who have a viral response at the end of treatment with pegylated interferon alfa-2b (PEG IFN alfa-2b) plus ribavirin (RBV) administered according to the directions on the products' labeling. No administration of treatment is planned as a result of study enrollment.

Detailed Description

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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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PEG IFN alfa-2b + RBV

Adult participants with chronic hepatitis C who were treated for the first time with pegylated interferon alfa-2b plus ribavirin and achieved end-of-treatment response prior to the study. Participants received no treatment during this study.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Participants with chronic hepatitis C virus (HCV)\[any genotype\] who received pegylated interferon alfa-2b plus ribavirin as first treatment for hepatitis C.
* Negative HCV RNA at the end of treatment (24 or 48 weeks according to the product labeling as appropriate), measured by the assay used at each institution. Only institutions using an assay with a limit of detection of 50 IU/mL or less will be eligible.

Exclusion Criteria

* Women of childbearing potential (i.e., premenopausal women and women who are less than 6 months postmenopausal) who will not use an appropriate contraceptive method during the course of the clinical study. Appropriate contraceptives include double barrier methods (eg, diaphragm or condom plus spermicide), intrauterine device, oral, injectable or subcutaneous hormonal contraceptive, or surgically sterilized partner.
* Completed treatment with pegylated interferon alfa-2b plus ribavirin more than 4 weeks before study entry.
* Positive HCV RNA at the end of treatment (24 or 48 weeks according to the product labeling as appropriate).
* Participants treated for a period shorter than the enrollment period.
* Co-infection with Human Immumodeficiency Virus (HIV).
* Co-infected with Hepatitis B Virus (HBV).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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P05181

Identifier Type: -

Identifier Source: org_study_id