A Study of Predictors of the Effectiveness of Pegylated Interferon in a Cohort of Participants With Hepatitis C

NCT ID: NCT01659567

Last Updated: 2017-10-03

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

516 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-04-06

Study Completion Date

2015-10-20

Brief Summary

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This prospective observational study will investigate predictive values of virological response in pegylated interferon alfa-2a (Pegasys)/ribavirin (Copegus) treatment-naive participants with chronic hepatitis C. Participants will be treated with pegylated interferon alfa-2a and ribavirin as prescribed by the physician. Data will be collected for a maximum of 96 weeks.

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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Chronic Hepatitis C

Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (Copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, will be observed for up to 96 weeks.

Pegylated Interferon Alfa-2a

Intervention Type DRUG

Pegylated interferon alfa-2a will be administered according to the current standard of care and in line with current summaries of product characteristics/local labelling.

Ribavirin

Intervention Type DRUG

Ribavirin will be administered according to the current standard of care and in line with current summaries of product characteristics/local labelling.

Interventions

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Pegylated Interferon Alfa-2a

Pegylated interferon alfa-2a will be administered according to the current standard of care and in line with current summaries of product characteristics/local labelling.

Intervention Type DRUG

Ribavirin

Ribavirin will be administered according to the current standard of care and in line with current summaries of product characteristics/local labelling.

Intervention Type DRUG

Other Intervention Names

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Pegasys Copegus

Eligibility Criteria

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Inclusion Criteria

\- Diagnosis of chronic hepatitis C infection

Exclusion Criteria

* Co-infection with human immunodeficiency virus (HIV) and/or hepatitis B
* Participants previously treated with pegylated interferon alfa-2a/ribavirin
* Participation in another clinical study within 30 days prior to study start of ML25544
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Hepatology Clinic Hepa

Tbilisi, , Georgia

Site Status

Infectious Diseases, AIDS and Clinical Immunology Research Center

Tbilisi, , Georgia

Site Status

Ltd Mrcheveli

Tbilisi, , Georgia

Site Status

Countries

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Georgia

Other Identifiers

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ML25544

Identifier Type: -

Identifier Source: org_study_id