An Observational Study of Peginterferon Alfa-2a Plus Ribavirin for Hepatitis C Virus (HCV) Infection in Austria

NCT ID: NCT02515279

Last Updated: 2017-04-10

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

463 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-11-30

Study Completion Date

2014-12-31

Brief Summary

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This noninterventional, open-label study will observe the safety and tolerability of peginterferon alfa-2a in combination with ribavirin among Austrian participants treated for HCV infection according to routine practice.

Detailed Description

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Conditions

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Hepatitis C

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants With Hepatitis C

All participants were treated with Peginterferon alfa-2a+Ribavirin (Pegasys/Copegus) according to the summary of product characteristics and to the investigator's discretion. The daily recommended dose for Pegasys, for the treatment of chronic Hepatitis C, was 180 micrograms once weekly by subcutaneous administration. Copegus was administered orally in doses according to the physician's decision (depending on the participant's weight and genotype). All participants were observed for 12 months.

Peginterferon alfa-2a

Intervention Type DRUG

180 micrograms subcutaneous weekly for 48 weeks.

Ribavirin

Intervention Type DRUG

1000-1600 mg day orally for 48 weeks.

Interventions

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Peginterferon alfa-2a

180 micrograms subcutaneous weekly for 48 weeks.

Intervention Type DRUG

Ribavirin

1000-1600 mg day orally for 48 weeks.

Intervention Type DRUG

Other Intervention Names

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Pegasys Copegus

Eligibility Criteria

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Inclusion Criteria

* Ongoing treatment with peginterferon alfa-2a and ribavirin at the discretion of the prescribing physician
* HCV infection

Exclusion Criteria

* None specified
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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A.Ö. Krankenhaus Der Barmherzigen Schwestern Ried; Interne Abtl.

Ried-innkreis, , Austria

Site Status

Countries

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Austria

Other Identifiers

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ML22273

Identifier Type: -

Identifier Source: org_study_id

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