An Observational Study to Assess the Effect of Cumulative Ribavirin Dose in Participants With Chronic Hepatitis C

NCT ID: NCT02557646

Last Updated: 2016-03-28

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

697 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-05-31

Study Completion Date

2014-03-31

Brief Summary

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The purpose of this open-label, non-randomized, single-arm, multicentre observational study is to investigate the influence of the cumulative dose (total administered dose/ planned dose) of ribavirin on the sustained virologic response (SVR) in participants who have been receiving combination therapy with pegylated interferon alfa-2a (Pegasys) and ribavirin (Copegus).

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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Pegasys + Copegus

Treatment naive participants with confirmed chronic hepatitis C who are started on combined Pegasys-Copegus treatment in accordance with current guidelines and SPCs, and whose treatment has been approved by the Interferon Committee.

Peginterferon alfa-2a

Intervention Type BIOLOGICAL

Participants received pegylated interferon subcutaneous injection in accordance with current guidelines and SPCs.P

Ribavirin

Intervention Type DRUG

Participants received ribavirin 200 mg film-coated tablet in accordance with current guidelines and SPCs.

Interventions

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Peginterferon alfa-2a

Participants received pegylated interferon subcutaneous injection in accordance with current guidelines and SPCs.P

Intervention Type BIOLOGICAL

Ribavirin

Participants received ribavirin 200 mg film-coated tablet in accordance with current guidelines and SPCs.

Intervention Type DRUG

Other Intervention Names

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Pegasys Copegus

Eligibility Criteria

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Inclusion Criteria

* Participants with serologically confirmed chronic hepatitis C
* Participants using and accepting a double method of contraception

Exclusion Criteria

* Participants not approved by the national treatment guideline or the Interferon Committee for combined pegylated interferon-ribavirin treatment
* Contraindications in the summary of product characteristics of pegylated interferon alpha-2a and ribavirin
* Participants previously treated with pegylated interferon and/or ribavirin
* Hepatitis B and Human Immunodeficiency Virus co-infections
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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Ajka, , Hungary

Site Status

Balassagyarmat, , Hungary

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Békéscsaba, , Hungary

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Budapest, , Hungary

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Budapest, , Hungary

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Budapest, , Hungary

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Budapest, , Hungary

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Budapest, , Hungary

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Debrecen, , Hungary

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Debrecen, , Hungary

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Győr, , Hungary

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Gyula, , Hungary

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Kaposvár, , Hungary

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Kecskemét, , Hungary

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Miskolc, , Hungary

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Miskolc, , Hungary

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Nyíregyháza, , Hungary

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Pécs, , Hungary

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Pécs, , Hungary

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Sopron, , Hungary

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Szeged, , Hungary

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Szekszárd, , Hungary

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Székesfehérvár, , Hungary

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Szolnok, , Hungary

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Szombathely, , Hungary

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Tatabánya, , Hungary

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Zalaegerszeg, , Hungary

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Countries

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Hungary

Other Identifiers

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ML22453

Identifier Type: -

Identifier Source: org_study_id

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