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CompletedNCT02557646

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

Status
Completed
Phase
Study type
Observational
Enrollment
697 (actual)
Sponsor
Hoffmann-La Roche · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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).

Conditions

Interventions

TypeNameDescription
BIOLOGICALPeginterferon alfa-2aParticipants received pegylated interferon subcutaneous injection in accordance with current guidelines and SPCs.P
DRUGRibavirinParticipants received ribavirin 200 mg film-coated tablet in accordance with current guidelines and SPCs.

Timeline

Start date
2009-05-01
Primary completion
2014-03-01
Completion
2014-03-01
First posted
2015-09-23
Last updated
2016-03-28
Results posted
2016-02-10

Locations

27 sites across 1 country: Hungary

Source: ClinicalTrials.gov record NCT02557646. Inclusion in this directory is not an endorsement.

An Observational Study to Assess the Effect of Cumulative Ribavirin Dose in Participants With Chronic Hepatitis C (NCT02557646) · Clinical Trials Directory