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

Roche

Status: Completed

Conditions: Hepatitis C, Chronic

Treatments: Drug: Ribavirin; Biological: Peginterferon alfa-2a

Study type: Observational

Funder types: Industry

Identifiers

NCT02557646

ML22453

Details and patient eligibility

About

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).

Enrollment: 697 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

697 participants in 1 patient group

Pegasys + Copegus

Description:

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.

Treatment:

Biological: Peginterferon alfa-2a

Drug: Ribavirin