Observational Study Evaluating the Quality of Pegylated Interferon Alfa-2a and Ribavirin Treatment for Chronic Hepatitis C in Cooperation With the BNG (Association of German Resident Gastroenterologists)

Roche

Status: Completed

Conditions: Chronic Hepatitis C

Treatments: Drug: Ribavirin; Drug: Pegylated interferon alfa-2a

Study type: Observational

Funder types: Industry

Identifiers

NCT02106156

ML21645

Details and patient eligibility

About

This observational study will examine the efficacy and safety of pegylated interferon (peginterferon) alfa-2a, mostly in combination with ribavirin treatment in chronic hepatitis C (CHC). Quality of care will also be assessed. Approximately 12% of the interferon-treated CHC patient population in Germany is expected to be studied over a period of 5 years.

Enrollment: 10,228 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years of age or over
• Clinically diagnosed CHC with detectable virus replication
• Women of childbearing potential should use adequate contraception. It is important that female participants of childbearing potential and their sexual partners use 2 contraceptive methods at the same time during treatment and 4 months after treatment discontinuation. During this time pregnancy tests have to be performed monthly. Particular attention is also required and pregnancy should be avoided 7 months after treatment discontinuation in female sexual partners of male participants taking ribavirin (Copegus®). Both should use adequate contraception.

Exclusion criteria

• Any contraindications for peginterferon alfa-2a or ribavirin treatment
• Pregnant or breast-feeding

Trial design

10,228 participants in 1 patient group

Chronic Hepatitis C

Description:

Participants with chronic hepatitis C planned for treatment with peginterferon alfa-2a alone or in combination with ribavirin according to routine clinical practice will be observed in this study.

Treatment:

Drug: Pegylated interferon alfa-2a

Drug: Ribavirin