An Observational Study of Peginterferon Alfa-2a in Combination With Ribavirin in Participants With Chronic Hepatitis C and Compensated Liver Cirrhosis (STANDART)

Roche

Status: Completed

Conditions: Hepatitis C, Chronic

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

Study type: Observational

Funder types: Industry

Identifiers

NCT01609049

ML27851

Details and patient eligibility

About

This prospective observational study will evaluate the efficacy and safety of peginterferon alfa-2a in combination with ribavirin in participants with chronic hepatitis C, including participants with compensated liver cirrhosis, in clinical practice.

Enrollment: 1,496 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Serologically confirmed chronic hepatitis C (CHC), hepatitis C virus (HCV) RNA detectable
• Compensated liver cirrhosis (Child-Pugh Class A) included
• Initiating combined therapy with peginterferon alfa-2a and ribavirin

Exclusion criteria

• Human immunodeficiency virus (HIV) co-infection
• Contraindications for combined therapy according to actual prescribing information

Trial design

1,496 participants in 1 patient group

Participants with Chronic Hepatitis C

Description:

Naive and previously treated participants who received peginterferon alfa-2a in combination with ribavirin as per local labeling requirements.

Treatment:

Drug: Ribavirin

Drug: Peginterferon alfa-2a