An Observational Study of Pegasys (Peginterferon Alfa-2a) Plus Ribavirin Based Regimens in Patients With Chronic Hepatitis C With Previous Treatment Failure

NCT ID: NCT01798576

Last Updated: 2016-09-15

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 282 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2015-06-30

Brief Summary

This prospective, national, multicenter, observational study will evaluate in routine clinical practice the efficacy and safety of re-treatment with Pegasys (peginterferon alfa-2a) plus ribavirin or regimens containing direct-acting antivirals in participants with chronic hepatitis C who failed previous treatment. Participants will be followed for the duration of their treatment (24, 48 or 72 weeks) and for 24 weeks of follow-up.

Conditions

Hepatitis C, Chronic

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Pegylated interferon alfa-2a

Participants with chronic hepatitis C with previous treatment failure received combination therapy with pegylated interferon alfa-2a plus ribavirin or treatment regimens containing direct-acting anti-viral (DAAs)

Pegylated Interferon alfa-2a

Intervention Type: DRUG

Dosing was at the discretion of the investigator in accordance with local clinical practice and local labelling.

Ribavirin

Intervention Type: DRUG

Dosing was at the discretion of the investigator in accordance with local clinical practice and local labelling.

Interventions

Pegylated Interferon alfa-2a

Dosing was at the discretion of the investigator in accordance with local clinical practice and local labelling.

Intervention Type: DRUG

Ribavirin

Dosing was at the discretion of the investigator in accordance with local clinical practice and local labelling.

Intervention Type: DRUG

Other Intervention Names

Peginterferon alfa 2A

Eligibility Criteria

Inclusion Criteria

• Adult participants, >/= 18 years of age
• Participants with chronic hepatitis C who have been previously treated with pegylated interferon, standard interferon, ribavirin
• No contra-indications to pegylated interferon and ribavirin therapy or to the treatment regimen containing DAAs as detailed in the local label
• Treatment in line with summary of Product Characteristics/local labeling for Pegasys/ribavirin and DAAs, in particular:

• Positive serum hepatitis C virus (HCV) ribonucleic acid (RNA)
• Fertile males and females receiving ribavirin must use two forms of contraception during treatment with Pegasys/ribavirin and until 6 months post-treatment
• No co-infection with hepatitis B or human immunodeficiency virus (HIV)

Exclusion Criteria

• History or other evidence of a medical condition associated with chronic liver disease other than chronic hepatitis C
• History of neurological disease
• History of severe psychiatric disease
• Decompensated diabetes
• History of immunologically mediated disease
• History of severe cardiac disease
• History or evidence of severe chronic pulmonary disease
• Inadequate hematologic function
• Pregnant or breastfeeding women
• Male partners of pregnant women

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Brasov, , Romania

Countries

Romania

Other Identifiers

ML28498

Identifier Type: -

Identifier Source: org_study_id