An Observational Study of Peginterferon Alfa-2a Plus Ribavirin for Hepatitis C Virus (HCV) Infection in Austria

Completed

• Conditions: Hepatitis C
• Interventions: Drug: Peginterferon alfa-2a; Drug: Ribavirin

• Registration Number: NCT02515279
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This noninterventional, open-label study will observe the safety and tolerability of peginterferon alfa-2a in combination with ribavirin among Austrian participants treated for HCV infection according to routine practice.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Study First Submitted: 2015-07-29
• Study First Submitted QC: 2015-07-31
• Study First Posted: 2015-08-04
• Results First Submitted: 2016-01-12
• Results First Submitted QC: 2016-01-12
• Results First Posted: 2016-02-10
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-10
• Last Update Posted: 2017-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 463

Inclusion Criteria

• Ongoing treatment with peginterferon alfa-2a and ribavirin at the discretion of the prescribing physician
• HCV infection

Exclusion Criteria

• None specified

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants With Hepatitis C	Peginterferon alfa-2a	All participants were treated with Peginterferon alfa-2a+Ribavirin (Pegasys/Copegus) according to the summary of product characteristics and to the investigator's discretion. The daily recommended dose for Pegasys, for the treatment of chronic Hepatitis C, was 180 micrograms once weekly by subcutaneous administration. Copegus was administered orally in doses according to the physician's decision (depending on the participant's weight and genotype). All participants were observed for 12 months.
Participants With Hepatitis C	Ribavirin	All participants were treated with Peginterferon alfa-2a+Ribavirin (Pegasys/Copegus) according to the summary of product characteristics and to the investigator's discretion. The daily recommended dose for Pegasys, for the treatment of chronic Hepatitis C, was 180 micrograms once weekly by subcutaneous administration. Copegus was administered orally in doses according to the physician's decision (depending on the participant's weight and genotype). All participants were observed for 12 months.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Serious Adverse Events (SAEs) and Adverse Events (AEs)	Up to 6 years	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability or incapacity; and congenital anomaly. Percentage of participants with AEs included participants affected with both SAEs and non-SAEs.
Percentage of Participants With End of Treatment Response	12 months	Clinical response to the treatment was measured by qualitative negative polymerase chain reaction (PCR). A participant was considered to have and end of treatment response if there was undetectable Hepatitis C Virus (HCV) ribonucleic acid (RNA) after completing treatment. Participants with available PCR results were reported.
Percentage of Participants With Sustained Virologic Response 24 (SVR24)	18 months	Clinical response to the treatment was measured by qualitative negative polymerase chain reaction (PCR). SVR24 is defined as the percentage of participants with undetectable HCV RNA 24 weeks after completing treatment.

Trial Locations

Locations (1)

A.Ö. Krankenhaus Der Barmherzigen Schwestern Ried; Interne Abtl.; 🇦🇹 Ried-innkreis, Austria