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

March 10, 2017 updated by: Hoffmann-La Roche

A Non-Interventional Trial of Pegasys/Copegus in HCV Patients for 12 Months

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

463

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Ried-innkreis, Austria, 4910
        • A.Ö. Krankenhaus Der Barmherzigen Schwestern Ried; Interne Abtl.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study will enroll Austrian participants receiving peginterferon alfa-2a and ribavirin for HCV infection according to routine practice.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • None specified

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Participants With Hepatitis C
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.
Drug: Peginterferon alfa-2a
180 micrograms subcutaneous weekly for 48 weeks.
Other Names:
  • Pegasys
Drug: Ribavirin
1000-1600 mg day orally for 48 weeks.
Other Names:
  • Copegus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Serious Adverse Events (SAEs) and Adverse Events (AEs)
Time Frame: 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.
Up to 6 years
Percentage of Participants With End of Treatment Response
Time Frame: 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.
12 months
Percentage of Participants With Sustained Virologic Response 24 (SVR24)
Time Frame: 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.
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

July 29, 2015

First Submitted That Met QC Criteria

July 31, 2015

First Posted (Estimate)

August 4, 2015

Study Record Updates

Last Update Posted (Actual)

April 10, 2017

Last Update Submitted That Met QC Criteria

March 10, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML22273

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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