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

NCT02515279 | Completed Results

• 1 other identifier: ML22273
• Study Type: observational
• Target: 463
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (3)

• Percentage of Participants With Serious Adverse Events (SAEs) and Adverse Events (AEs)

  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

  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)

  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

Study Arms (1)

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; Drug: Ribavirin

Interventions

Peginterferon alfa-2a DRUG

180 micrograms subcutaneous weekly for 48 weeks.

Also known as: Pegasys

Participants With Hepatitis C

Ribavirin DRUG

1000-1600 mg day orally for 48 weeks.

Also known as: Copegus

Participants With Hepatitis C

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• None specified

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

A.Ö. Krankenhaus Der Barmherzigen Schwestern Ried; Interne Abtl.

Ried-innkreis, 4910, Austria

Location

MeSH Terms

Conditions

Hepatitis C

Interventions

peginterferon alfa-2a; Ribavirin

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Limitations and Caveats

The sustained viral response that had to be filled out 6 months (or later) after the end of treatment was documented poorly due to reasons such as participants that were lost to follow-up or the study closure was before the visit date for the SVR.

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-LaRoche

genentech@druginfo.com

800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2015
• First Posted: August 4, 2015
• Study Start: November 1, 2008
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: April 10, 2017
• Results First Posted: February 10, 2016

Record last verified: 2017-03

Locations

AU (1)