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

Hepatitis C Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02515279
• Other study ID #: ML22273
• Status: Completed
• Phase: N/A
• First received: July 29, 2015
• Last updated: January 12, 2016
• Start date: November 2008
• Est. completion date: December 2014

Study information

• Verified date: January 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: N/A: Local health authority approval not required
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 463
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis C

Intervention

Drug:
• Peginterferon alfa-2a
180 micrograms subcutaneous weekly for 48 weeks.
• Ribavirin
1000-1600 mg day orally for 48 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No