A Study of the Effectiveness of Peginterferon Alfa-2a (Pegasys) and Ribavirin Treatment in Slovenian Hepatitis C (HCV) Patients

Completed

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

• Registration Number: NCT02556307
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

In this Slovenian, multi-center, observational study, the effectiveness of standard of care Peginterferon alfa-2a + ribavirin treatment in adult patients with chronic hepatitis C (CHC) is examined. Patients were treated for 24- or 48-weeks, as prescribed by the treating physician, followed by a 24-week follow-up period.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Study First Submitted: 2015-09-21
• Study First Submitted QC: 2015-09-21
• Study First Posted: 2015-09-22
• Status Verified: 2016-01
• Results First Submitted: 2016-01-18
• Results First Submitted QC: 2016-01-18
• Last Update Submitted: 2016-01-18
• Results First Posted: 2016-02-15
• Last Update Posted: 2016-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 270

Inclusion Criteria

• Male and female patients >/= 18 years
• Positive test for HCV
• Effective contraception as specified by the Peginterferon alfa-2a and/or ribavirin labels

Exclusion Criteria

• Concomitant infection with HIV or hepatitis B
• Participation in a clinical trial within 30 days prior to study start
• Any contraindications specified in the Peginterferon alfa-2a and ribavirin product labels

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Peginterferon alfa-2a + Ribavirin	Peginterferon alfa-2a	-
Peginterferon alfa-2a + Ribavirin	Ribavirin	-

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving Sustained Virological Response (SVR) According to Genotype and Previous Treatment	6 months after the last study drug administration (up to 123.6 weeks)	SVR was defined as participants with undetectable Hepatitis C virus (HCV) ribonucleic acid (RNA) at 24 weeks after completion of treatment. Undetectable HCV RNA was defined as a single last HCV RNA less than (\<) 20 international units per milliliter (IU/mL). SVR was evaluated based on HCV genotype (G1, G2, G3 and G4), participant's interleukin 28B genotype (CC, CT and TT), and previous treatment (treatment naive or previous treatment).

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Undetectable HCV RNA	Weeks 4, 12 and at end of treatment (up to 99.6 weeks)	Undetectable HCV RNA=a single last HCV RNA \<20 IU/mL
HCV RNA Values	Baseline; Weeks 4, 12, end of treatment (up to 99.6 weeks) and 6 months after end of treatment (up to 123.6 weeks)
Leukocyte Values	Baseline; Weeks 4, 12, end of treatment (up to 99.6 weeks) and 6 months after end of treatment (up to 123.6 weeks)
Hemoglobin Values	Baseline; Weeks 4, 12, end of treatment (up to 99.6 weeks) and 6 months after end of treatment (up to 123.6 weeks)
Treatment Duration (in Weeks) With Peginterferon Alfa-2a and Ribavirin	Up to 99.6 Weeks
Thrombocyte Values	Baseline; Weeks 4, 12, end of treatment (up to 99.6 weeks) and 6 months after end of treatment (up to 123.6 weeks)