N/A
Completed N=270
A Study of the Effectiveness of Peginterferon Alfa-2a (Pegasys) and Ribavirin Treatment in Slovenian Hepatitis C (HCV) Patients
Hepatitis C, Chronic
Source: ClinicalTrials.gov NCT02556307 ↗
Enrolled (actual)
270
Serious AEs
1.5%
Results posted
Feb 2016
Primary outcomePrimary: Percentage of Participants Achieving Sustained Virological Response (SVR) According to Genotype and Previous Treatment — 66; 51; 67; 75 percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Sustained Virological Response (SVR) According to Genotype and Previous Treatment |
66; 51; 67; 75; 100; 66 | — |
| SECONDARY Percentage of Participants With Undetectable HCV RNA |
64; 21; 79 | — |
| SECONDARY HCV RNA Values |
3281922; 44174; 21342; 39436; 93414 | — |
| SECONDARY Thrombocyte Values |
206; 143; 125; 140; 207 | — |
| SECONDARY Leukocyte Values |
7.0; 3.8; 3.4; 3.6; 7.1 | — |
| SECONDARY Hemoglobin Values |
147; 129; 129; 122; 143 | — |
| SECONDARY Treatment Duration (in Weeks) With Peginterferon Alfa-2a and Ribavirin |
31.0; 31.3 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02556307). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.