N/A
Completed N=10,228
Observational Study Evaluating the Quality of Pegylated Interferon Alfa-2a and Ribavirin Treatment for Chronic Hepatitis C in Cooperation With the BNG (Association of German Resident Gastroenterologists)
Chronic Hepatitis C
Source: ClinicalTrials.gov NCT02106156 ↗
Enrolled (actual)
10,228
Serious AEs
4.3%
Results posted
Sep 2016
Primary outcomePrimary: Percentage of Participants With Rapid Virologic Response (RVR) — 40.0; 41.7 percentage of participants
Summary
This observational study will examine the efficacy and safety of pegylated interferon (peginterferon) alfa-2a, mostly in combination with ribavirin treatment in chronic hepatitis C (CHC). Quality of care will also be assessed. Approximately 12% of the interferon-treated CHC patient population in Germany is expected to be studied over a period of 5 years.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Rapid Virologic Response (RVR) |
40.0; 41.7 | — |
| PRIMARY Percentage of Participants With Early Virologic Response (EVR) |
71.2; 77.8 | — |
| PRIMARY Percentage of Participants With End of Treatment (EOT) Response |
59.2; 51.1 | — |
| PRIMARY Percentage of Participants With Sustained Virologic Response (SVR) |
41.4; 36.7 | — |
| PRIMARY Percentage of Participants With Serious Adverse Drug Reactions (SADR) |
3.5; 3.3 | — |
| SECONDARY Percentage Cumulative Dose of Peginterferon Alfa-2a Received |
97.9; 94.8 | — |
| SECONDARY Percentage Cumulative Dose of Ribavirin Received |
100.00; 97.92 | — |
| SECONDARY Duration of Peginterferon Alfa-2a Therapy |
27.3; 29.3 | — |
| SECONDARY Percentage of Participants With the Most Frequent Concomitant Medications |
10.6; 9.9; 5.3; 4.7; 2.3; 2.3 | — |
Eligibility Criteria
Inclusion Criteria
- 18 years of age or over
- Clinically diagnosed CHC with detectable virus replication
- Women of childbearing potential should use adequate contraception. It is important that female participants of childbearing potential and their sexual partners use 2 contraceptive methods at the same time during treatment and 4 months after treatment discontinuation. During this time pregnancy tests have to be performed monthly. Particular attention is also required and pregnancy should be avoided 7 months after treatment discontinuation in female sexual partners of male participants taking ribavirin (Copegus®). Both should use adequate contraception.
Exclusion Criteria
- Any contraindications for peginterferon alfa-2a or ribavirin treatment
- Pregnant or breast-feeding
Data sourced from ClinicalTrials.gov (NCT02106156). 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.