drugset / Trial / NCT00351403
Individually Adapted Therapy Duration for the Treatment of Chronic Hepatitis C Genotype 1 Infection
Non-randomizedParallel-groupOpen-labelTreatment
Summary
Patients with chronic hepatitis C genotype 1 virus infection are usually treated with Interferon alfa plus Ribavirin over 48 weeks. For some patients this might be too long, for others too short. An individually adapted therapy length from 24 to 72 weeks will be determined in dependence of the initial virus load and the time to HCV RNA negativity. The primary objective is to compare the cumulative rate of the sustained viral response (SVR) of the patients with the individually adapted therapy duration to the SVR rates of a historic patient collective under the 48 week standard therapy.
Timeline
- Start
- 2006-07
- Primary completion
- 2010-01
- Completion
- 2010-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Peginterferon alfa-2b | Protein / enzyme biologic | 50 ug | Other |
| Subject | Peginterferon alfa-2b | Protein / enzyme biologic | 80 ug | Other |
| Subject | Peginterferon alfa-2b | Protein / enzyme biologic | 100 ug | Other |
| Subject | Peginterferon alfa-2b | Protein / enzyme biologic | 120 ug | Other |
| Subject | Peginterferon alfa-2b | Protein / enzyme biologic | 150 ug | Other |
| Subject | Ribavirin | Small molecule | 200 mg | — |