drugset / Trial / NCT00560274
A Study of NeoRecormon (Epoetin Beta) in Anemic Patients With Chronic Hepatitis C.
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This single arm study will assess the safety of NeoRecormon in the correction of anemia in patients with chronic hepatitis C who are being treated with Pegylated interferon + ribavirin combination therapy. Patients will receive NeoRecormon at a starting dose of 30,000 IU s.c. which will be adjusted as required to maintain a target Hb of 11-13g/dL. The anticipated time on study treatment is 1 year, and the target sample size is 100-500 individuals.
Timeline
- Start
- 2008-03
- Primary completion
- 2011-11
- Completion
- 2011-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | epoetin alfa | Protein / enzyme biologic | 30000 iu | Subcutaneous |
| Background | Peginterferon alfa-2a | Protein / enzyme biologic | — | — |
| Background | Ribavirin | Small molecule | — | — |