drugset / Trial / NCT01740089
Algeron (Cepeginterferon Alfa-2b) Compared With PegIntron (Peginterferon Alfa-2b) for Treatment of Chronic Hepatitis C
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of the study is to demonstrate the noninferiority of Algeron 1.5 and 2.0 μg/kg/week in combination with ribavirin compared to PegIntron in combination with ribavirin in the treatment of chronic hepatitis C, and to determine therapeutic dose of Algeron.
Timeline
- Start
- 2011-11
- Primary completion
- 2012-07
- Completion
- 2013-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CEPEGINTERFERON ALFA-2B | Unknown | 1.5 ug/kg | Subcutaneous |
| Subject | CEPEGINTERFERON ALFA-2B | Unknown | 2 ug/kg | Subcutaneous |
| Comparator | Peginterferon alfa-2b | Protein / enzyme biologic | 1.5 ug/kg | Subcutaneous |
| Background | Ribavirin | Small molecule | 800 mg | Oral |
| Background | Ribavirin | Small molecule | 1000 mg | Oral |
| Background | Ribavirin | Small molecule | 1200 mg | Oral |
| Background | Ribavirin | Small molecule | 1400 mg | Oral |