drugset / Trial / NCT01623336
BIP48 (Peginterferon Alfa 2b 48kDa) Compared With Pegasys® (Peginterferon 2a 40kDa) for Treatment of Chronic Hepatitis C
Phase 2/3
Unknown
740 enrolled
The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
Hospital de Clinicas de Porto Alegre · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of the study is to demonstrate the noninferiority of BIP48 (48 kDa peginterferon alfa-2b) compared to Pegasys ® (40 kDa peginterferon alfa-2a) associated with ribavirin, in naive patients with chronic hepatitis C.
Timeline
- Start
- 2012-01
- Primary completion
- 2016-08
- Completion
- 2016-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BIP48 | Protein / enzyme biologic | 180 ug | Subcutaneous |
| Comparator | Peginterferon alfa-2a | Protein / enzyme biologic | 180 ug | Subcutaneous |