drugset / Trial / NCT01997944
Recombinant Human Serum Albumin/Interferon alpha2a Fusion Protein Phase Ib Study in Chronic Hepatitis B Patients
RandomizedParallel-groupOpen-labelTreatment
Summary
This is an open label study that will be conducted at a single site in China to evaluate the safety,tolerability and PK/PD profile of multiple dose of recombinant human serum albumin/interferon alpha2a fusion protein in chronic hepatitis B patients.The total duration of study participation is up to 22 weeks for each subject,including 4 weeks screening period.
Timeline
- Start
- 2013-11
- Primary completion
- 2014-09
- Completion
- 2014-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Peginterferon alfa-2a | Protein / enzyme biologic | 180 ug | Subcutaneous |
| Subject | interferon alfa | Protein / enzyme biologic | 600 ug | Subcutaneous |
| Subject | interferon alfa | Protein / enzyme biologic | 750 ug | Subcutaneous |
| Subject | interferon alfa | Protein / enzyme biologic | 900 ug | Subcutaneous |