drugset / Trial / NCT01997944

Recombinant Human Serum Albumin/Interferon alpha2a Fusion Protein Phase Ib Study in Chronic Hepatitis B Patients

NCT01997944

Phase 1/2 Completed 32 enrolled Beijing Bio-Fortune Ltd.
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

EvaluationDrugModalityDoseRoute
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