NCT03294798

Study of Recombinant Human Serum Albumin/Interferon alpha2b Fusion Protein in Hepatitis B Patient

Evaluate the Pharmacokinetic and Pharmacodynamic Profile, Safety, and Tolerability of Escalating Single Dose & Multiple Dose by Using Recombinant Human Serum Albumin/Interferon alpha2b Fusion Protein in Hepatitits B Patients

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Tianjin SinoBiotech Ltd. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the dosages of recombinant human serum albumin/interferon alpha2b fusion protein injection on HBV subjects. The secondary purposes is to get the PK/PD data in recombinant human serum albumin/interferon alpha2b fusion protein injection on HBV subjects.

Detailed description

This is an open-label study that will be conducted at three sites in China to characterize the PK/PD profile, safety and tolerability of Recombinant Human Serum Albumin/interferon alpha2b Fusion Protein in HBV subjects. Subjects will receive a single dose of Recombinant Human Serum Albumin/interferon alpha2b Fusion Protein or active comparator Pegasys at Day 0. A multipule-dose administration in HBV subjects will last 12 weeks after four weeks washout period.

Conditions

• Hepatitis B Virus

Interventions

Type	Name	Description
BIOLOGICAL	Human Serum Albumin/interferon alpha2b fusion protein	In experiemental groups, each subject will recieve 600,750,900mg once per two weeks during multiple dose period.
BIOLOGICAL	Pegasys	In comparator group, each subject will recieve 180mcg once per week.

Timeline

• Start date: 2017-06-13
• Primary completion: 2019-03-15
• Completion: 2021-03-15
• First posted: 2017-09-27
• Last updated: 2021-04-01

Locations

1 site across 1 country: China