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

NCT03294798 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2021-04-01

No results posted yet for this study

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.

Conditions

  • Hepatitis B Virus

Interventions

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.

Sponsors & Collaborators

  • Tianjin SinoBiotech Ltd.

    lead INDUSTRY

Principal Investigators

  • meixia wang, professor · Beijing YouAn Hospital

  • jun li, professor · The First Affiliated Hospital with Nanjing Medical University

  • liang chen, professor · Shanghai Public Health Clinical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-13
Primary Completion
2019-03-15
Completion
2021-03-15

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03294798 on ClinicalTrials.gov