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

NCT01997944 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2014-11-17

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

Human Serum ALbumin/interferon alpha2a

600,750 or 900 mcg dosing every 2 weeks

BIOLOGICAL

Pegasys

180 mcg dosing every week

Sponsors & Collaborators

  • Beijing Bio-Fortune Ltd.

    lead INDUSTRY

Principal Investigators

  • Junqi Niu, MD · Jilin University First Affiliated Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2014-09-30
Completion
2014-11-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT01997944 on ClinicalTrials.gov