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

November 14, 2014 updated by: Beijing Bio-Fortune Ltd.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jilin
      • Changchun, Jilin, China, 130021
        • Jilin University First Affiliated Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female, aged 18-75 years
  • Chronic HBV infection (serum HBsAg detectable for > 6 months)
  • Serum HBeAg positive with HBV DNA >10^6copies/mL (or >20,000 IU/mL),orSerum HBeAg negative with HBV DNA >10^5copies/mL (or >2,000 IU/mL)
  • Serum ALT must be > 2 x ULN but below 10 x ULN

Exclusion Criteria:

  • Steroid treatment or immunosuppression 3 months prior to entry.
  • Interferon therapy or nucleotides analogues therapy in 6 months prior to entry.
  • Active lung disease or history of interstitial lung disease.
  • Hb< LLN or, and ANC < 750/mm3 or , and platelet count < 75,000 mm3 ,or WBC<3000/mm3 .
  • Significant chronic medical conditions other than chronic hepatitis B which in the opinion of the investigator preclude enrollment into the study.
  • Evidence of hepatic decompensation (i.e., Child-Pugh score of B or C).
  • Seropositive for HIV, HCV, or HDV (Hepatitis Delta virus).
  • History of thyroid disease or current treatment for thyroid disease.

Other protocol-defined inclusion/exclusion criteria may apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Human Serum Albumin/interferon alpha2a
Human Serum Albumin/interferon alpha2a 600,750 or 900 mcg multiple dose S.C.
Biological: Human Serum ALbumin/interferon alpha2a
600,750 or 900 mcg dosing every 2 weeks
ACTIVE_COMPARATOR: Pegasys
Peginteferon 180 mcg multiple dose S.C.
Biological: Pegasys
180 mcg dosing every week

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of adverse events
Time Frame: 18 weeks
18 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Decrease of HBV DNA
Time Frame: 18 weeks
18 weeks
AUCss
Time Frame: 18 weeks
18 weeks
Css_av
Time Frame: 18 weeks
18 weeks
Css_min
Time Frame: 18 weeks
18 weeks
Css-max
Time Frame: 18 weeks
18 weeks
T1/2
Time Frame: 18 weeks
18 weeks
Tmax
Time Frame: 18 weeks
18 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Bio-Fortune Ltd.

Investigators

  • Principal Investigator: Junqi Niu, MD, Jilin University First Affiliated Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (ACTUAL)

September 1, 2014

Study Completion (ACTUAL)

November 1, 2014

Study Registration Dates

First Submitted

November 21, 2013

First Submitted That Met QC Criteria

November 25, 2013

First Posted (ESTIMATE)

November 28, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

November 17, 2014

Last Update Submitted That Met QC Criteria

November 14, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 921302

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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