Trial record 110 of 445 for:    hepatitis b | Open Studies

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

This study is currently recruiting participants.
Verified November 2013 by Beijing Bio-Fortune Ltd.
Information provided by (Responsible Party):
Beijing Bio-Fortune Ltd. Identifier:
First received: November 21, 2013
Last updated: November 25, 2013
Last verified: November 2013

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.

Condition Intervention Phase
Chronic Hepatitis B
Biological: Human Serum ALbumin/interferon alpha2a
Biological: Pegasys
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase Ib Study of Recombinant Human Serum Albumin/Interferon alpha2a Fusion Protein in Chronic Hepatitis B Patients

Resource links provided by NLM:

Further study details as provided by Beijing Bio-Fortune Ltd.:

Primary Outcome Measures:
  • Number of adverse events [ Time Frame: 18 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Decrease of HBV DNA [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
  • AUCss [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
  • Css_av [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
  • Css_min [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
  • Css-max [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
  • T1/2 [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
  • Tmax [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: November 2013
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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

  Contacts and Locations
Please refer to this study by its identifier: NCT01997944

Contact: Yanhua Ding, MD +86-431-88782168
Contact: Junqi Niu, MD +96-431-88782168

China, Jilin
Jilin University First Affiliated Hospital Recruiting
Changchun, Jilin, China, 130021
Contact: Yanhua Ding, MD    +86-431-88782168      
Principal Investigator: Yanhua Ding, MD         
Sponsors and Collaborators
Beijing Bio-Fortune Ltd.
Principal Investigator: Junqi Niu, MD Jilin University First Affiliated Hospital
  More Information

No publications provided

Responsible Party: Beijing Bio-Fortune Ltd. Identifier: NCT01997944     History of Changes
Other Study ID Numbers: 921302
Study First Received: November 21, 2013
Last Updated: November 25, 2013
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Hepatitis A
Hepatitis B
Hepatitis, Chronic
Hepatitis B, Chronic
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Interferon Alfa-2a
Peginterferon alfa-2a
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents processed this record on April 15, 2014