Trial record 113 of 434 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. (see Contacts and Locations)
Verified November 2013 by Beijing Bio-Fortune Ltd.
Sponsor:
Information provided by (Responsible Party):
Beijing Bio-Fortune Ltd.
ClinicalTrials.gov Identifier:
NCT01997944
First received: November 21, 2013
Last updated: November 25, 2013
Last verified: November 2013
  Purpose

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

  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01997944

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

Locations
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.
Investigators
Principal Investigator: Junqi Niu, MD Jilin University First Affiliated Hospital
  More Information

No publications provided

Responsible Party: Beijing Bio-Fortune Ltd.
ClinicalTrials.gov 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
Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Chronic
Hepatitis, Viral, Human
Digestive System Diseases
DNA Virus Infections
Enterovirus Infections
Hepadnaviridae Infections
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Albunex
Interferon-alpha
Interferons
Anti-Infective Agents
Antineoplastic Agents
Antiviral Agents
Contrast Media
Diagnostic Uses of Chemicals
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014