Back to resultsRecombinant Human Serum Albumin/Interferon alpha2a Fusion Protein Phase Ib Study in Chronic Hepatitis B Patients
Primary Purpose
Chronic Hepatitis B
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Human Serum ALbumin/interferon alpha2a
Pegasys
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Hepatitis B
Eligibility 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
Sites / Locations
- Jilin University First Affiliated Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Human Serum Albumin/interferon alpha2a
Pegasys
Arm Description
Human Serum Albumin/interferon alpha2a 600,750 or 900 mcg multiple dose S.C.
Peginteferon 180 mcg multiple dose S.C.
Outcomes
Primary Outcome Measures
Number of adverse events
Secondary Outcome Measures
Decrease of HBV DNA
AUCss
Css_av
Css_min
Css-max
T1/2
Tmax
Full Information
NCT ID
NCT01997944
First Posted
November 21, 2013
Last Updated
November 14, 2014
Sponsor
Beijing Bio-Fortune Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01997944
Brief Title
Recombinant Human Serum Albumin/Interferon alpha2a Fusion Protein Phase Ib Study in Chronic Hepatitis B Patients
Official Title
Phase Ib Study of Recombinant Human Serum Albumin/Interferon alpha2a Fusion Protein in Chronic Hepatitis B Patients
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
November 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Bio-Fortune Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis B
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Human Serum Albumin/interferon alpha2a
Arm Type
Experimental
Arm Description
Human Serum Albumin/interferon alpha2a 600,750 or 900 mcg multiple dose S.C.
Arm Title
Pegasys
Arm Type
Active Comparator
Arm Description
Peginteferon 180 mcg multiple dose S.C.
Intervention Type
Biological
Intervention Name(s)
Human Serum ALbumin/interferon alpha2a
Intervention Description
600,750 or 900 mcg dosing every 2 weeks
Intervention Type
Biological
Intervention Name(s)
Pegasys
Intervention Description
180 mcg dosing every week
Primary Outcome Measure Information:
Title
Number of adverse events
Time Frame
18 weeks
Secondary Outcome Measure Information:
Title
Decrease of HBV DNA
Time Frame
18 weeks
Title
AUCss
Time Frame
18 weeks
Title
Css_av
Time Frame
18 weeks
Title
Css_min
Time Frame
18 weeks
Title
Css-max
Time Frame
18 weeks
Title
T1/2
Time Frame
18 weeks
Title
Tmax
Time Frame
18 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Junqi Niu, MD
Organizational Affiliation
Jilin University First Affiliated Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jilin University First Affiliated Hospital
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
12. IPD Sharing Statement
Learn more about this trial
Recombinant Human Serum Albumin/Interferon alpha2a Fusion Protein Phase Ib Study in Chronic Hepatitis B Patients
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