Recombinant Human Serum Albumin/Interferon alpha2a Fusion Protein Phase Ib Study in Chronic Hepatitis B Patients
NCT ID: NCT01997944
Last Updated: 2014-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
32 participants
INTERVENTIONAL
2013-11-30
2014-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Human Serum Albumin/interferon alpha2a
Human Serum Albumin/interferon alpha2a 600,750 or 900 mcg multiple dose S.C.
Human Serum ALbumin/interferon alpha2a
600,750 or 900 mcg dosing every 2 weeks
Pegasys
Peginteferon 180 mcg multiple dose S.C.
Pegasys
180 mcg dosing every week
Interventions
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Pegasys
180 mcg dosing every week
Human Serum ALbumin/interferon alpha2a
600,750 or 900 mcg dosing every 2 weeks
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Beijing Bio-Fortune Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Junqi Niu, MD
Role: PRINCIPAL_INVESTIGATOR
Jilin University First Affiliated Hospital
Locations
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Jilin University First Affiliated Hospital
Changchun, Jilin, China
Countries
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Other Identifiers
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921302
Identifier Type: -
Identifier Source: org_study_id