Recombinant Human Serum Albumin/Interferon alpha2a Fusion Protein Phase Ib Study in Chronic Hepatitis B Patients
Information source: Beijing Bio-Fortune Ltd.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Hepatitis B
Intervention: Human Serum ALbumin/interferon alpha2a (Biological); Pegasys (Biological)
Phase: Phase 1/Phase 2
Status: Completed
Sponsored by: Beijing Bio-Fortune Ltd. Official(s) and/or principal investigator(s): Junqi Niu, MD, Principal Investigator, Affiliation: Jilin University First Affiliated Hospital
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.
Clinical Details
Official title: Phase Ib Study of Recombinant Human Serum Albumin/Interferon alpha2a Fusion Protein in Chronic Hepatitis B Patients
Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Number of adverse events
Secondary outcome: Decrease of HBV DNAAUCss Css_av Css_min Css-max T1/2 Tmax
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
Locations and Contacts
Jilin University First Affiliated Hospital, Changchun, Jilin 130021, China
Additional Information
Starting date: November 2013
Last updated: November 14, 2014
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