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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


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 DNA








Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.


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

Page last updated: August 23, 2015

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