Recombinant Human Serum Albumin/Interferon alpha2a Fusion Protein Phase Ib Study in Chronic Hepatitis B Patients

Beijing Bio-Fortune

Status and phase: Completed; Phase 2; Phase 1

Conditions: Chronic Hepatitis B

Treatments: Biological: Human Serum ALbumin/interferon alpha2a; Biological: Pegasys

Study type: Interventional

Funder types: Industry

Identifiers

NCT01997944

921302

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

Human Serum Albumin/interferon alpha2a

Experimental group

Description:

Human Serum Albumin/interferon alpha2a 600,750 or 900 mcg multiple dose S.C.

Treatment:

Biological: Human Serum ALbumin/interferon alpha2a

Pegasys

Active Comparator group

Description:

Peginteferon 180 mcg multiple dose S.C.

Treatment:

Biological: Pegasys