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

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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01997944

Enrollment

Registered

2013-11-28

Start date

2013-11-30

Completion date

2014-11-30

Last updated

2014-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis B

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.

Interventions

BIOLOGICALHuman Serum ALbumin/interferon alpha2a

600,750 or 900 mcg dosing every 2 weeks

BIOLOGICALPegasys

180 mcg dosing every week

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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/

Design outcomes

Primary

Measure	Time frame
Number of adverse events	18 weeks

Secondary

Measure	Time frame
AUCss	18 weeks
Css_av	18 weeks
Css_min	18 weeks
Decrease of HBV DNA	18 weeks
T1/2	18 weeks
Tmax	18 weeks
Css-max	18 weeks

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026