Pharmacokinetic/Pharmacodynamic of Albinterferon Alfa-2b in Chronic Hepatitis B, eAg+, Infection Subjects

A Pharmacokinetic/Pharmacodynamic Evaluation of ABF656 in Subjects With Chronic Hepatitis B, e Ag+, Infection.

Status

Terminated

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00964665

Enrollment

141

Registered

2009-08-25

Start date

2009-07-31

Completion date

Unknown

Last updated

2011-01-06

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

Conditions

Chronic Hepatitis B

Keywords

Hepatitis B,, Chronic,, Hepatitis B e Antigens positive

Brief summary

This study will assess the efficacy of ABF656 in chronic hepatitis B characterized by HBeAg positivity. The study is designed to establish a dose response and safety relationship sufficient to allow the subsequent design and conduct of Phase 3 trials. The trial is also designed to generate the PK data in hepatitis B patients to satisfy regulatory requirements in China.

Interventions

DRUGalbinterferon alfa-2b

DRUGPegasys®

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Male or female, aged 18-75 years of either non-child bearing potential or if of child bearing potential on two adequate forms of birth control * Chronic HBV infection (serum HBsAg detectable for \> 6 months) * Serum HBeAg positive with HBV DNA \>106copies/mL (or \>200,000 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. * Chest X-ray with clinically significant active inflammatory process, history of significant pulmonary disease or any history of interstitial lung disease. * Hb\< 10g/dL or, and ANC \< 750/mm3 or , and platelet count \< 75,000 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 hypothyroidism or current treatment for thyroid disease. * Patients with treated or untreated malignancy of any organs, with the exception of localized basal cell carcinoma Other protocol-defined inclusion/

Design outcomes

Primary

Measure	Time frame
Evaluate the safety, tolerability and pharmacodynamic effect of various doses of albinterferon alfa-2b in hepatitis B patients on seroconversion of hepatitis markers. Measure: Clinical laboratory. HBV DNA level and HBeAg seroconversion rate.	48 weeks

Secondary

Measure	Time frame
Evaluate the pharmacokinetics at different doses of albinterferon alfa-2b in patients with chronic hepatitis B infection. Measure: Serum concentration of albinterferon alfa-2b	up to 12 weeks

Countries

China, Hong Kong, Poland, Taiwan, Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026