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

Information source: Novartis
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Hepatitis B

Intervention: albinterferon alfa-2b (Drug); albinterferon alfa-2b (Drug); albinterferon alfa-2b (Drug); albinterferon alfa-2b (Drug); Pegasys® (Drug)

Phase: Phase 1/Phase 2

Status: Terminated

Sponsored by: Novartis Pharmaceuticals

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Institute for Biomedical Research


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.

Clinical Details

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

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: 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.

Secondary outcome: Evaluate the pharmacokinetics at different doses of albinterferon alfa-2b in patients with chronic hepatitis B infection. Measure: Serum concentration of albinterferon alfa-2b


Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.


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/exclusion criteria may apply

Locations and Contacts

Novartis Investigator Site, Beijing, China

Novartis Investigator Site, Sha Tin, Hong Kong

Novartis Investigator Site, Taipo, Hong Kong

Novartis Investigator Site, Bialystok, Poland

Novartis Investigator Site, Lodz, Poland

Novartis Investigator Site, Warsaw, Poland

Novartis Investigator Site, Kaohsiung, Taiwan

Novartis Investigator Site, Taipei, Taiwan

Novartis Investigator Site, Tau-Yuan County, Taiwan

Novartis Investigator Site, Bangkok, Thailand

Novartis Investigator Site, Chiangmai, Thailand

Novartis Investigator Site, Songkla, Thailand

Additional Information

Related publications:

Cooksley WG, Piratvisuth T, Lee SD, Mahachai V, Chao YC, Tanwandee T, Chutaputti A, Chang WY, Zahm FE, Pluck N. Peginterferon alpha-2a (40 kDa): an advance in the treatment of hepatitis B e antigen-positive chronic hepatitis B. J Viral Hepat. 2003 Jul;10(4):298-305.

Starting date: July 2009
Last updated: January 5, 2011

Page last updated: August 20, 2015

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