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