Status:
TERMINATED
Pharmacokinetic/Pharmacodynamic of Albinterferon Alfa-2b in Chronic Hepatitis B, eAg+, Infection Subjects
Lead Sponsor:
Novartis Pharmaceuticals
Collaborating Sponsors:
Human Genome Sciences Inc.
Conditions:
Chronic Hepatitis B
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
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 t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
141 Patients enrolled
Trial Details
Trial ID
NCT00964665
Start Date
July 1 2009
Last Update
January 6 2011
Active Locations (12)
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1
Novartis Investigator Site
Beijing, China
2
Novartis Investigator Site
Shatin, Hong Kong
3
Novartis Investigator Site
Taipo, Hong Kong
4
Novartis Investigator Site
Bialystok, Poland