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

Phase 1

Terminated

• Conditions: Chronic Hepatitis B
• Interventions: Drug: albinterferon alfa-2b; Drug: Pegasys®

• Registration Number: NCT00964665
• Lead Sponsor: Novartis Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-08-24
• Study First Submitted QC: 2009-08-24
• Study First Posted: 2009-08-25
• Primary Completion: 2010-11
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-05
• Last Update Posted: 2011-01-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 141

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 4 ABF656 1500ug Q4w	albinterferon alfa-2b	-
Group 5 Pegasys® 180µg qw	Pegasys®	-
Group 1 ABF656 900ug Q2w	albinterferon alfa-2b	-
Group 2 ABF656 900ug Q4w	albinterferon alfa-2b	-
Group 3 AB656 1200ug Q4w	albinterferon alfa-2b	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Novartis Investigator Site; 🇹🇭 Songkla, Thailand