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

Novartis

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Chronic Hepatitis B

Treatments: Drug: Pegasys®; Drug: albinterferon alfa-2b

Study type: Interventional

Funder types: Industry

Identifiers

NCT00964665

EudraCT 2008-006933-29

CABF656A2206

Details and patient eligibility

About

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.

Enrollment: 141 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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141 participants in 5 patient groups

Group 1 ABF656 900ug Q2w

Experimental group

Treatment:

Drug: albinterferon alfa-2b

Drug: albinterferon alfa-2b

Drug: albinterferon alfa-2b

Drug: albinterferon alfa-2b

Group 2 ABF656 900ug Q4w

Experimental group

Treatment:

Drug: albinterferon alfa-2b

Drug: albinterferon alfa-2b

Drug: albinterferon alfa-2b

Drug: albinterferon alfa-2b

Group 3 AB656 1200ug Q4w

Experimental group

Treatment:

Drug: albinterferon alfa-2b

Drug: albinterferon alfa-2b

Drug: albinterferon alfa-2b

Drug: albinterferon alfa-2b

Group 4 ABF656 1500ug Q4w

Experimental group

Treatment:

Drug: albinterferon alfa-2b

Drug: albinterferon alfa-2b

Drug: albinterferon alfa-2b

Drug: albinterferon alfa-2b

Group 5 Pegasys® 180µg qw

Active Comparator group

Treatment:

Drug: Pegasys®