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

Chronic Hepatitis B Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00964665
• Other study ID #: CABF656A2206
• Secondary ID: EudraCT 2008-006
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: August 24, 2009
• Last updated: January 5, 2011
• Start date: July 2009

Study information

• Verified date: January 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of HealthPoland: Ministry of HealthHong Kong: Department of HealthThailand: Ministry of Public HealthChina: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 141
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Chronic Hepatitis B
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• albinterferon alfa-2b

• albinterferon alfa-2b

• albinterferon alfa-2b

• albinterferon alfa-2b

• Pegasys®

Locations

Country	Name	City	State
China	Novartis Investigator Site	Beijing
Hong Kong	Novartis Investigator Site	Sha Tin
Hong Kong	Novartis Investigator Site	Taipo
Poland	Novartis Investigator Site	Bialystok
Poland	Novartis Investigator Site	Lodz
Poland	Novartis Investigator Site	Warsaw
Taiwan	Novartis Investigator Site	Kaohsiung
Taiwan	Novartis Investigator Site	Taipei
Taiwan	Novartis Investigator Site	Tau-Yuan County
Thailand	Novartis Investigator Site	Bangkok
Thailand	Novartis Investigator Site	Chiangmai
Thailand	Novartis Investigator Site	Songkla

Sponsors (2)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals	Human Genome Sciences Inc.

Countries where clinical trial is conducted

China,  Hong Kong,  Poland,  Taiwan,  Thailand, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No