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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00964665
Recruitment Status : Terminated
First Posted : August 25, 2009
Last Update Posted : January 6, 2011
Human Genome Sciences Inc.
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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.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis B Drug: albinterferon alfa-2b Drug: Pegasys® Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 141 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pharmacokinetic/Pharmacodynamic Evaluation of ABF656 in Subjects With Chronic Hepatitis B, e Ag+, Infection.
Study Start Date : July 2009
Primary Completion Date : November 2010

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U.S. FDA Resources

Arm Intervention/treatment
Experimental: Group 1 ABF656 900ug Q2w Drug: albinterferon alfa-2b
Experimental: Group 2 ABF656 900ug Q4w Drug: albinterferon alfa-2b
Experimental: Group 3 AB656 1200ug Q4w Drug: albinterferon alfa-2b
Experimental: Group 4 ABF656 1500ug Q4w Drug: albinterferon alfa-2b
Active Comparator: Group 5 Pegasys® 180µg qw Drug: Pegasys®

Primary Outcome Measures :
  1. 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. [ Time Frame: 48 weeks ]

Secondary Outcome Measures :
  1. Evaluate the pharmacokinetics at different doses of albinterferon alfa-2b in patients with chronic hepatitis B infection. Measure: Serum concentration of albinterferon alfa-2b [ Time Frame: up to 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00964665

Novartis Investigator Site
Beijing, China
Hong Kong
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
Sponsors and Collaborators
Novartis Pharmaceuticals
Human Genome Sciences Inc.
Study Director: Novartis Pharmaceuticals Novartis Institute for BioMedical Research

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: External Affairs, Novartis Pharmaceuticals Identifier: NCT00964665     History of Changes
Other Study ID Numbers: CABF656A2206
EudraCT 2008-006933-29
First Posted: August 25, 2009    Key Record Dates
Last Update Posted: January 6, 2011
Last Verified: January 2011

Keywords provided by Novartis:
Hepatitis B,
Hepatitis B e Antigens positive

Additional relevant MeSH terms:
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Peginterferon alfa-2a
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs