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

This study has been terminated.
Sponsor:
Collaborator:
Human Genome Sciences Inc.
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00964665
First received: August 24, 2009
Last updated: January 5, 2011
Last verified: January 2011
  Purpose

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 Intervention Phase
Chronic Hepatitis B
Drug: albinterferon alfa-2b
Drug: Pegasys®
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pharmacokinetic/Pharmacodynamic Evaluation of ABF656 in Subjects With Chronic Hepatitis B, e Ag+, Infection.

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 141
Study Start Date: July 2009
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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®

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00964665

Locations
China
Novartis Investigator Site
Beijing, China
Hong Kong
Novartis Investigator Site
Sha Tin, Hong Kong
Novartis Investigator Site
Taipo, Hong Kong
Poland
Novartis Investigator Site
Bialystok, Poland
Novartis Investigator Site
Lodz, Poland
Novartis Investigator Site
Warsaw, Poland
Taiwan
Novartis Investigator Site
Kaohsiung, Taiwan
Novartis Investigator Site
Taipei, Taiwan
Novartis Investigator Site
Tau-Yuan County, Taiwan
Thailand
Novartis Investigator Site
Bangkok, Thailand
Novartis Investigator Site
Chiangmai, Thailand
Novartis Investigator Site
Songkla, Thailand
Sponsors and Collaborators
Novartis Pharmaceuticals
Human Genome Sciences Inc.
Investigators
Study Director: Novartis Pharmaceuticals Novartis Institute for Biomedical Research
  More Information

Publications:
Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00964665     History of Changes
Other Study ID Numbers: CABF656A2206, EudraCT 2008-006933-29
Study First Received: August 24, 2009
Last Updated: January 5, 2011
Health Authority: Taiwan: Department of Health
Poland: Ministry of Health
Hong Kong: Department of Health
Thailand: Ministry of Public Health
China: Food and Drug Administration

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

Additional relevant MeSH terms:
Hepatitis
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

ClinicalTrials.gov processed this record on September 16, 2014