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

Primary Purpose

Chronic Hepatitis B

Status
Terminated
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
albinterferon alfa-2b
albinterferon alfa-2b
albinterferon alfa-2b
albinterferon alfa-2b
Pegasys®
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis B focused on measuring Hepatitis B,, Chronic,, Hepatitis B e Antigens positive

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Group 1 ABF656 900ug Q2w

Group 2 ABF656 900ug Q4w

Group 3 AB656 1200ug Q4w

Group 4 ABF656 1500ug Q4w

Group 5 Pegasys® 180µg qw

Arm Description

Outcomes

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.

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

Full Information

First Posted
August 24, 2009
Last Updated
January 5, 2011
Sponsor
Novartis Pharmaceuticals
Collaborators
Human Genome Sciences Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00964665
Brief Title
Pharmacokinetic/Pharmacodynamic of Albinterferon Alfa-2b in Chronic Hepatitis B, eAg+, Infection Subjects
Official Title
A Pharmacokinetic/Pharmacodynamic Evaluation of ABF656 in Subjects With Chronic Hepatitis B, e Ag+, Infection.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Terminated
Study Start Date
July 2009 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Novartis Pharmaceuticals
Collaborators
Human Genome Sciences Inc.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis B
Keywords
Hepatitis B,, Chronic,, Hepatitis B e Antigens positive

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
141 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1 ABF656 900ug Q2w
Arm Type
Experimental
Arm Title
Group 2 ABF656 900ug Q4w
Arm Type
Experimental
Arm Title
Group 3 AB656 1200ug Q4w
Arm Type
Experimental
Arm Title
Group 4 ABF656 1500ug Q4w
Arm Type
Experimental
Arm Title
Group 5 Pegasys® 180µg qw
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
albinterferon alfa-2b
Intervention Type
Drug
Intervention Name(s)
albinterferon alfa-2b
Intervention Type
Drug
Intervention Name(s)
albinterferon alfa-2b
Intervention Type
Drug
Intervention Name(s)
albinterferon alfa-2b
Intervention Type
Drug
Intervention Name(s)
Pegasys®
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Institute for BioMedical Research
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigator Site
City
Beijing
Country
China
Facility Name
Novartis Investigator Site
City
Sha Tin
Country
Hong Kong
Facility Name
Novartis Investigator Site
City
Taipo
Country
Hong Kong
Facility Name
Novartis Investigator Site
City
Bialystok
Country
Poland
Facility Name
Novartis Investigator Site
City
Lodz
Country
Poland
Facility Name
Novartis Investigator Site
City
Warsaw
Country
Poland
Facility Name
Novartis Investigator Site
City
Kaohsiung
Country
Taiwan
Facility Name
Novartis Investigator Site
City
Taipei
Country
Taiwan
Facility Name
Novartis Investigator Site
City
Tau-Yuan County
Country
Taiwan
Facility Name
Novartis Investigator Site
City
Bangkok
Country
Thailand
Facility Name
Novartis Investigator Site
City
Chiangmai
Country
Thailand
Facility Name
Novartis Investigator Site
City
Songkla
Country
Thailand

12. IPD Sharing Statement

Citations:
PubMed Identifier
12823597
Citation
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. doi: 10.1046/j.1365-2893.2003.00450.x.
Results Reference
background
PubMed Identifier
24995515
Citation
Colvin RA, Tanwandee T, Piratvisuth T, Thongsawat S, Hui AJ, Zhang H, Ren H, Chen PJ, Chuang WL, Sobhonslidsuk A, Li R, Qi Y, Praestgaard J, Han Y, Xu J, Stein DS; ABF656A2206 Study Group. Randomized, controlled pharmacokinetic and pharmacodynamic evaluation of albinterferon in patients with chronic hepatitis B infection. J Gastroenterol Hepatol. 2015 Jan;30(1):184-91. doi: 10.1111/jgh.12671.
Results Reference
derived

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

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