- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00964665
Pharmacokinetic/Pharmacodynamic of Albinterferon Alfa-2b in Chronic Hepatitis B, eAg+, Infection Subjects
January 5, 2011 updated by: Novartis Pharmaceuticals
A Pharmacokinetic/Pharmacodynamic Evaluation of ABF656 in Subjects With Chronic Hepatitis B, e Ag+, Infection.
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
141
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Beijing, China
- 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
- Novartis Investigator Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group 1 ABF656 900ug Q2w
|
|
Experimental: Group 2 ABF656 900ug Q4w
|
|
Experimental: Group 3 AB656 1200ug Q4w
|
|
Experimental: Group 4 ABF656 1500ug Q4w
|
|
Active Comparator: Group 5 Pegasys® 180µg qw
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
48 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
up to 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Novartis Pharmaceuticals, Novartis Institute for BioMedical Research
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2009
Primary Completion (Actual)
November 1, 2010
Study Registration Dates
First Submitted
August 24, 2009
First Submitted That Met QC Criteria
August 24, 2009
First Posted (Estimate)
August 25, 2009
Study Record Updates
Last Update Posted (Estimate)
January 6, 2011
Last Update Submitted That Met QC Criteria
January 5, 2011
Last Verified
January 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Hepatitis, Viral, Human
- Hepadnaviridae Infections
- DNA Virus Infections
- Enterovirus Infections
- Picornaviridae Infections
- Hepatitis B
- Hepatitis
- Hepatitis A
- Hepatitis B, Chronic
- Hepatitis, Chronic
- Physiological Effects of Drugs
- Anti-Infective Agents
- Antiviral Agents
- Immunologic Factors
- Interferon-alpha
- Peginterferon alfa-2a
Other Study ID Numbers
- CABF656A2206
- EudraCT 2008-006933-29
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chronic Hepatitis B
-
The Affiliated Nanjing Drum Tower Hospital of Nanjing...Gilead SciencesNot yet recruiting
-
Tongji HospitalGilead SciencesRecruiting
-
Jiangsu HengRui Medicine Co., Ltd.Unknown
-
Changhai HospitalCompleted
-
Tongji HospitalChia Tai Tianqing Pharmaceutical Group Co., Ltd.UnknownChronic Hepatitis b
-
Zhongshan Hospital Xiamen UniversityUnknownHealthy | Chronic Hepatitis B InfectionChina
-
Brii Biosciences LimitedVir Biotechnology, Inc.Active, not recruitingChronic Hepatitis B Virus InfectionSingapore, Thailand, Australia, China, Korea, Republic of
-
Nanfang Hospital of Southern Medical UniversityRecruiting
-
IlDong Pharmaceutical Co LtdRecruitingChronic Hepatitis bKorea, Republic of
Clinical Trials on albinterferon alfa-2b
-
NovartisCompletedChronic Hepatitis CJapan
-
PharmaEssentiaRecruitingPolycythemia VeraUnited States, Canada
-
BiocadCompletedHepatitis | Hepatitis C | Hepatitis C/ Human Immunodeficiency Virus CoinfectionRussian Federation
-
The University of Hong KongRecruitingMyelofibrosis | Primary Myelofibrosis, Prefibrotic StageHong Kong
-
PharmaEssentia Japan K.K.PharmaEssentiaCompleted
-
PharmaEssentiaNot yet recruitingPolycythemia Vera | Myeloproliferative Neoplasm
-
Foundation for Liver ResearchCompletedChronic Hepatitis BNetherlands, China
-
Merck Sharp & Dohme LLCTerminated
-
Third Affiliated Hospital, Sun Yat-Sen UniversityPeking University; Huazhong University of Science and Technology; First People... and other collaboratorsUnknown
-
Xiamen Amoytop Biotech Co., Ltd.Peking University People's HospitalCompletedChronic Hepatitis CChina