Pharmacokinetic/Pharmacodynamic of Albinterferon Alfa-2b in Chronic Hepatitis B, eAg+, Infection Subjects
NCT ID: NCT00964665
Last Updated: 2011-01-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE1/PHASE2
141 participants
INTERVENTIONAL
2009-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study to Collect Blood Biomarker Samples From Participants With Chronic Hepatitis B (CHB) Who Received Treatment With Pegasys (Peginterferon Alfa-2a) ± Nucleoside/Nucleotide Analogue
NCT01855997
Phase II Trial for Combination Treatment of PEG-Tα1 and Adefovir for HBeAg Positive Chronic Hepatitis B
NCT02366208
A Study of Peginterferon Alfa-2a [PEGASYS] in Patients With Chronic Hepatitis B Who Are HBeAg Positive
NCT01086085
A Study of Peginterferon Alfa-2b Combined With TDF in Patients With Chronic Hepatitis B
NCT04846491
Phase Ⅲ Trial for Combination Treatment of PEG-Tα1 and Adefovir for HBeAg-positive Chronic Hepatitis B
NCT02366247
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group 1 ABF656 900ug Q2w
albinterferon alfa-2b
Group 2 ABF656 900ug Q4w
albinterferon alfa-2b
Group 3 AB656 1200ug Q4w
albinterferon alfa-2b
Group 4 ABF656 1500ug Q4w
albinterferon alfa-2b
Group 5 Pegasys® 180µg qw
Pegasys®
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
albinterferon alfa-2b
albinterferon alfa-2b
albinterferon alfa-2b
albinterferon alfa-2b
Pegasys®
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Human Genome Sciences Inc.
INDUSTRY
Novartis Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Novartis Pharmaceuticals
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Institute for BioMedical Research
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Novartis Investigator Site
Beijing, , China
Novartis Investigator Site
Shatin, , 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 City, , Taiwan
Novartis Investigator Site
Taipei, , Taiwan
Novartis Investigator Site
Tau-Yuan County, , Taiwan
Novartis Investigator Site
Bangkok, , Thailand
Novartis Investigator Site
Chiang Mai, , Thailand
Novartis Investigator Site
Songkhla, , Thailand
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
EudraCT 2008-006933-29
Identifier Type: -
Identifier Source: secondary_id
CABF656A2206
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.