Clinical Trials List
2014-12-01 - 2016-12-31
Others
Terminated12
ICD-10B18.1
Chronic viral hepatitis B without delta-agent
A Phase IIB-III, open-label, randomized, comparative study to assess the efficacy of ABX203 to maintain control of Hepatitis B disease after cessation of treatment with nucleos(t)ide analogs in adult HBeAg negative patients with chronic Hepatitis B in the Asia Pacific region
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Trial Applicant
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Sponsor
ABIVAX SA
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- 陳介章 Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 紀廣明 Digestive System Department
- 李全膜 Digestive System Department
- 陳建宏 Digestive System Department
- Jing-Houng Wang Digestive System Department
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 林志郎 Digestive System Department
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 陳昇弘 Digestive System Department
- Hung-Yao Chen Digestive System Department
- Hsueh-Chou Lai Digestive System Department
- 蘇文邦 Digestive System Department
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Wei-Yu Kao Digestive System Department
- 方聖惟 Digestive System Department
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 何建興 Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 吳立偉 Digestive System Department
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Chia-Yen Dai Digestive System Department
- Ming-Lung Yu Digestive System Department
- Ming-Lun Yeh Digestive System Department
- Jee-Fu Huang Digestive System Department
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 楊宏志 Digestive System Department
- 蘇東弘 Digestive System Department
- Chun-Jen Liu Digestive System Department
The Actual Total Number of Participants Enrolled
0 Terminated
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
1.75
Endpoints
1. Percentage of subjects with viral load < 40 IU/mL at Week 48. [ Time Frame: Week 48 ]
Secondary Outcome Measures :
1. Clinical response defined as changes in viral load, liver function, time to relapse [ Time Frame: Week 48 and Week 96 ]
2. Immune response defined as T-cell response by ICS (CD4 and CD8 to HBcAg and HBsAg) [ Time Frame: Week 48 ]
3. Safety assessment will be conducted throughout the study and will include physical examinations, vital signs, clinical laboratory évaluations, and the recording of AEs [ Time Frame: Participants will be followed for the duration of their study participation up to 96 weeks ]
Inclution Criteria
• Male or female subject between 18 and 65 years of age at the time of randomization.
• Must be HBeAg negative and anti-HBe Abs positive for at least 1 year prior to screening and at screening.
• Has HBV DNA < 40 IU/mL for at least 1 year prior to screening and at screening
• Has both ALT and AST levels ≤ ULN for at least 1 year prior to screening and at screening.
• Must be HBsAg positive at screening.
• Has been treated with NUCs for at least 2 years prior to screening.
• Has not been treated with PEG-IFN or IFN for at least 1 year prior to screening.
• For all females, must have a negative serum pregnancy test at screening. For female of childbearing potential, must have been using adequate contraception and must agree to continue to use it during all study period and for 6 months after completion of the study product administration.
• Has provided written informed consent.
Exclusion Criteria
• Has elevated blood levels of alpha-fetoprotein (AFP) (> 500 ng/mL).
• Has cirrhosis, defined as
o platelet count < 150,000/mm3, with esophageal varices on imaging and spleen size > 12, or
o liver stiffness of 11 kilopascal [kPa] as measured by elastography using FibroScan® or .an AST to Platelet Ratio Index (APRI) > 2).
• Has hepatocellular carcinoma (HCC) (diagnosed by ultrasonography).
• Has liver decompensation (albumin < 3.5 g/dL and bilirubin ≥1.3 mg/dL).
• Is Hepatitis C virus (HCV) Ab positive at screening.
• Is Hepatitis delta virus (HDV) Ab positive at screening.
• Is Human Immunodeficiency Virus (HIV) Ab positive at screening.
• Has an immune suppressive disorder or treatment with immunosuppressive drugs.
• Has been treated with corticosteroids within 12 weeks prior to the first administration of study product, with the exception of topical or inhaled corticosteroids.
• Has been treated with rituximab.
• Has other hepatic diseases of different etiology (such as auto-immune hepatitis, toxic hepatitis, Wilson disease, alcoholic or hemochromatosis).
• Has a history of allergic disease or reactions likely to be exacerbated by any component of the study products.
• Has a history of a substance abuse (drug or alcohol) problem within the previous 3 years.
The Estimated Number of Participants
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Taiwan
50 participants
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Global
234 participants
