Clinical Trials List
2024-04-30 - 2024-09-12
Phase II
Terminated5
ICD-10B18.1
Chronic viral hepatitis B without delta-agent
ICD-9070.32
Viral hepatitis B without mention of hepatic coma, chronic, without mention of hepatitis delta
A Phase 2a, Open-Label Multiple Dose Study Evaluating the Safety, Tolerability, and Pharmacodynamics of Imdusiran (AB-729) in Combination With Intermittent Dosing of Durvalumab, a PD-L1 Monoclonal Antibody, in Subjects With Chronic HBV Infection
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Trial Applicant
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Sponsor
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Trial scale
Multi-Regional Multi-Center
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Update
2025/11/05
Investigators and Locations
Co-Principal Investigator
- 曾岱宗 Division of General Internal Medicine
- 楊宏志 Division of General Internal Medicine
- Jia-Horng Kao Division of General Internal Medicine
- 蘇東弘 Division of General Internal Medicine
- PEI-JER CHEN Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- Hung-Wei Wang Digestive System Department
- Wei-Fan Hsu Digestive System Department
- Hsueh-Chou Lai Digestive System Department
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 許銘澤 Digestive System Department
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- Chung-Feng Huang Digestive System Department
- Ming-Lung Yu Digestive System Department
- Ming-Lun Yeh Digestive System Department
- Jee-Fu Huang Digestive System Department
- Chia-Yen Dai Digestive System Department
- 梁博程 Digestive System Department
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 吳毅晉 Digestive System Department
- 邱彥程 Digestive System Department
- Hsin-Yu Kuo Digestive System Department
- Chiu Hung Chiu Digestive System Department
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
• Changes in HBV RNA, hepatitis B virus core-associated antigen (HBcrAg), hepatitis B virus surface antibody (HBsAb), and hepatitis B virus e antigen/hepatitis B virus e antibody (HBeAg/HBeAb) (where applicable) since baseline during treatment and follow-up
• Proportion of subjects whose HBsAg changes since baseline at week 48 meet the response criteria (decline of ≤0.5, 1, 2, or 3 log10; ≤lower limit of quantitation [LLOQ]; <100 IU/mL, <10 IU/mL)
• Measurement of PD-L1 receptor occupancy on PBMCs at multiple time points
• Measurement of soluble PD-L1 concentration in plasma at multiple time points
• Measurement of CD4 and CD8 T cell frequencies in blood at multiple time points
• Measurement of soluble immunolabeled concentrations in plasma at multiple time points
• At week 48, the proportion of subjects with ALT < 2 times the upper limit of normal (ULN), HBeAg negative, HBV DNA < LLOQ, and HBsAg < LLOQ was [not specified].
Inclution Criteria
Male or female between the ages of 18-65
Willing and able to provide informed consent
Willing to follow protocol-specified contraception requirement
Exclusion Criteria
Have extensive fibrosis or cirrhosis of the liver
Have or had liver cancer (hepatocellular carcinoma)
Family history or personal history/current thyroid disease on or off replacement therapy
Have a history or current autoimmune disease or has been on immunosuppressive medications within 6 months of the start of the study
Females who are breastfeeding, pregnant or who wish to become pregnant during the study
Known chronic or severe infection or recent significant exposure to infections such as tuberculosis or endemic mycosis, untreated latent infections like tuberculosis, or a positive or indeterminate QuantiFERON test.
The Estimated Number of Participants
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Taiwan
4 participants
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Global
30 participants
