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Clinical Trials List

Protocol NumberAB-729-204

NCT Number(ClinicalTrials.gov Identfier)NCT06277037

Active

2024-03-01 - 2030-03-31

Others

Recruiting6

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 Long-Term Follow-up Study for Subjects with Chronic Hepatitis B Previously Treated with Imdusiran (AB-729)

Trial Applicant
Sponsor

NOVOTECH CLINICAL RESEARCH TAIWAN PTY LTD.
Trial scale

Multi-Regional Multi-Center
Update

2026/02/01

Investigators and Locations

Principal Investigator 陳啟益 Digestive System Department

Chia-Yi Christian Hosptal

Co-Principal Investigator

許銘澤 Digestive System Department

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 羅錦河 Digestive System Department

E-DA Hospital

Co-Principal Investigator

許耀峻 Digestive System Department

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chao-Wei Hsu Digestive System Department

Linkou Chang Gung Medical Foundation

Co-Principal Investigator

Chau-Ting Yeh Digestive System Department
Chen-Chun Lin Digestive System Department
Yi-Cheng Chen Digestive System Department

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 蘇培元 Digestive System Department

CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

楊承達 Digestive System Department
徐友春 Digestive System Department
蘇維文 Digestive System Department
蕭舜文 Digestive System Department

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Wan-Long Chuang

Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

Chung-Feng Huang
梁博程 Digestive System Department
Chia-Yen Dai Digestive System Department
Ming-Lun Yeh Digestive System Department
Jee-Fu Huang
Ming-Lung Yu Digestive System Department

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 呂宜達 Digestive System Department

Taichung Veterans General Hospital

Co-Principal Investigator

林宛姿 Digestive System Department
蔡炘儒 Digestive System Department

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Chronic Hepatitis B (CHB)

Objectives

Evaluate the durability of efficacy of imdusiran on HBV-related parameters.

Test Drug

Imdusiran Injection

Active Ingredient

AB-729 drug substance

Dosage Form

Injecion

Dosage

180 mg/mL

Endpoints

• Concentrations of HBsAg, HBV DNA, HBV RNA, hepatitis B surface antibody (HBsAb), and hepatitis B core-related antigen (HBcrAg) (as applicable), and their changes from the “parent” study baseline and over time.
• Proportion and duration of participants who remain off nucleos(t)ide analogue (NA) therapy, as applicable.
• Proportion of participants who restart NA therapy, as applicable.

Inclution Criteria

Participants will be eligible for inclusion in the study only if all of the following criteria are met:

The participant must:
a. Have previously participated in an imdusiran clinical trial,
b. Have discontinued nucleos(t)ide analogue (NA) therapy in that study,
c. Remain off NA therapy, and
d. Have completed less than 3 years of follow-up visits after NA discontinuation in the parent study.

Be able to review and provide written informed consent, including agreement to comply with all study visit schedules and protocol requirements.

Exclusion Criteria

Not applicable to this study.

The Estimated Number of Participants

Taiwan

16 participants
Global

35 participants