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Clinical Trials List

Protocol NumberGS-US-642-5670

NCT Number(ClinicalTrials.gov Identfier)NCT05770895

Completed

2023-02-15 - 2025-06-30

Phase I

Terminated10

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 1a/1b Study to Evaluate the Safety and Tolerability of Repeated Doses of Nonreplicating Arenavirus Vector Therapeutic Vaccines GS-2829 and GS-6779 in Healthy Participants and Participants With Chronic Hepatitis B (CHB)

Trial Applicant

GILEAD SCIENCES HONG KONG LIMITED
Sponsor
Trial scale

Multi-Regional Multi-Center
Update

2026/02/01

Investigators and Locations

Principal Investigator 許耀峻 Digestive System Department

E-DA Hospital

Co-Principal Investigator

曾政豪 Digestive System Department
陳子皓 Digestive System Department
戴啟明 Digestive System Department
吳翊綝 Digestive System Department
蔡英楠 Digestive System Department

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 羅清池 Digestive System Department

St. Martin De Porres Hospital

Co-Principal Investigator

黃國智 Digestive System Department
林建宏 Digestive System Department
蕭伯諺 Digestive System Department
鄭旭盛 Digestive System Department
廖義堂 Digestive System Department

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Sheng-Shun Yang Digestive System Department

Taichung Veterans General Hospital

Co-Principal Investigator

林宛姿 Digestive System Department
TENG-YU LEE Digestive System Department
蔡炘儒 Digestive System Department
李少武 Digestive System Department
呂宜達 Digestive System Department
CHUNG-HSIN CHANG Digestive System Department

The Actual Total Number of Participants Enrolled

0 Terminated

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 Terminated

Principal Investigator 曾國枝 Digestive System Department

Dalin Tzu Chi Hospital Buddhist Tzu Chi Medical Foundation

Co-Principal Investigator

曾志偉 Digestive System Department
陳彥均 Digestive System Department
柯秉宏 Digestive System Department

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 蘇東弘 Digestive System Department

National Taiwan University Hospital

Co-Principal Investigator

Jia-Horng Kao Digestive System Department
廖思涵 Digestive System Department
Shih-Jer Hsu Digestive System Department
楊宏志 Digestive System Department
洪俊銘 Digestive System Department
曾岱宗 Digestive System Department
Chen-Hua Liu Digestive System Department
PEI-JER CHEN Digestive System Department
Chun-Jen Liu Digestive System Department

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 胡琮輝 Digestive System Department

Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

Jing-Houng Wang Digestive System Department
黃寳源 Digestive System Department
張國欽 Digestive System Department
紀廣明 Digestive System Department
趙景華 Digestive System Department

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Wen-Juei Jeng Digestive System Department

Linkou Chang Gung Medical Foundation

Co-Principal Investigator

Chun-Yen Lin Digestive System Department
Chien-Hao Huang Digestive System Department
鄭雅婷 Digestive System Department
林伯庭 Digestive System Department
Yi-Cheng Chen Digestive System Department
Rong-Nan Chien Digestive System Department
I-Shyan Sheen Digestive System Department
陳正仁 Digestive System Department
滕威 Digestive System Department
Yi-Chung Hsieh Digestive System Department
Chao-Wei Hsu Digestive System Department
劉彦君 Digestive System Department
戴達英 Digestive System Department

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Ming-Lung Yu Digestive System Department

Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

Chung-Feng Huang Digestive System Department
Jee-Fu Huang Digestive System Department
Chia-Yen Dai Digestive System Department
Wan-Long Chuang Digestive System Department
Ming-Lun Yeh Digestive System Department
梁博程 Digestive System Department
黃駿逸 Digestive System Department

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Pin-Nan Cheng

National Taiwan University Hospital

Co-Principal Investigator

簡世杰 Digestive System Department
邱彥程 Digestive System Department
Chiu Hung Chiu Digestive System Department

The Actual Total Number of Participants Enrolled

0 Terminated

Condition/Disease

Chronic Hepatitis B

Objectives

Primary objective: To evaluate the safety and tolerability of repeated administration of GS-2829 and GS-6779 in healthy participants and in participants with suppressed or viremic CHB. Secondary objective: To evaluate the immunogenicity of repeated administration of GS-2829 and GS-6779 in healthy participants and in participants with suppressed or viremic CHB.

Test Drug

注射劑
注射劑

Active Ingredient

GS-2829
GS-6779

Dosage Form

270
270

Dosage

≥ 1.0 x 107 focus-forming units (FFU)/mL

Endpoints

The proportion of participants who experienced adverse events (AEs), serious adverse events (SAEs), and abnormal laboratory test results during treatment.

Inclution Criteria

Key Inclusion Criteria:

Phase 1a and 1b:

Body mass index (BMI) of ≤ 32.0 kg/m^2.
Non-diabetic without impaired glucose tolerance.
No evidence of cardiac disease based on 12 lead ECG.
Phase 1a (Healthy Individuals) only:

Aged 18 through 60 years.
No history of Hepatitis B infection with a negative Hepatitis B virus (HBV) core Antibody.
Phase 1b (Virally suppressed CHB individuals):

Aged 18 through 65 years.
Documented CHB and HBsAg ≤ 5000 IU/mL at screening.
No evidence of advanced fibrosis by Fibroscan (defined as Fibroscan < 9 kPa within 6 months of screening).
Diagnosed with chronic hepatitis B on suppressive oral antiviral for ≥ 6 months.

Exclusion Criteria

Key Exclusion Criteria:

Phase 1a and 1b:

Use of any systemic antibiotics within 30 days of screening.
Receipt of any HBV vaccine within 12 months of screening visit or planning HBV vaccination during the study period.
Receipt of any investigational product within 3 months or vaccine within 3 months of screening (with the exception of influenza and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines, which if needed, should be administered at least 14 days before or after an investigational product administration).
Receipt of immunoglobulin or other blood products within 3 months of screening.
Positive serum pregnancy test at screening or positive urine pregnancy on Day 1.
Have been treated with systemic steroids, immunosuppressant therapies, or chemotherapeutic agents within 3 months prior to screening or is expected to receive these agents during the study (eg, corticosteroids, immunoglobulins, other immune or cytokine-based therapies).
Participation in any other clinical study (including observational studies) without prior approval from the sponsor is prohibited while participating in the study.

The Estimated Number of Participants

Taiwan

25 participants
Global

80 participants