Clinical Trials List
2023-02-15 - 2025-06-30
Phase I
Recruiting10
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)
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Trial Applicant
GILEAD SCIENCES HONG KONG LIMITED
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Sponsor
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- Chia-Yen Dai 無
- 黃駿逸 無
- Wan-Long Chuang 無
- Ming-Lun Yeh 無
- Chung-Feng Huang 無
- Jee-Fu Huang 無
- 梁博程 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Jia-Horng Kao 無
- 廖思涵 無
- Shih-Jer Hsu 無
- Chun-Jen Liu 無
- PEI-JER CHEN 無
- 曾岱宗 無
- 洪俊銘 無
- 楊宏志 無
- Chen-Hua Liu 無
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 戴達英 無
- Yi-Cheng Chen 無
- 鄭雅婷 無
- Chun-Yen Lin 無
- Yi-Chung Hsieh 無
- 林伯庭 無
- I-Shyan Sheen 無
- Chao-Wei Hsu 無
- 劉彦君 無
- Rong-Nan Chien 無
- Chien-Hao Huang 無
- 滕威 無
- 陳正仁 無
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 呂宜達 無
- CHUNG-HSIN CHANG 無
- 李少武 無
- TENG-YU LEE 無
- 蔡炘儒 無
- 林宛姿 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
GS-6779
Dosage Form
Solution for Injection
Dosage
? 1.0 x 107 focus-forming units (FFU)/mL
Endpoints
Inclution 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
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
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Taiwan
25 participants
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Global
80 participants
