Clinical Trials List
Protocol NumberGS-US-389-5458
2019-07-05 - 2022-03-21
Phase I
Recruiting5
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 1b, Open-label, Multi-center Study to Evaluate the Safety, Tolerability and Activity of GS-9688 in Special Populations of Subjects with Chronic Hepatitis B
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Trial Applicant
GILEAD SCIENCES HONG KONG LIMITED
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Sponsor
Gilead Sciences Hong Kong Limited Taiwan Branch
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chiu Hung Chiu Division of General Internal Medicine
- 簡世杰 Division of General Internal Medicine
- 黃福進 Division of General Internal Medicine
- 邱彥程 Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Jia-Horng Kao Division of General Internal Medicine
- Ta-Ching Chen Division of General Internal Medicine
- 楊宏志 Division of General Internal Medicine
- 吳慧琳 Division of General Internal Medicine
- Shih-Jer Hsu Division of General Internal Medicine
- 洪俊銘 Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Jee-Fu Huang Digestive System Department
- Chia-Yen Dai Digestive System Department
- Chung-Feng Huang Digestive System Department
- 徐旭亮 Digestive System Department
- Ming-Lung Yu Digestive System Department
- 黃駿逸 Digestive System Department
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Chronic Hepatitis B
Objectives
The primary objectives of this study are:
To evaluate the safety and tolerability of multiple oral doses of GS-9688 at Week 24 in special populations of CHB adult subjects
To evaluate the antiviral activity of GS-9688 as measured by the proportion of subjects with ≥ 1 log10 IU/mL decline from baseline (Day 1) in serum quantitative HBsAg (qHBsAg) at Week 24
To evaluate the antiviral activity of GS-9688 as measured by the proportion of subjects with HBV DNA < lower limit of quantitation (LLOQ) at Week 24 for Cohorts 1 and 2
To evaluate the antiviral activity of GS-9688 as measured by the proportion of subjects with ≥ 2 log10 copies/mL decline from baseline (Day 1) in HDV RNA at Week 24 for Cohort 3
Test Drug
GS-9688 Filmed-coated Tablets
Active Ingredient
GS-9688
Dosage Form
Tablet
Dosage
1.5
Endpoints
The primary endpoints of this study are:
Proportion of subjects with ≥ 1 log10 IU/mL decline in serum qHBsAg from baseline (Day 1) at Week 24
Proportion of subjects with HBV DNA < LLOQ at Week 24 for Cohorts 1 and 2
Proportion of subjects with ≥ 2 log10 copies/mL decline from baseline (Day 1) in HDV RNA at Week 24 for Cohort 3
The secondary endpoints of this study are:
Proportion of subjects with ≥ 1 log10 IU/mL decline in serum qHBsAg from baseline (Day 1) at Weeks 4, 8, 12, 36, and 48
Change in serum qHBsAg (log10 IU/mL) from baseline (Day 1) at Weeks 4, 8, 12, 24, 36, and 48
Proportion of subjects with HBV DNA < LLOQ at Weeks 12, 36, and 48 for Cohorts 1 and 2
Proportion of subjects with ≥ 2 log10 copies/mL decline from baseline (Day 1) in HDV RNA at Weeks 4, 8, 12, 36, and 48 for Cohort 3
Change in HDV RNA (log10 copies/mL) from baseline (Day 1) to Weeks 4, 8, 12, 24, 36, and 48 for Cohort 3
Proportion of subjects with HBsAg loss through Week 48
Proportion of subjects with HBeAg loss and/or seroconversion through Week 48 at Weeks 12, 24, 36, and 48 for Cohorts 1 and 3
Proportion of subjects with HBV virologic breakthrough (2 consecutive visits of HBV DNA ≥ 69 IU/mL) for Cohort 3
Proportion of subjects with ≥ 1 log10 IU/mL decline in serum qHBsAg from baseline (Day 1) at Week 24
Proportion of subjects with HBV DNA < LLOQ at Week 24 for Cohorts 1 and 2
Proportion of subjects with ≥ 2 log10 copies/mL decline from baseline (Day 1) in HDV RNA at Week 24 for Cohort 3
The secondary endpoints of this study are:
Proportion of subjects with ≥ 1 log10 IU/mL decline in serum qHBsAg from baseline (Day 1) at Weeks 4, 8, 12, 36, and 48
Change in serum qHBsAg (log10 IU/mL) from baseline (Day 1) at Weeks 4, 8, 12, 24, 36, and 48
Proportion of subjects with HBV DNA < LLOQ at Weeks 12, 36, and 48 for Cohorts 1 and 2
Proportion of subjects with ≥ 2 log10 copies/mL decline from baseline (Day 1) in HDV RNA at Weeks 4, 8, 12, 36, and 48 for Cohort 3
Change in HDV RNA (log10 copies/mL) from baseline (Day 1) to Weeks 4, 8, 12, 24, 36, and 48 for Cohort 3
Proportion of subjects with HBsAg loss through Week 48
Proportion of subjects with HBeAg loss and/or seroconversion through Week 48 at Weeks 12, 24, 36, and 48 for Cohorts 1 and 3
Proportion of subjects with HBV virologic breakthrough (2 consecutive visits of HBV DNA ≥ 69 IU/mL) for Cohort 3
Inclution Criteria
1) Must have the ability to understand and sign a written ICF, which must be obtained prior to initiation of study procedures
2) Adult male and nonpregnant, nonlactating female subjects, 18 to 65 years of age, inclusive, based on the date of the screening visit
3) Documented evidence of chronic HBV infection (eg, HBsAg positive for more than 6 months) with detectable HBsAg levels at screening (no retest permitted if initial screening HBsAg is negative)
For Cohort 2, screening qHBsAg must be ≤ 1000 IU/mL
4) Male and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception as described in Appendix 3.
5) Screening HBV DNA:
a) Cohort 1: ≥ 1 × 107 IU/mL
b) Cohort 2: ≤ 2000 IU/mL (also measured at least once by local laboratory assessment) for 3 or more months prior to screening
c) Cohort 3: < LLOQ (by central laboratory testing) with at least 1 prior documented result of HBV DNA ≤ 20 IU/mL from a local laboratory for 6 or more months prior to screening
6) Screening ECG without clinically significant abnormalities and with QTcF ≤ 450 msec for males and ≤ 470 msec for females
7) Must be willing and able to comply with all study requirements
Inclusion criteria for Cohort 3 only
8) Positive anti-HDV antibodies for at least 3 months prior to screening
9) Detectable screening HDV RNA by central laboratory testing
2) Adult male and nonpregnant, nonlactating female subjects, 18 to 65 years of age, inclusive, based on the date of the screening visit
3) Documented evidence of chronic HBV infection (eg, HBsAg positive for more than 6 months) with detectable HBsAg levels at screening (no retest permitted if initial screening HBsAg is negative)
For Cohort 2, screening qHBsAg must be ≤ 1000 IU/mL
4) Male and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception as described in Appendix 3.
5) Screening HBV DNA:
a) Cohort 1: ≥ 1 × 107 IU/mL
b) Cohort 2: ≤ 2000 IU/mL (also measured at least once by local laboratory assessment) for 3 or more months prior to screening
c) Cohort 3: < LLOQ (by central laboratory testing) with at least 1 prior documented result of HBV DNA ≤ 20 IU/mL from a local laboratory for 6 or more months prior to screening
6) Screening ECG without clinically significant abnormalities and with QTcF ≤ 450 msec for males and ≤ 470 msec for females
7) Must be willing and able to comply with all study requirements
Inclusion criteria for Cohort 3 only
8) Positive anti-HDV antibodies for at least 3 months prior to screening
9) Detectable screening HDV RNA by central laboratory testing
Exclusion Criteria
10) Evidence of bridging fibrosis or cirrhosis confirmed by screening biopsy (biopsy will only be
performed if a subject meets all inclusion/exclusion by history and laboratory screening
assessments)
11) Received prolonged systemic therapy with immunomodulators (eg, corticosteroids) or
biologics (eg, monoclonal antibody, IFN) within 3 months of screening
12) Subjects meeting any of the following laboratory parameters at screening
13) Estimated creatinine clearance (CLcr) < 60 mL/min (using the Cockcroft-Gault method)
based on serum creatinine and actual body weight as measured at the screening evaluation
14) Coinfection with HIV or hepatitis C virus (HCV)
a) Subjects who are HCV Ab positive but have a documented negative HCV RNA are
eligible
15) Prior history of HCC (eg, as evidenced by prior imaging) or screening alpha-fetoprotein
(AFP) ≥ 50 ng/mL without imaging to rule out HCC
Exclusion criteria for Cohort 1 only
30) HBeAg negativity or borderline result at screening
Exclusion criteria for Cohort 2 only
31) HBeAg positivity at screening
Exclusion criteria for Cohorts 1 and 2 only
32) Coinfection with HDV
Subjects who are HDV Ab positive but have a documented negative HDV RNA are
eligible
33) Received a commercially available HBV OAV treatment(s) (tenofovir alafenamide, tenofovir
disoproxil fumarate, entecavir, adefovir, lamivudine, or telbivudine, either as single agents or
in combination) within the 6 months prior to screening
Exclusion criteria for Cohort 3 only
34) Received IFN therapy within the 12 months prior to screening
performed if a subject meets all inclusion/exclusion by history and laboratory screening
assessments)
11) Received prolonged systemic therapy with immunomodulators (eg, corticosteroids) or
biologics (eg, monoclonal antibody, IFN) within 3 months of screening
12) Subjects meeting any of the following laboratory parameters at screening
13) Estimated creatinine clearance (CLcr) < 60 mL/min (using the Cockcroft-Gault method)
based on serum creatinine and actual body weight as measured at the screening evaluation
14) Coinfection with HIV or hepatitis C virus (HCV)
a) Subjects who are HCV Ab positive but have a documented negative HCV RNA are
eligible
15) Prior history of HCC (eg, as evidenced by prior imaging) or screening alpha-fetoprotein
(AFP) ≥ 50 ng/mL without imaging to rule out HCC
Exclusion criteria for Cohort 1 only
30) HBeAg negativity or borderline result at screening
Exclusion criteria for Cohort 2 only
31) HBeAg positivity at screening
Exclusion criteria for Cohorts 1 and 2 only
32) Coinfection with HDV
Subjects who are HDV Ab positive but have a documented negative HDV RNA are
eligible
33) Received a commercially available HBV OAV treatment(s) (tenofovir alafenamide, tenofovir
disoproxil fumarate, entecavir, adefovir, lamivudine, or telbivudine, either as single agents or
in combination) within the 6 months prior to screening
Exclusion criteria for Cohort 3 only
34) Received IFN therapy within the 12 months prior to screening
The Estimated Number of Participants
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Taiwan
35 participants
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Global
45 participants
