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Study to Evaluate the Safety, Tolerability, and Antiviral Activity of Selgantolimod (Formerly GS-9688) in Viremic Adult Participants With Chronic Hepatitis B (CHB) Who Are Not Currently on Treatment

Primary Purpose

Chronic Hepatitis B

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Placebo
Selgantolimod
TAF
Sponsored by
Gilead Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis B

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

  • Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures.
  • Adult male and non-pregnant, non-lactating females
  • Documented evidence of chronic hepatitis B virus (HBV) infection with detectable hepatitis B surface antigen (HBsAg) levels at screening
  • Screening HBV deoxyribonucleic acid (DNA) ≥ 2000 international units per milliliter (IU/mL).
  • Screening electrocardiogram (ECG) without clinically significant abnormalities

Key Exclusion Criteria:

  • Extensive bridging fibrosis or cirrhosis
  • Received a commercially available HBV OAV treatment(s) within the 3 months prior to screening.
  • Received prolonged therapy with immunomodulators or biologics within 3 months of screening

  • Individuals meeting any of the following laboratory parameters at screening:

    • Alanine aminotransferase > 5 * upper limit of normal (ULN)
    • International normalized ratio > ULN unless the individual is stable on an anticoagulant regimen
    • Albumin < 3.5 g/dL
    • Direct bilirubin >1.5x ULN
    • Platelet Count < 100,000/µL
    • Estimated creatinine clearance < 60 mL/min (using the Cockcroft-Gault method)
  • Co-infection with human immunodeficiency virus (HIV), hepatitis C virus or hepatitis D virus
  • Prior history of hepatocellular carcinoma or screening alpha-fetoprotein ≥ 50 ng/mL without imaging
  • Diagnosis of autoimmune disease, poorly controlled diabetes mellitus, significant psychiatric illness, severe chronic obstructive pulmonary disease, hemoglobinopathy, retinal disease, or are immunosuppressed.
  • Chronic liver disease of a non-HBV etiology except for non-alcoholic fatty liver disease.
  • Received solid organ or bone marrow transplant.
  • Use of another investigational agent within 90 days of screening, unless allowed by the sponsor.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Sites / Locations

  • University of Calgary Liver Unit - Heritage Medical Research Clinic
  • University Health Network, Toronto General Hospital, Toronto Centre for Liver Disease
  • Toronto Liver Centre
  • Seoul National University Hospital
  • Asan Medical Center
  • Chung-Ang University Hospital
  • Severance Hospital, Yonsei University Health System
  • E-Da Hospital
  • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • National Taiwan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Selgantolimod 3 mg + TAF

Selgantolimod 1.5 mg + TAF

Placebo + TAF

Arm Description

Participants with Hepatitis B e antigen (HBeAg)-positive CHB or HBeAg-negative CHB currently not on oral antiviral (OAV) treatment, will receive selgantolimod 3 mg (2 x 1.5 mg tablet) on the same day once weekly for 24 doses along with tenofovir alafenamide (TAF) 25 mg once daily for 24 weeks. After the 24th dose, selgantolimod will be discontinued, and participants will continue to receive TAF until Week 48/early discontinuation (ED). At Week 48, per Principal Investigator's (PI's) discretion, participants can continue in the Treatment Free Follow-Up (TFFU) phase for up to an additional 48 weeks.

Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, will receive selgantolimod 1.5 mg (1 x 1.5 mg tablet) and placebo (1 tablet) on the same day once weekly for 24 doses along with TAF 25 mg once daily for 24 weeks. After the 24th dose, selgantolimod will be discontinued, and participants will continue to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.

Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, will receive 2 tablets of placebo on the same day once weekly for 24 doses along with TAF 25 mg once daily for 24 weeks. After the 24th dose, placebo will be discontinued, and participants will continue to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.

Outcomes

Primary Outcome Measures

Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum Quantitative Hepatitis B Surface Antigen (qHBsAg) From Baseline at Week 24
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
An AE was any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE was any unfavorable and unintended sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the investigational medicinal product. A TEAE was defined as any AE with an onset date on or after the first dose date and no later than 30 days after permanent discontinuation of selgantolimod/placebo; or any AE leading to premature discontinuation of study drugs.
Percentage of Participants With Treatment-Emergent Laboratory Abnormalities
Treatment-emergent laboratory abnormalities were defined as values that increased at least 1 toxicity grade from baseline at any postbaseline time point, up to and including the date of the last dose of study drug plus 30 days for selgantolimod/placebo at Week 24. If the relevant baseline laboratory value was missing, any abnormality of at least Grade 1 observed within the time frame specified above was considered treatment emergent. Clinical laboratory results were graded according to Gilead Grading Scale for Severity of Adverse Events and Laboratory Abnormalities.

Secondary Outcome Measures

Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 4
Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 8
Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 12
Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 48
Change From Baseline in Serum qHBsAg at Week 4
Change From Baseline in Serum qHBsAg at Week 8
Change From Baseline in Serum qHBsAg at Week 12
Change From Baseline in Serum qHBsAg at Week 24
Change From Baseline in Serum qHBsAg at Week 48
Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) < Lower Limit of Quantification (LLOQ) at Week 12
LLOQ was defined as 20 IU/mL.
Percentage of Participants With HBV DNA < LLOQ at Week 24
LLOQ was defined as 20 IU/mL.
Percentage of Participants With HBV DNA < LLOQ at Week 48
LLOQ was defined as 20 IU/mL.
Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 12
HBsAg loss was defined as qualitative HBsAg changing from positive at baseline to negative at a postbaseline visit.
Percentage of Participants With HBsAg Loss at Week 24
HBsAg loss was defined as qualitative HBsAg changing from positive at baseline to negative at a postbaseline visit.
Percentage of Participants With HBsAg Loss at Week 48
HBsAg loss was defined as qualitative HBsAg changing from positive at baseline to negative at a postbaseline visit.
Percentage of Participants With HBeAg Loss and Seroconversion at Week 12
HBeAg loss was defined as qualitative HBeAg changing from positive at baseline to negative at a postbaseline visit. HBeAg seroconversion was defined as Hepatitis B e antibody (HBeAb) loss and anti-HBe change from negative/missing at baseline to positive at a postbaseline visit.
Percentage of Participants With HBeAg Loss and Seroconversion at Week 24
HBeAg loss was defined as qualitative HBeAg changing from positive at baseline to negative at a postbaseline visit. HBeAg seroconversion was defined as HBeAb loss and anti-HBe change from negative/missing at baseline to positive at a postbaseline visit.
Percentage of Participants With HBeAg Loss and Seroconversion at Week 48
HBeAg loss was defined as qualitative HBeAg changing from positive at baseline to negative at a postbaseline visit. HBeAg seroconversion was defined as HBeAb test changing from negative or missing at baseline to positive at a postbaseline visit.
Percentage of Participants With Virologic Breakthrough From Baseline up to Week 24
Virologic breakthrough was defined as confirmed HBV DNA ≥ 69 IU/mL after having been < 69 IU/mL or confirmed HBV DNA ≥ 1 log10 IU/mL increase from nadir.
Percentage of Participants With Virologic Breakthrough From Baseline up to Week 48
Virologic breakthrough was defined as confirmed HBV DNA ≥ 69 IU/mL after having been < 69 IU/mL or confirmed HBV DNA ≥ 1 log10 IU/mL increase from nadir.
Percentage of Participants With Drug Resistance Mutations
Pharmacokinetic (PK) Parameter: AUClast of Selgantolimod
AUClast is defined as the concentration of drug from time zero to the last observable concentration.
PK Parameter: AUC0-24 of Selgantolimod
AUC0-24 is defined as the concentration of drug over time from time zero to time 24 hours.
PK Parameter: AUCinf of Selgantolimod
AUC0-inf is defined as the concentration of drug over time from time zero to infinity.
PK Parameter: Cmax of Selgantolimod
Cmax is defined as the maximum concentration of drug.
PK Parameter: Tmax of Selgantolimod
Tmax is defined as the time (observed time point) of Cmax.
PK Parameter: CL/F of Selgantolimod
CL/F is defined as the apparent oral clearance following administration of the drug.
PK Parameter: t1/2 of Selgantolimod
t1/2 is defined as the estimate of the terminal elimination half-life of the drug.

Full Information

First Posted
July 30, 2018
Last Updated
April 11, 2022
Sponsor
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03615066
Brief Title
Study to Evaluate the Safety, Tolerability, and Antiviral Activity of Selgantolimod (Formerly GS-9688) in Viremic Adult Participants With Chronic Hepatitis B (CHB) Who Are Not Currently on Treatment
Official Title
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-center Study to Evaluate the Safety, Tolerability and Antiviral Activity of GS-9688 in Viremic Adult Subjects With Chronic Hepatitis B Who Are Not Currently on Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
August 28, 2018 (Actual)
Primary Completion Date
December 12, 2019 (Actual)
Study Completion Date
April 12, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary objectives of this study are to evaluate the safety and tolerability of multiple oral doses of selgantolimod and to evaluate the antiviral activity of selgantolimod in adult participants with chronic hepatitis B (CHB) who are viremic and not currently being treated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis B

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
67 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Selgantolimod 3 mg + TAF
Arm Type
Experimental
Arm Description
Participants with Hepatitis B e antigen (HBeAg)-positive CHB or HBeAg-negative CHB currently not on oral antiviral (OAV) treatment, will receive selgantolimod 3 mg (2 x 1.5 mg tablet) on the same day once weekly for 24 doses along with tenofovir alafenamide (TAF) 25 mg once daily for 24 weeks. After the 24th dose, selgantolimod will be discontinued, and participants will continue to receive TAF until Week 48/early discontinuation (ED). At Week 48, per Principal Investigator's (PI's) discretion, participants can continue in the Treatment Free Follow-Up (TFFU) phase for up to an additional 48 weeks.
Arm Title
Selgantolimod 1.5 mg + TAF
Arm Type
Experimental
Arm Description
Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, will receive selgantolimod 1.5 mg (1 x 1.5 mg tablet) and placebo (1 tablet) on the same day once weekly for 24 doses along with TAF 25 mg once daily for 24 weeks. After the 24th dose, selgantolimod will be discontinued, and participants will continue to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.
Arm Title
Placebo + TAF
Arm Type
Placebo Comparator
Arm Description
Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, will receive 2 tablets of placebo on the same day once weekly for 24 doses along with TAF 25 mg once daily for 24 weeks. After the 24th dose, placebo will be discontinued, and participants will continue to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Tablet(s) administered orally every 7 days for 24 doses in fasted state
Intervention Type
Drug
Intervention Name(s)
Selgantolimod
Other Intervention Name(s)
GS-9688
Intervention Description
Tablet(s) administered orally every 7 days for 24 doses in fasted state
Intervention Type
Drug
Intervention Name(s)
TAF
Other Intervention Name(s)
Vemlidy®
Intervention Description
Tablet(s) administered orally once daily with food
Primary Outcome Measure Information:
Title
Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum Quantitative Hepatitis B Surface Antigen (qHBsAg) From Baseline at Week 24
Time Frame
Baseline, Week 24
Title
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
Description
An AE was any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE was any unfavorable and unintended sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the investigational medicinal product. A TEAE was defined as any AE with an onset date on or after the first dose date and no later than 30 days after permanent discontinuation of selgantolimod/placebo; or any AE leading to premature discontinuation of study drugs.
Time Frame
First dose date up to Week 24 plus 30 days
Title
Percentage of Participants With Treatment-Emergent Laboratory Abnormalities
Description
Treatment-emergent laboratory abnormalities were defined as values that increased at least 1 toxicity grade from baseline at any postbaseline time point, up to and including the date of the last dose of study drug plus 30 days for selgantolimod/placebo at Week 24. If the relevant baseline laboratory value was missing, any abnormality of at least Grade 1 observed within the time frame specified above was considered treatment emergent. Clinical laboratory results were graded according to Gilead Grading Scale for Severity of Adverse Events and Laboratory Abnormalities.
Time Frame
First dose date up to Week 24 plus 30 days
Secondary Outcome Measure Information:
Title
Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 4
Time Frame
Baseline, Week 4
Title
Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 8
Time Frame
Baseline, Week 8
Title
Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 12
Time Frame
Baseline, Week 12
Title
Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 48
Time Frame
Baseline, Week 48
Title
Change From Baseline in Serum qHBsAg at Week 4
Time Frame
Baseline, Week 4
Title
Change From Baseline in Serum qHBsAg at Week 8
Time Frame
Baseline, Week 8
Title
Change From Baseline in Serum qHBsAg at Week 12
Time Frame
Baseline, Week 12
Title
Change From Baseline in Serum qHBsAg at Week 24
Time Frame
Baseline, Week 24
Title
Change From Baseline in Serum qHBsAg at Week 48
Time Frame
Baseline, Week 48
Title
Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) < Lower Limit of Quantification (LLOQ) at Week 12
Description
LLOQ was defined as 20 IU/mL.
Time Frame
Week 12
Title
Percentage of Participants With HBV DNA < LLOQ at Week 24
Description
LLOQ was defined as 20 IU/mL.
Time Frame
Week 24
Title
Percentage of Participants With HBV DNA < LLOQ at Week 48
Description
LLOQ was defined as 20 IU/mL.
Time Frame
Week 48
Title
Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 12
Description
HBsAg loss was defined as qualitative HBsAg changing from positive at baseline to negative at a postbaseline visit.
Time Frame
Week 12
Title
Percentage of Participants With HBsAg Loss at Week 24
Description
HBsAg loss was defined as qualitative HBsAg changing from positive at baseline to negative at a postbaseline visit.
Time Frame
Week 24
Title
Percentage of Participants With HBsAg Loss at Week 48
Description
HBsAg loss was defined as qualitative HBsAg changing from positive at baseline to negative at a postbaseline visit.
Time Frame
Week 48
Title
Percentage of Participants With HBeAg Loss and Seroconversion at Week 12
Description
HBeAg loss was defined as qualitative HBeAg changing from positive at baseline to negative at a postbaseline visit. HBeAg seroconversion was defined as Hepatitis B e antibody (HBeAb) loss and anti-HBe change from negative/missing at baseline to positive at a postbaseline visit.
Time Frame
Week 12
Title
Percentage of Participants With HBeAg Loss and Seroconversion at Week 24
Description
HBeAg loss was defined as qualitative HBeAg changing from positive at baseline to negative at a postbaseline visit. HBeAg seroconversion was defined as HBeAb loss and anti-HBe change from negative/missing at baseline to positive at a postbaseline visit.
Time Frame
Week 24
Title
Percentage of Participants With HBeAg Loss and Seroconversion at Week 48
Description
HBeAg loss was defined as qualitative HBeAg changing from positive at baseline to negative at a postbaseline visit. HBeAg seroconversion was defined as HBeAb test changing from negative or missing at baseline to positive at a postbaseline visit.
Time Frame
Week 48
Title
Percentage of Participants With Virologic Breakthrough From Baseline up to Week 24
Description
Virologic breakthrough was defined as confirmed HBV DNA ≥ 69 IU/mL after having been < 69 IU/mL or confirmed HBV DNA ≥ 1 log10 IU/mL increase from nadir.
Time Frame
Baseline up to Week 24
Title
Percentage of Participants With Virologic Breakthrough From Baseline up to Week 48
Description
Virologic breakthrough was defined as confirmed HBV DNA ≥ 69 IU/mL after having been < 69 IU/mL or confirmed HBV DNA ≥ 1 log10 IU/mL increase from nadir.
Time Frame
Baseline up to Week 48
Title
Percentage of Participants With Drug Resistance Mutations
Time Frame
Baseline up to Week 48
Title
Pharmacokinetic (PK) Parameter: AUClast of Selgantolimod
Description
AUClast is defined as the concentration of drug from time zero to the last observable concentration.
Time Frame
Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose at Day 1 and Week 23
Title
PK Parameter: AUC0-24 of Selgantolimod
Description
AUC0-24 is defined as the concentration of drug over time from time zero to time 24 hours.
Time Frame
Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose at Day 1 and Week 23
Title
PK Parameter: AUCinf of Selgantolimod
Description
AUC0-inf is defined as the concentration of drug over time from time zero to infinity.
Time Frame
Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose at Day 1 and Week 23
Title
PK Parameter: Cmax of Selgantolimod
Description
Cmax is defined as the maximum concentration of drug.
Time Frame
Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose at Day 1 and Week 23
Title
PK Parameter: Tmax of Selgantolimod
Description
Tmax is defined as the time (observed time point) of Cmax.
Time Frame
Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose at Day 1 and Week 23
Title
PK Parameter: CL/F of Selgantolimod
Description
CL/F is defined as the apparent oral clearance following administration of the drug.
Time Frame
Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose at Day 1 and Week 23
Title
PK Parameter: t1/2 of Selgantolimod
Description
t1/2 is defined as the estimate of the terminal elimination half-life of the drug.
Time Frame
Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose at Day 1 and Week 23

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures. Adult male and non-pregnant, non-lactating females Documented evidence of chronic hepatitis B virus (HBV) infection with detectable hepatitis B surface antigen (HBsAg) levels at screening Screening HBV deoxyribonucleic acid (DNA) ≥ 2000 international units per milliliter (IU/mL). Screening electrocardiogram (ECG) without clinically significant abnormalities Key Exclusion Criteria: Extensive bridging fibrosis or cirrhosis Received a commercially available HBV OAV treatment(s) within the 3 months prior to screening. Received prolonged therapy with immunomodulators or biologics within 3 months of screening Individuals meeting any of the following laboratory parameters at screening: Alanine aminotransferase > 5 * upper limit of normal (ULN) International normalized ratio > ULN unless the individual is stable on an anticoagulant regimen Albumin < 3.5 g/dL Direct bilirubin >1.5x ULN Platelet Count < 100,000/µL Estimated creatinine clearance < 60 mL/min (using the Cockcroft-Gault method) Co-infection with human immunodeficiency virus (HIV), hepatitis C virus or hepatitis D virus Prior history of hepatocellular carcinoma or screening alpha-fetoprotein ≥ 50 ng/mL without imaging Diagnosis of autoimmune disease, poorly controlled diabetes mellitus, significant psychiatric illness, severe chronic obstructive pulmonary disease, hemoglobinopathy, retinal disease, or are immunosuppressed. Chronic liver disease of a non-HBV etiology except for non-alcoholic fatty liver disease. Received solid organ or bone marrow transplant. Use of another investigational agent within 90 days of screening, unless allowed by the sponsor. Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilead Study Director
Organizational Affiliation
Gilead Sciences
Official's Role
Study Director
Facility Information:
Facility Name
University of Calgary Liver Unit - Heritage Medical Research Clinic
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N4Z6
Country
Canada
Facility Name
University Health Network, Toronto General Hospital, Toronto Centre for Liver Disease
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
Facility Name
Toronto Liver Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6H 3M1
Country
Canada
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Chung-Ang University Hospital
City
Seoul
ZIP/Postal Code
06973
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
E-Da Hospital
City
Kaohsiung City
ZIP/Postal Code
82445
Country
Taiwan
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei City
ZIP/Postal Code
10002
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
Chen D, Kim S, Brooks A, McDonald C, Yang J, Gaggar A, et al. Potential Biomarkers of Response in Chronic Hepatitis B Patients Who Achieved HBeAg Loss Upon Treatment With Toll-Like Receptor 8 Agonist Selgantolimod [Poster]. The Digital International Liver Conference 2020 27-29 August.
Results Reference
background
Citation
Janssen H, Lampertico P, Chen C-Y, Heo J, Foumier C, Ahn S, et al. Safety and Efficacy of Switching to Tenofovir Alafenamide in Virally Suppressed Chronic Hepatitis B Patients With Renal Impairment: Week-48 Results From a Phase 2 Open-label Study [Poster]. The Digital International Liver Conference 2020 27-29 August.
Results Reference
background
Citation
Janssen H, Lim Y-S, Kim HJ, Tseng C-H, Coffin C, Elkashab M, et al. Safety and Efficacy of Oral TLR8 Agonist Selgantolimod in Viremic Adult Patients With Chronic Hepatitis B [Poster]. International Liver Congress 2021 23-26 June.
Results Reference
background

Learn more about this trial

Study to Evaluate the Safety, Tolerability, and Antiviral Activity of Selgantolimod (Formerly GS-9688) in Viremic Adult Participants With Chronic Hepatitis B (CHB) Who Are Not Currently on Treatment

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