Chronic Hepatitis BPhase 2NCT03615066
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
A Phase 2 study testing Selgantolimod and TAF in people with Chronic Hepatitis B, run by Gilead Sciences at 10 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- Selgantolimod and TAF
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 67 participants
- Where
- 10 sitesin 3 countries
- Study dates
- 28 Aug 2018to 12 Apr 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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.
Trial locations and contacts
10 sites in 3 countries.
10 sites in 3 countries
South Korea4 sites
Seoul National University Hospital
Seoul, 03080
Asan Medical Center
Seoul, 05505
Chung-Ang University Hospital
Seoul, 06973
Severance Hospital, Yonsei University Health System
Seoul, 120-752
Canada3 sites
University of Calgary Liver Unit - Heritage Medical Research Clinic
Calgary, Alberta, T2N4Z6
University Health Network, Toronto General Hospital, Toronto Centre for Liver Disease
Toronto, Ontario, M5G 2C4
Toronto Liver Centre
Toronto, Ontario, M6H 3M1
Taiwan3 sites
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807
E-Da Hospital
Kaohsiung City, 82445
National Taiwan University Hospital
Taipei, 10002
About this study
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
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.
- Conditions
- Chronic Hepatitis B
- Being tested
- Placebo, Selgantolimod, TAF
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Tablet(s) administered orally every 7 days for 24 doses in fasted state
SelgantolimodDrug
Also called GS-9688
Tablet(s) administered orally every 7 days for 24 doses in fasted state
TAFDrug
Also called Vemlidy®
Tablet(s) administered orally once daily with food
| Study group | Role | What they receive |
|---|---|---|
| Selgantolimod 3 mg + TAF | Experimental | 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. Receives: Drug: Selgantolimod; Drug: TAF |
| Selgantolimod 1.5 mg + TAF | Experimental | 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. Receives: Drug: Placebo; Drug: Selgantolimod; Drug: TAF |
| Placebo + TAF | Placebo comparator | 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. Receives: Drug: Placebo; Drug: TAF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum Quantitative Hepatitis B Surface Antigen (qHBsAg) From Baseline at Week 24
Measured: Baseline, 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.
Measured: First dose date up to Week 24 plus 30 days
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.
Measured: First dose date up to Week 24 plus 30 days
Secondary outcomes (28)
Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 4
Measured: Baseline, Week 4
Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 8
Measured: Baseline, Week 8
Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 12
Measured: Baseline, Week 12
Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 48
Measured: Baseline, Week 48
Change From Baseline in Serum qHBsAg at Week 4
Measured: Baseline, Week 4
Change From Baseline in Serum qHBsAg at Week 8
Measured: Baseline, Week 8
Change From Baseline in Serum qHBsAg at Week 12
Measured: Baseline, Week 12
Change From Baseline in Serum qHBsAg at Week 24
Measured: Baseline, Week 24
Change From Baseline in Serum qHBsAg at Week 48
Measured: Baseline, 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.
Measured: Week 12
Percentage of Participants With HBV DNA < LLOQ at Week 24
LLOQ was defined as 20 IU/mL.
Measured: Week 24
Percentage of Participants With HBV DNA < LLOQ at Week 48
LLOQ was defined as 20 IU/mL.
Measured: Week 48
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.
Measured: Week 12
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.
Measured: Week 24
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.
Measured: Week 48
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.
Measured: Week 12
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.
Measured: Week 24
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.
Measured: Week 48
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.
Measured: Baseline up to Week 24
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.
Measured: Baseline up to Week 48
Percentage of Participants With Drug Resistance Mutations
Measured: Baseline up to Week 48
Pharmacokinetic (PK) Parameter: AUClast of Selgantolimod
AUClast is defined as the concentration of drug from time zero to the last observable concentration.
Measured: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose at Day 1 and Week 23
PK Parameter: AUC0-24 of Selgantolimod
AUC0-24 is defined as the concentration of drug over time from time zero to time 24 hours.
Measured: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose at Day 1 and Week 23
PK Parameter: AUCinf of Selgantolimod
AUC0-inf is defined as the concentration of drug over time from time zero to infinity.
Measured: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose at Day 1 and Week 23
PK Parameter: Cmax of Selgantolimod
Cmax is defined as the maximum concentration of drug.
Measured: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose at Day 1 and Week 23
PK Parameter: Tmax of Selgantolimod
Tmax is defined as the time (observed time point) of Cmax.
Measured: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose at Day 1 and Week 23
PK Parameter: CL/F of Selgantolimod
CL/F is defined as the apparent oral clearance following administration of the drug.
Measured: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose at Day 1 and Week 23
PK Parameter: t1/2 of Selgantolimod
t1/2 is defined as the estimate of the terminal elimination half-life of the drug.
Measured: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose at Day 1 and Week 23
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2018
- Study start28 Aug 2018
- Primary completion12 Dec 2019
- Study completion12 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Hepatitis BStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilead Study Director, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03615066
- Sponsor's protocol ID
- GS-US-389-2025
- Status last verified
- Apr 2022
- First submitted
- 30 Jul 2018
- Last updated
- 10 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
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.
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.
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03615066
- Acronym / sponsor ID
- GS-US-389-2025
- Conditions
- Chronic Hepatitis B
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- 28 Aug 2018 (actual)
- Primary completion
- 12 Dec 2019 (actual)
- Study completion
- 12 Apr 2021 (actual)
- First posted
- 3 Aug 2018 (actual)
- Results
- Posted 6 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Selgantolimod 3 mg + TAF | Experimental | Drug: Selgantolimod, Drug: TAFParticipants 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. |
| Selgantolimod 1.5 mg + TAF | Experimental | Drug: Placebo, Drug: Selgantolimod, Drug: TAFParticipants 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. |
| Placebo + TAF | Placebo comparator | Drug: Placebo, Drug: TAFParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 (17 listed)
- 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:
- Co-infection with human immunodeficiency virus (HIV), hepatitis C virus or hepatitis D virus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboTablet(s) administered orally every 7 days for 24 doses in fasted state | Drug | Placebo + TAF, Selgantolimod 1.5 mg + TAF |
| SelgantolimodAlso: GS-9688Tablet(s) administered orally every 7 days for 24 doses in fasted state | Drug | Selgantolimod 1.5 mg + TAF, Selgantolimod 3 mg + TAF |
| TAFAlso: Vemlidy®Tablet(s) administered orally once daily with food | Drug | Placebo + TAF, Selgantolimod 1.5 mg + TAF, Selgantolimod 3 mg + TAF |
Primary outcome
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
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: First dose date up to Week 24 plus 30 days
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
Time frame: First dose date up to Week 24 plus 30 days
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.
28 secondary outcomes
Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 4
Time frame: Baseline, Week 4
Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 8
Time frame: Baseline, Week 8
Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 12
Time frame: Baseline, Week 12
Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 48
Time frame: Baseline, Week 48
Change From Baseline in Serum qHBsAg at Week 4
Time frame: Baseline, Week 4
Change From Baseline in Serum qHBsAg at Week 8
Time frame: Baseline, Week 8
Change From Baseline in Serum qHBsAg at Week 12
Time frame: Baseline, Week 12
Change From Baseline in Serum qHBsAg at Week 24
Time frame: Baseline, Week 24
Change From Baseline in Serum qHBsAg at Week 48
Time frame: Baseline, Week 48
Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) < Lower Limit of Quantification (LLOQ) at Week 12
Time frame: Week 12
Percentage of Participants With HBV DNA < LLOQ at Week 24
Time frame: Week 24
Percentage of Participants With HBV DNA < LLOQ at Week 48
Time frame: Week 48
Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 12
Time frame: Week 12
Percentage of Participants With HBsAg Loss at Week 24
Time frame: Week 24
Percentage of Participants With HBsAg Loss at Week 48
Time frame: Week 48
Percentage of Participants With HBeAg Loss and Seroconversion at Week 12
Time frame: Week 12
Percentage of Participants With HBeAg Loss and Seroconversion at Week 24
Time frame: Week 24
Percentage of Participants With HBeAg Loss and Seroconversion at Week 48
Time frame: Week 48
Percentage of Participants With Virologic Breakthrough From Baseline up to Week 24
Time frame: Baseline up to Week 24
Percentage of Participants With Virologic Breakthrough From Baseline up to Week 48
Time frame: Baseline up to Week 48
Percentage of Participants With Drug Resistance Mutations
Time frame: Baseline up to Week 48
Pharmacokinetic (PK) Parameter: AUClast of Selgantolimod
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
PK Parameter: AUC0-24 of Selgantolimod
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
PK Parameter: AUCinf of Selgantolimod
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
PK Parameter: Cmax of Selgantolimod
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
PK Parameter: Tmax of Selgantolimod
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
PK Parameter: CL/F of Selgantolimod
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
PK Parameter: t1/2 of Selgantolimod
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundChen 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.
- BackgroundJanssen 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.
- BackgroundJanssen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilead Study Director study director
Gilead Sciences
10 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Selgantolimod and TAF in people with Chronic Hepatitis B, run by Gilead Sciences at 10 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in South Korea, Canada, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03615066, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2022.