Safety, Tolerability and Antiviral Activity of Selgantolimod in Virally-Suppressed Participants With Chronic Hepatitis B
NCT ID: NCT03491553
Last Updated: 2021-08-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
48 participants
INTERVENTIONAL
2018-04-06
2020-08-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Selgantolimod 3 mg: HBeAg-positive CHB Participants
Participants with Hepatitis B e Antigen (HBeAg)-positive CHB will remain on their current OAV and receive selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants will continue their current OAV therapy 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
Tablet(s) administered orally once weekly
Hepatitis B virus (HBV) OAV Therapy
Commercially available HBV OAV therapy could include one of the following:
Tenofovir disoproxil fumarate (TDF; Viread®) Entecavir (Baraclude®) Adefovir (Hepsera®) Lamivudine (Epivir® ) Telbivudine (Tyzeka®) Tenofovir alafenamide (TAF; Vemlidy®)
Selgantolimod 3 mg: HBeAg-negative CHB Participants
Participants with HBeAg-negative CHB will remain on their current OAV and receive selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants will continue their current OAV therapy 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.
Selgantolimod
Tablet(s) administered orally once weekly
Hepatitis B virus (HBV) OAV Therapy
Commercially available HBV OAV therapy could include one of the following:
Tenofovir disoproxil fumarate (TDF; Viread®) Entecavir (Baraclude®) Adefovir (Hepsera®) Lamivudine (Epivir® ) Telbivudine (Tyzeka®) Tenofovir alafenamide (TAF; Vemlidy®)
Selgantolimod 1.5 mg: HBeAg-positive CHB Participants
Participants with HBeAg-positive CHB will remain on their current OAV and receive selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants will continue their current OAV therapy 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.
Selgantolimod
Tablet(s) administered orally once weekly
Placebo
Placebo to match (PTM) selgantolimod tablet(s) administered orally once weekly
Hepatitis B virus (HBV) OAV Therapy
Commercially available HBV OAV therapy could include one of the following:
Tenofovir disoproxil fumarate (TDF; Viread®) Entecavir (Baraclude®) Adefovir (Hepsera®) Lamivudine (Epivir® ) Telbivudine (Tyzeka®) Tenofovir alafenamide (TAF; Vemlidy®)
Selgantolimod 1.5 mg: HBeAg-negative CHB Participants
Participants with HBeAg-negative CHB will remain on their current OAV and receive selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants will continue their current OAV therapy 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.
Selgantolimod
Tablet(s) administered orally once weekly
Placebo
Placebo to match (PTM) selgantolimod tablet(s) administered orally once weekly
Hepatitis B virus (HBV) OAV Therapy
Commercially available HBV OAV therapy could include one of the following:
Tenofovir disoproxil fumarate (TDF; Viread®) Entecavir (Baraclude®) Adefovir (Hepsera®) Lamivudine (Epivir® ) Telbivudine (Tyzeka®) Tenofovir alafenamide (TAF; Vemlidy®)
Placebo: HBeAg-positive CHB Participants
Participants with HBeAg-positive CHB will remain on their current OAV and receive 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants will continue their current OAV therapy 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
Placebo to match (PTM) selgantolimod tablet(s) administered orally once weekly
Hepatitis B virus (HBV) OAV Therapy
Commercially available HBV OAV therapy could include one of the following:
Tenofovir disoproxil fumarate (TDF; Viread®) Entecavir (Baraclude®) Adefovir (Hepsera®) Lamivudine (Epivir® ) Telbivudine (Tyzeka®) Tenofovir alafenamide (TAF; Vemlidy®)
Placebo: HBeAg-negative CHB Participants
Participants with HBeAg-negative CHB will remain on their current OAV and receive 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants will continue their current OAV therapy 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
Placebo to match (PTM) selgantolimod tablet(s) administered orally once weekly
Hepatitis B virus (HBV) OAV Therapy
Commercially available HBV OAV therapy could include one of the following:
Tenofovir disoproxil fumarate (TDF; Viread®) Entecavir (Baraclude®) Adefovir (Hepsera®) Lamivudine (Epivir® ) Telbivudine (Tyzeka®) Tenofovir alafenamide (TAF; Vemlidy®)
Interventions
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Selgantolimod
Tablet(s) administered orally once weekly
Placebo
Placebo to match (PTM) selgantolimod tablet(s) administered orally once weekly
Hepatitis B virus (HBV) OAV Therapy
Commercially available HBV OAV therapy could include one of the following:
Tenofovir disoproxil fumarate (TDF; Viread®) Entecavir (Baraclude®) Adefovir (Hepsera®) Lamivudine (Epivir® ) Telbivudine (Tyzeka®) Tenofovir alafenamide (TAF; Vemlidy®)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Adult males and non-pregnant, non-lactating females
* Documented evidence of chronic HBV infection with detectable hepatitis B surface antigen (HBsAg) levels
* On commercially available HBV OAV treatment(s) for at least 6 months with no change in regimen for 3 months prior to screening
* HBV Deoxyribonucleic acid (DNA) ≤ 20 IU/mL for 6 or more months prior to screening
* Screening Electrocardiogram (ECG) without clinically significant abnormalities
Exclusion Criteria
* Adults meeting any of the protocol defined exclusionary laboratory parameters at screening:
* Alanine aminotransferase (ALT) \> 3x Upper Limit of Normal (ULN)
* International normalized ratio (INR) \> ULN unless the adult is stable on an anticoagulant regimen
* Albumin \< 3.5 g/dL
* Direct bilirubin \> 1.5x ULN
* Platelet Count \< 100,000/uL
* Estimated creatinine clearance \< 60 mL/min (using the Cockcroft-Gault method)
* Co-infection with human immunodeficiency virus, hepatitis C virus or hepatitis D virus
* Prior history of hepatocellular carcinoma (HCC) 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
* Received prolonged therapy with immunomodulators or biologics within 3 months of screening
* Use of another investigational agent within 90 days of screening, unless allowed by the Sponsor
18 Years
65 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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University of Maryland, Institute of Human Virology
Baltimore, Maryland, United States
Auckland Clinical Studies Limited
Auckland, , New Zealand
Countries
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References
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Brooks AE, Verdon D, Eom J, Ng J, Steemson H, Lau AH, et al. Peripheral Immune Responses to Toll-Like Receptor 8 Agonist Selgantolimod (GS-9688) in Patients with Chronic Hepatitis B [Poster]. AASLD: The Liver Meeting® 2019; 2019 08-12 November; Boston, MA.
Gane E, Zhao Y, Tan SK, Lau AH, Gaggar A, Subramanian M, et al. Efficacy and Safety of Oral TLR8 Agonist Selgantolimod in Virally Suppressed Adult Patients With Chronic Hepatitis B: a Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study [Poster 697]. AASLD: The Liver Meeting® 2019; 2019 08-12 November; Boston, MA.
Chen DY, C. M, Tan SK, Yang JC, Gane EJ, Janssen HLA, et al. Characterization of Cytokine Response to Toll-Like Receptor 8 Agonist Selgantolimod in Viremic and Virally Suppressed Chronic Hepatitis B Patients [Poster 0721]. American Association for the Study of Liver Diseases (AASLD): The Liver Meeting Digital Experience; 2020 13-16 November.
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 FR1350]. The Digital International Liver Congress (ILC); 2020 27-29 August.
Gane E, Dubar PR, Brooks AE, Zhao Y, Tan SK, Lau AH, et al. Efficacy and Safety of 24 Weeks Treatment with Oral TLR8 Agonist Selgantolimod (GS-9688, SLGN) in Virally Suppressed Adult Patients with Chronic Hepatitis B: A Phase 2 Study [Presentation]. The Digital International Liver Congress (ILC); 2020 27-29 August.
Gane EJ, Dunbar PR, Brooks AE, Zhang F, Chen D, Wallin JJ, van Buuren N, Arora P, Fletcher SP, Tan SK, Yang JC, Gaggar A, Kottilil S, Tang L. Safety and efficacy of the oral TLR8 agonist selgantolimod in individuals with chronic hepatitis B under viral suppression. J Hepatol. 2023 Mar;78(3):513-523. doi: 10.1016/j.jhep.2022.09.027. Epub 2022 Oct 29.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan: Week 24 Analysis and Final Analysis
Document Type: Statistical Analysis Plan: TFFU (Treatment-Free Follow-Up) Analysis
Other Identifiers
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ACTRN12618000143224p
Identifier Type: REGISTRY
Identifier Source: secondary_id
GS-US-389-2024
Identifier Type: -
Identifier Source: org_study_id
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