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Completed

NCT Number: NCT03615066

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

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.

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Key information

Conditions

Chronic Hepatitis B Blood-Borne Infections Chronic Disease Communicable Diseases DNA Virus Infections Digestive System Diseases Disease Attributes Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis B, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Calgary Liver Unit - Heritage Medical Research Clinic, Calgary, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo

Drug

Tablet(s) administered orally every 7 days for 24 doses in fasted state

Selgantolimod

Drug

Tablet(s) administered orally every 7 days for 24 doses in fasted state

Other names: GS-9688

TAF

Drug

Tablet(s) administered orally once daily with food

Other names: Vemlidy®

Primary outcomes

  1. 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

  2. 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.

  3. 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.

Secondary outcomes

  1. Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 4

    Time frame: Baseline, Week 4

  2. Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 8

    Time frame: Baseline, Week 8

  3. Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 12

    Time frame: Baseline, Week 12

  4. Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 48

    Time frame: Baseline, Week 48

  5. Change From Baseline in Serum qHBsAg at Week 4

    Time frame: Baseline, Week 4

  6. Change From Baseline in Serum qHBsAg at Week 8

    Time frame: Baseline, Week 8

  7. Change From Baseline in Serum qHBsAg at Week 12

    Time frame: Baseline, Week 12

  8. Change From Baseline in Serum qHBsAg at Week 24

    Time frame: Baseline, Week 24

  9. Change From Baseline in Serum qHBsAg at Week 48

    Time frame: Baseline, Week 48

  10. Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) < Lower Limit of Quantification (LLOQ) at Week 12

    Time frame: Week 12

    LLOQ was defined as 20 IU/mL.

  11. Percentage of Participants With HBV DNA < LLOQ at Week 24

    Time frame: Week 24

    LLOQ was defined as 20 IU/mL.

  12. Percentage of Participants With HBV DNA < LLOQ at Week 48

    Time frame: Week 48

    LLOQ was defined as 20 IU/mL.

  13. Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 12

    Time frame: Week 12

    HBsAg loss was defined as qualitative HBsAg changing from positive at baseline to negative at a postbaseline visit.

  14. Percentage of Participants With HBsAg Loss at Week 24

    Time frame: Week 24

    HBsAg loss was defined as qualitative HBsAg changing from positive at baseline to negative at a postbaseline visit.

  15. Percentage of Participants With HBsAg Loss at Week 48

    Time frame: Week 48

    HBsAg loss was defined as qualitative HBsAg changing from positive at baseline to negative at a postbaseline visit.

  16. Percentage of Participants With HBeAg Loss and Seroconversion at Week 12

    Time frame: 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.

  17. Percentage of Participants With HBeAg Loss and Seroconversion at Week 24

    Time frame: 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.

  18. Percentage of Participants With HBeAg Loss and Seroconversion at Week 48

    Time frame: 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.

  19. Percentage of Participants With Virologic Breakthrough From Baseline up to Week 24

    Time frame: 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.

  20. Percentage of Participants With Virologic Breakthrough From Baseline up to Week 48

    Time frame: 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.

  21. Percentage of Participants With Drug Resistance Mutations

    Time frame: Baseline up to Week 48

  22. 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

    AUClast is defined as the concentration of drug from time zero to the last observable concentration.

  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

    AUC0-24 is defined as the concentration of drug over time from time zero to time 24 hours.

  24. 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

    AUC0-inf is defined as the concentration of drug over time from time zero to infinity.

  25. 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

    Cmax is defined as the maximum concentration of drug.

  26. 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

    Tmax is defined as the time (observed time point) of Cmax.

  27. 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

    CL/F is defined as the apparent oral clearance following administration of the drug.

  28. 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

    t1/2 is defined as the estimate of the terminal elimination half-life of the drug.

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2021
First posted
Aug 3, 2018
Registry last updated
May 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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