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Safety, Tolerability and Antiviral Activity of Selgantolimod in Virally-Suppressed Adults With Chronic Hepatitis B

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03491553
Recruitment Status : Active, not recruiting
First Posted : April 9, 2018
Last Update Posted : October 2, 2019
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Brief Summary:
The primary objectives of this study are to evaluate the safety, tolerability and antiviral activity of multiple oral doses of selgantolimod (formerly GS-9688) in virally suppressed chronic hepatitis B (CHB) adults on oral antiviral (OAV) agents.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis B Drug: selgantolimod Drug: Placebo Drug: OAV Therapy Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: 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 Virally-Suppressed Adult Subjects With Chronic Hepatitis B
Actual Study Start Date : April 6, 2018
Actual Primary Completion Date : March 22, 2019
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Hepatitis B e antigen (HBeAg)-positive CHB, Placebo
Participants will remain on their current OAV and receive placebo for 24 doses. After the 24th dose, participants will continue on their current OAV therapy until Week 48/Early Discontinuation (ED). The total study duration for each participant will be 48 weeks with up to an additional 48 weeks if continued into the Treatment Free Follow-up (TFFU) phase.
Drug: Placebo
Placebo to match (PTM) selgantolimod tablet(s) administered orally once weekly

Drug: OAV Therapy
Commercially available HBV OAV treatment(s)

Experimental: HBeAg-positive CHB, selgantolimod 1.5 mg
Participants will remain on their current OAV and receive selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus placebo for 24 doses. After the 24th dose, participants will continue on their current OAV therapy until Week 48/ED. The total study duration for each participant will be 48 weeks with up to an additional 48 weeks if continued into the TFFU phase.
Drug: selgantolimod
Tablet(s) administered orally once weekly
Other Name: GS-9688

Drug: Placebo
Placebo to match (PTM) selgantolimod tablet(s) administered orally once weekly

Drug: OAV Therapy
Commercially available HBV OAV treatment(s)

Experimental: HBeAg-positive CHB, selgantolimod 3 mg
Participants will remain on their current OAV and receive selgantolimod 3 mg (2 x 1.5 mg tablet) for 24 doses. After the 24th dose, participants will continue on their current OAV therapy until Week 48/ED. The total study duration for each participant will be 48 weeks with up to an additional 48 weeks if continued into the TFFU phase.
Drug: selgantolimod
Tablet(s) administered orally once weekly
Other Name: GS-9688

Drug: OAV Therapy
Commercially available HBV OAV treatment(s)

Experimental: HBeAg-negative CHB, Placebo
Participants will remain on their current OAV and receive placebo for 24 doses. After the 24th dose, participants will continue on their current OAV therapy until Week 48/ED. The total study duration for each participant will be 48 weeks with up to an additional 48 weeks if continued into the TFFU phase.
Drug: Placebo
Placebo to match (PTM) selgantolimod tablet(s) administered orally once weekly

Drug: OAV Therapy
Commercially available HBV OAV treatment(s)

Experimental: HBeAg-negative CHB, selgantolimod 1.5 mg
Participants will remain on their current OAV and receive selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus placebo for 24 doses. After the 24th dose, participants will continue on their current OAV therapy until Week 48/ED. The total study duration for each participant will be 48 weeks with up to an additional 48 weeks if continued into the TFFU phase.
Drug: selgantolimod
Tablet(s) administered orally once weekly
Other Name: GS-9688

Drug: Placebo
Placebo to match (PTM) selgantolimod tablet(s) administered orally once weekly

Drug: OAV Therapy
Commercially available HBV OAV treatment(s)

Experimental: HBeAg-negative CHB, selgantolimod 3 mg
Participants will remain on their current OAV and receive selgantolimod 3 mg (2 x 1.5 mg tablet) for 24 doses. After the 24th dose, participants will continue on their current OAV therapy until Week 48/ED. The total study duration for each participant will be 48 weeks with up to an additional 48 weeks if continued into the TFFU phase.
Drug: selgantolimod
Tablet(s) administered orally once weekly
Other Name: GS-9688

Drug: OAV Therapy
Commercially available HBV OAV treatment(s)




Primary Outcome Measures :
  1. Proportion of Participants With ≥ 1 Log10 IU/mL Decline in Serum Quantitative Hepatitis B Surface Antigen (qHBsAg) From Baseline at Week 24 [ Time Frame: Baseline to Week 24 ]

Secondary Outcome Measures :
  1. Proportion of Participants With ≥ 1 Log10 IU/mL Decline in qHBsAg From Baseline at Week 4 [ Time Frame: Baseline to Week 4 ]
  2. Proportion of Participants With ≥ 1 Log10 IU/mL Decline in qHBsAg From Baseline at Week 8 [ Time Frame: Baseline to Week 8 ]
  3. Proportion of Participants With ≥ 1 Log10 IU/mL Decline in qHBsAg From Baseline at Week 12 [ Time Frame: Baseline to Week 12 ]
  4. Proportion of Participants With ≥ 1 Log10 IU/mL Decline in qHBsAg From Baseline at Week 48 [ Time Frame: Baseline to Week 48 ]
  5. Change in qHBsAg (log10 IU/mL) From Baseline at Week 4 [ Time Frame: Baseline to Week 4 ]
  6. Change in qHBsAg (log10 IU/mL) From Baseline at Week 8 [ Time Frame: Baseline to Week 8 ]
  7. Change in qHBsAg (log10 IU/mL) From Baseline at Week 12 [ Time Frame: Baseline to Week 12 ]
  8. Change in qHBsAg (log10 IU/mL) From Baseline at Week 24 [ Time Frame: Baseline to Week 24 ]
  9. Change in qHBsAg (log10 IU/mL) From Baseline at Week 48 [ Time Frame: Baseline to Week 48 ]
  10. Proportion of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 12 [ Time Frame: Baseline to Week 12 ]
    HBsAg loss is defined as HBsAg changing from positive at baseline to negative at a postbaseline visit.

  11. Proportion of Participants With HBsAg Loss at Week 24 [ Time Frame: Baseline to Week 24 ]
    HBsAg loss is defined as HBsAg changing from positive at baseline to negative at a postbaseline visit.

  12. Proportion of Participants With HBsAg Loss at Week 48 [ Time Frame: Baseline to Week 48 ]
    HBsAg loss is defined as HBsAg changing from positive at baseline to negative at a postbaseline visit.

  13. Proportion of Participants With HBeAg Loss at Week 12 [ Time Frame: Baseline to Week 12 ]
    HBeAg loss is defined as HBeAg changing from positive at baseline to negative at a postbaseline visit.

  14. Proportion of Participants With HBeAg Loss at Week 24 [ Time Frame: Baseline to Week 24 ]
    HBeAg loss is defined as HBeAg changing from positive at baseline to negative at a postbaseline visit.

  15. Proportion of Participants With HBeAg Loss at Week 48 [ Time Frame: Baseline to Week 48 ]
    HBeAg loss is defined as HBeAg changing from positive at baseline to negative at a postbaseline visit.

  16. Proportion of Participants With HBeAg Seroconversion at Week 12 [ Time Frame: Baseline to Week 12 ]
    HBeAg seroconversion is defined as HBeAg loss and HBeAb test changing from negative or missing at baseline to positive at a postbaseline visit.

  17. Proportion of Participants With HBeAg Seroconversion at Week 24 [ Time Frame: Baseline to Week 24 ]
    HBeAg seroconversion is defined as HBeAg loss and HBeAb test changing from negative or missing at baseline to positive at a postbaseline visit.

  18. Proportion of Participants With HBeAg Seroconversion at Week 48 [ Time Frame: Baseline to Week 48 ]
    HBeAg seroconversion is defined as HBeAg loss and HBeAb test changing from negative or missing at baseline to positive at a postbaseline visit.

  19. Proportion of Participants with Virologic Breakthrough [ Time Frame: Up to 48 Weeks ]
    Virologic breakthrough is defined as two consecutive visits of hepatitis B virus (HBV) deoxyribonucleic acid (DNA) ≥ 69 IU/mL

  20. Proportion of Participants With Drug Resistance Mutations [ Time Frame: Up to 48 Weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 males and non-pregnant, non-lactating females
  • Documented evidence of chronic HBV infection with detectable 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

Key Exclusion Criteria:

  • Extensive bridging fibrosis or cirrhosis
  • 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

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03491553


Locations
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United States, Maryland
University of Maryland, Institute of Human Virology
Baltimore, Maryland, United States, 21201
New Zealand
Auckland Clinical Studies Limited
Auckland, New Zealand, 1010
Sponsors and Collaborators
Gilead Sciences
Investigators
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Study Director: Gilead Study Director Gilead Sciences

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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT03491553    
Other Study ID Numbers: GS-US-389-2024
ACTRN12618000143224p ( Registry Identifier: ANZCTR )
First Posted: April 9, 2018    Key Record Dates
Last Update Posted: October 2, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Antiviral Agents
Anti-Infective Agents