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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03491553
Registration number
NCT03491553
Ethics application status
Date submitted
2/04/2018
Date registered
9/04/2018
Date last updated
19/08/2021
Titles & IDs
Public title
Safety, Tolerability and Antiviral Activity of Selgantolimod in Virally-Suppressed Participants With Chronic Hepatitis B
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Scientific 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
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Secondary ID [1]
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ACTRN12618000143224p
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Secondary ID [2]
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GS-US-389-2024
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Hepatitis B
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Condition category
Condition code
Infection
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Other infectious diseases
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Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Selgantolimod
Treatment: Drugs - Placebo
Treatment: Drugs - Hepatitis B virus (HBV) OAV Therapy
Experimental: 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.
Experimental: 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.
Experimental: 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.
Experimental: 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.
Experimental: 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.
Experimental: 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.
Treatment: Drugs: Selgantolimod
Tablet(s) administered orally once weekly
Treatment: Drugs: Placebo
Placebo to match (PTM) selgantolimod tablet(s) administered orally once weekly
Treatment: Drugs: 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®)
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants With = 1 log10 IU/mL Decline in Serum Quantitative Hepatitis B Surface Antigen (qHBsAg) From Baseline at Week 24
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Assessment method [1]
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Timepoint [1]
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Week 24
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Secondary outcome [1]
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Percentage of Participants With = 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 4
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Assessment method [1]
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Timepoint [1]
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Week 4
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Secondary outcome [2]
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Percentage of Participants With = 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 8
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Assessment method [2]
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Timepoint [2]
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Week 8
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Secondary outcome [3]
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Percentage of Participants With = 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 12
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Assessment method [3]
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Timepoint [3]
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Week 12
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Secondary outcome [4]
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Percentage of Participants With = 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 48
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Assessment method [4]
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Timepoint [4]
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Week 48
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Secondary outcome [5]
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Change From Baseline in Serum qHBsAg at Week 4
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Assessment method [5]
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Timepoint [5]
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Baseline, Week 4
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Secondary outcome [6]
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Change From Baseline in Serum qHBsAg (log10 IU/mL) at Week 8
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Assessment method [6]
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Timepoint [6]
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Baseline, Week 8
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Secondary outcome [7]
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Change From Baseline in Serum qHBsAg (log10 IU/mL) at Week 12
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Assessment method [7]
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Timepoint [7]
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Baseline, Week 12
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Secondary outcome [8]
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Change From Baseline in Serum qHBsAg (log10 IU/mL) at Week 24
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Assessment method [8]
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Timepoint [8]
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Baseline, Week 24
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Secondary outcome [9]
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Change From Baseline in Serum qHBsAg (log10 IU/mL) at Week 48
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Assessment method [9]
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Timepoint [9]
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Baseline, Week 48
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Secondary outcome [10]
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Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 12
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Assessment method [10]
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HBsAg loss was defined as qualitative HBsAg changing from positive at baseline to negative at a postbaseline visit.
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Timepoint [10]
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Week 12
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Secondary outcome [11]
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Percentage of Participants With HBsAg Loss at Week 24
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Assessment method [11]
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HBsAg loss was defined as qualitative HBsAg changing from positive at baseline to negative at a postbaseline visit.
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Timepoint [11]
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Week 24
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Secondary outcome [12]
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Percentage of Participants With HBsAg Loss at Week 48
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Assessment method [12]
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HBsAg loss was defined as qualitative HBsAg changing from positive at baseline to negative at a postbaseline visit.
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Timepoint [12]
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Week 48
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Secondary outcome [13]
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Percentage of Participants With HBeAg Loss and Seroconversion at Week 12
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Assessment method [13]
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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.
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Timepoint [13]
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Week 12
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Secondary outcome [14]
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Percentage of Participants With HBeAg Loss and Seroconversion at Week 24
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Assessment method [14]
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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.
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Timepoint [14]
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Week 24
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Secondary outcome [15]
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Percentage of Participants With HBeAg Loss and Seroconversion at Week 48
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Assessment method [15]
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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) test changing from negative or missing at baseline to positive at a postbaseline visit.
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Timepoint [15]
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Week 48
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Secondary outcome [16]
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Percentage of Participants With Virologic Breakthrough
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Assessment method [16]
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Virologic breakthrough was defined as having two consecutive visits of hepatitis B virus (HBV) deoxyribonucleic acid (DNA) = 69 IU/mL.
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Timepoint [16]
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Baseline up to Week 48
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Secondary outcome [17]
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Percentage of Participants With Drug Resistance Mutations
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Assessment method [17]
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The criteria for a drug resistance mutation was having two consecutive visits of HBV DNA = 69 IU/mL.
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Timepoint [17]
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Baseline up to Week 48
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Eligibility
Key inclusion criteria
Key
- 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 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
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
6/04/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
10/08/2020
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Sample size
Target
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Accrual to date
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Final
48
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Maryland
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Country [2]
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New Zealand
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State/province [2]
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Auckland
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Gilead Sciences
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The primary objectives of this study are to evaluate the safety, tolerability and antiviral
activity of selgantolimod (formerly GS-9688) in virally suppressed chronic hepatitis B (CHB)
adults on oral antiviral (OAV) agents.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03491553
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Gilead Study Director
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Address
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Gilead Sciences
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03491553
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