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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03491553




Registration number
NCT03491553
Ethics application status
Date submitted
2/04/2018
Date registered
9/04/2018
Date last updated
2/10/2019

Titles & IDs
Public title
Safety, Tolerability and Antiviral Activity of Selgantolimod in Virally-Suppressed Adults With Chronic Hepatitis B
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
Secondary ID [1] 0 0
ACTRN12618000143224p
Secondary ID [2] 0 0
GS-US-389-2024
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Hepatitis B 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - selgantolimod
Treatment: Drugs - Placebo
Treatment: Drugs - OAV Therapy

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.

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.

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.

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.

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.

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.


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: OAV Therapy
Commercially available HBV OAV treatment(s)

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of Participants With = 1 Log10 IU/mL Decline in Serum Quantitative Hepatitis B Surface Antigen (qHBsAg) From Baseline at Week 24
Timepoint [1] 0 0
Baseline to Week 24
Secondary outcome [1] 0 0
Proportion of Participants With = 1 Log10 IU/mL Decline in qHBsAg From Baseline at Week 4
Timepoint [1] 0 0
Baseline to Week 4
Secondary outcome [2] 0 0
Proportion of Participants With = 1 Log10 IU/mL Decline in qHBsAg From Baseline at Week 8
Timepoint [2] 0 0
Baseline to Week 8
Secondary outcome [3] 0 0
Proportion of Participants With = 1 Log10 IU/mL Decline in qHBsAg From Baseline at Week 12
Timepoint [3] 0 0
Baseline to Week 12
Secondary outcome [4] 0 0
Proportion of Participants With = 1 Log10 IU/mL Decline in qHBsAg From Baseline at Week 48
Timepoint [4] 0 0
Baseline to Week 48
Secondary outcome [5] 0 0
Change in qHBsAg (log10 IU/mL) From Baseline at Week 4
Timepoint [5] 0 0
Baseline to Week 4
Secondary outcome [6] 0 0
Change in qHBsAg (log10 IU/mL) From Baseline at Week 8
Timepoint [6] 0 0
Baseline to Week 8
Secondary outcome [7] 0 0
Change in qHBsAg (log10 IU/mL) From Baseline at Week 12
Timepoint [7] 0 0
Baseline to Week 12
Secondary outcome [8] 0 0
Change in qHBsAg (log10 IU/mL) From Baseline at Week 24
Timepoint [8] 0 0
Baseline to Week 24
Secondary outcome [9] 0 0
Change in qHBsAg (log10 IU/mL) From Baseline at Week 48
Timepoint [9] 0 0
Baseline to Week 48
Secondary outcome [10] 0 0
Proportion of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 12 - HBsAg loss is defined as HBsAg changing from positive at baseline to negative at a postbaseline visit.
Timepoint [10] 0 0
Baseline to Week 12
Secondary outcome [11] 0 0
Proportion of Participants With HBsAg Loss at Week 24 - HBsAg loss is defined as HBsAg changing from positive at baseline to negative at a postbaseline visit.
Timepoint [11] 0 0
Baseline to Week 24
Secondary outcome [12] 0 0
Proportion of Participants With HBsAg Loss at Week 48 - HBsAg loss is defined as HBsAg changing from positive at baseline to negative at a postbaseline visit.
Timepoint [12] 0 0
Baseline to Week 48
Secondary outcome [13] 0 0
Proportion of Participants With HBeAg Loss at Week 12 - HBeAg loss is defined as HBeAg changing from positive at baseline to negative at a postbaseline visit.
Timepoint [13] 0 0
Baseline to Week 12
Secondary outcome [14] 0 0
Proportion of Participants With HBeAg Loss at Week 24 - HBeAg loss is defined as HBeAg changing from positive at baseline to negative at a postbaseline visit.
Timepoint [14] 0 0
Baseline to Week 24
Secondary outcome [15] 0 0
Proportion of Participants With HBeAg Loss at Week 48 - HBeAg loss is defined as HBeAg changing from positive at baseline to negative at a postbaseline visit.
Timepoint [15] 0 0
Baseline to Week 48
Secondary outcome [16] 0 0
Proportion of Participants With HBeAg Seroconversion at 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.
Timepoint [16] 0 0
Baseline to Week 12
Secondary outcome [17] 0 0
Proportion of Participants With HBeAg Seroconversion at 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.
Timepoint [17] 0 0
Baseline to Week 24
Secondary outcome [18] 0 0
Proportion of Participants With HBeAg Seroconversion at 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.
Timepoint [18] 0 0
Baseline to Week 48
Secondary outcome [19] 0 0
Proportion of Participants with Virologic Breakthrough - Virologic breakthrough is defined as two consecutive visits of hepatitis B virus (HBV) deoxyribonucleic acid (DNA) = 69 IU/mL
Timepoint [19] 0 0
Up to 48 Weeks
Secondary outcome [20] 0 0
Proportion of Participants With Drug Resistance Mutations
Timepoint [20] 0 0
Up to 48 Weeks

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 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
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Maryland
Country [2] 0 0
New Zealand
State/province [2] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Gilead Sciences
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT03491553
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gilead Study Director
Address 0 0
Gilead Sciences
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications