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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/NCT04891770
Registration number
NCT04891770
Ethics application status
Date submitted
14/05/2021
Date registered
18/05/2021
Date last updated
13/02/2024
Titles & IDs
Public title
Study to Evaluate the Safety and Efficacy of Selgantolimod (SLGN)-Containing Combination Therapies for the Treatment of Chronic Hepatitis B (CHB)
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Scientific title
A Phase 2a, Open-Label Study to Evaluate the Safety and Efficacy of Selgantolimod (SLGN)-Containing Combination Therapies for the Treatment of Chronic Hepatitis B (CHB)
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Secondary ID [1]
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2021-000672-11
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Secondary ID [2]
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GS-US-465-4439
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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 - Tenofovir Alafenamide
Treatment: Drugs - VIR-2218
Treatment: Drugs - Nivolumab
Treatment: Drugs - Selgantolimod
Experimental: Cohort 1: TAF + VIR-2218 + SLGN + Nivolumab - Nucleos(t)ide(s) (NUC)-suppressed participants with chronic hepatitis B (CHB) will receive:
Tenofovir alafenamide (TAF) 25 mg once daily for 36 weeks (up to 84 weeks).
VIR-2218 200 mg once every 4 weeks for 24 weeks.
At Week 12 the following will be added:
Selgantolimod (SLGN) 3 mg once a week on the same day for 24 weeks.
Nivolumab 0.3 mg/kg once every 4 weeks for up to 24 weeks (Up to protocol amendment 2).
Participants who are on TAF treatment will continue TAF treatment over the duration of study follow-up.
After the implementation of protocol amendment 2, nivolumab treatment was no longer administered.
Experimental: Cohort 2 Group A: VIR-2218 + SLGN + Nivolumab - Viremic participants with CHB will receive:
VIR-2218 200 mg once every 4 weeks for 24 weeks.
At Week 12, the following will be added:
SLGN 3 mg once a week on the same day for 24 weeks
Nivolumab 0.3 mg/kg once every 4 weeks for up to 24 weeks (Up to protocol amendment 2).
Viremic participants who meet criteria to initiate NUC treatment will receive TAF 25 mg once daily for up to 36 weeks during the study.
After the implementation of protocol amendment 2, nivolumab treatment was no longer administered.
Experimental: Cohort 2 Group B: SLGN + Nivolumab - Viremic participants with CHB will receive:
SLGN 3 mg once a week on the same day for 24 weeks.
Nivolumab 0.3 mg/kg once every 4 weeks for up to 24 weeks.
Viremic participants who meet criteria to initiate NUC treatment will receive TAF 25 mg once daily for up to 36 weeks during the study.
Cohort 2 Group B, all treatments were administered up to protocol amendment 2 and after the implementation of protocol amendment 2, the treatments were discontinued based on Sponsor decision due to low likelihood of efficacy.
Treatment: Drugs: Tenofovir Alafenamide
Administered as film-coated oral tablets
Treatment: Drugs: VIR-2218
Administered as a sub-cutaneous (SC) injection
Treatment: Drugs: Nivolumab
Administered intravenously
Treatment: Drugs: Selgantolimod
Administered as film-coated oral tablets
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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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Proportion of Participants Who Achieve Functional Cure
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Assessment method [1]
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Functional cure is defined as hepatitis B surface antigen (HBsAg) loss and hepatitis B virus (HBV) DNA < lower limit of quantitation (LLOQ)
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Timepoint [1]
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Up to Week 60
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Secondary outcome [1]
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Proportion of Participants With Hepatitis B Surface Antigen (HBsAg) Loss With and Without Anti-HBsAg Seroconversion
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Assessment method [1]
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Timepoint [1]
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Up to 84 Weeks
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Secondary outcome [2]
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Proportion of Participants With Hepatitis B e Antigen (HBeAg) Loss With and Without Anti-HBeAg Seroconversion in Participants With CHB Who Are HBeAg-Positive at Baseline
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Assessment method [2]
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Timepoint [2]
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Up to 84 Weeks
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Secondary outcome [3]
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Proportion of Participants Who Remain Off Nucleos(t)ide(s) (NUC) Treatment During Follow-Up
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Assessment method [3]
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Timepoint [3]
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Week 36 up to Week 84
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Secondary outcome [4]
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Proportion of Participants Experiencing Hepatitis B Virus (HBV) Virologic Breakthrough
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Assessment method [4]
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Virologic breakthrough is defined as confirmed HBV DNA = LLOQ after 2 consecutive HBV DNA < LLOQ in participants who are complying with NUC therapy or confirmed HBV DNA = 1 log10 IU/mL increase from nadir.
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Timepoint [4]
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Up to 36 Weeks
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Eligibility
Key inclusion criteria
Key
- Willing and able to provide informed consent
- Chronic HBV infection for at least 6 months
- Willing to follow protocol-specified contraception requirement
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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
- Have extensive fibrosis or cirrhosis in the liver
- Have or had liver cancer (hepatocellular carcinoma)
- Have an autoimmune disease
- Have chronic liver disease other than HBV
- Females who are breastfeeding, pregnant, or who wish to become pregnant during the
study
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
Open (masking not used)
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Who is / are masked / blinded?
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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
Active, not recruiting
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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
14/08/2021
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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
1/07/2024
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Actual
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Sample size
Target
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Accrual to date
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Final
103
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Liverpool Hospital - Liverpool
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Recruitment hospital [2]
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Royal Melbourne Hospital - Parkville
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Recruitment postcode(s) [1]
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2170 - Liverpool
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Recruitment postcode(s) [2]
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3050 - Parkville
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Recruitment outside Australia
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Denmark
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State/province [1]
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Aalborg
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Denmark
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Aarhus N
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Denmark
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Hvidovre
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Denmark
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Odense
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Country [5]
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Hong Kong
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Hong Kong
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Hong Kong
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Shatin
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Hong Kong
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State/province [7]
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Tai Po
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Country [8]
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Korea, Republic of
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State/province [8]
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Seoul
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New Zealand
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State/province [9]
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Grafton
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Singapore
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State/province [10]
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Singapore
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Thailand
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State/province [11]
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Bangkok
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Thailand
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Muang
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United Kingdom
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State/province [13]
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London
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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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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Vir Biotechnology, Inc.
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Address [1]
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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 and tolerability of study
treatment(s) (selgantolimod-containing combination therapies) and to evaluate the efficacy of
study treatment(s) as measured by the proportion of participants who achieve functional cure,
defined as hepatitis B surface antigen (HBsAg) loss and hepatitis B virus
(HBV)deoxyribonucleic acid (DNA) < lower limit of quantitation (LLOQ) at Follow-up (FU) Week
24 in participants with chronic hepatitis B (CHB).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04891770
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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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Phone
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Fax
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Email
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Contact person for public queries
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Address
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04891770
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