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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04891770




Registration number
NCT04891770
Ethics application status
Date submitted
14/05/2021
Date registered
18/05/2021

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)
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)
Secondary ID [1] 0 0
2021-000672-11
Secondary ID [2] 0 0
GS-US-465-4439
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 - 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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of Participants Who Achieve Functional Cure
Assessment method [1] 0 0
Functional cure is defined as hepatitis B surface antigen (HBsAg) loss and hepatitis B virus (HBV) DNA \< lower limit of quantitation (LLOQ)
Timepoint [1] 0 0
Up to Week 60
Secondary outcome [1] 0 0
Proportion of Participants With Hepatitis B Surface Antigen (HBsAg) Loss With and Without Anti-HBsAg Seroconversion
Assessment method [1] 0 0
Timepoint [1] 0 0
Up to 84 Weeks
Secondary outcome [2] 0 0
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
Assessment method [2] 0 0
Timepoint [2] 0 0
Up to 84 Weeks
Secondary outcome [3] 0 0
Proportion of Participants Who Remain Off Nucleos(t)ide(s) (NUC) Treatment During Follow-Up
Assessment method [3] 0 0
Timepoint [3] 0 0
Week 36 up to Week 84
Secondary outcome [4] 0 0
Proportion of Participants Experiencing Hepatitis B Virus (HBV) Virologic Breakthrough
Assessment method [4] 0 0
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.
Timepoint [4] 0 0
Up to 36 Weeks

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

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

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/08/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
19/07/2024
Sample size
Target
Accrual to date
Final
103
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 0 0
Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
2170 - Liverpool
Recruitment postcode(s) [2] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
Denmark
State/province [1] 0 0
Aalborg
Country [2] 0 0
Denmark
State/province [2] 0 0
Aarhus N
Country [3] 0 0
Denmark
State/province [3] 0 0
Hvidovre
Country [4] 0 0
Denmark
State/province [4] 0 0
Odense
Country [5] 0 0
Hong Kong
State/province [5] 0 0
Hong Kong
Country [6] 0 0
Hong Kong
State/province [6] 0 0
Shatin
Country [7] 0 0
Hong Kong
State/province [7] 0 0
Tai Po
Country [8] 0 0
Korea, Republic of
State/province [8] 0 0
Seoul
Country [9] 0 0
New Zealand
State/province [9] 0 0
Grafton
Country [10] 0 0
Singapore
State/province [10] 0 0
Singapore
Country [11] 0 0
Thailand
State/province [11] 0 0
Bangkok
Country [12] 0 0
Thailand
State/province [12] 0 0
Muang
Country [13] 0 0
United Kingdom
State/province [13] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Gilead Sciences
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Vir Biotechnology, Inc.
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

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

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04891770