search
Back to results

Study to Evaluate the Safety and Efficacy of Selgantolimod (SLGN)-Containing Combination Therapies for the Treatment of Chronic Hepatitis B (CHB)

Primary Purpose

Chronic Hepatitis B

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Tenofovir Alafenamide
VIR-2218
Nivolumab
Selgantolimod
Sponsored by
Gilead Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis B

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

  • Willing and able to provide informed consent
  • Chronic HBV infection for at least 6 months
  • Willing to follow protocol-specified contraception requirement

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.

Sites / Locations

  • Liverpool Hospital
  • Royal Melbourne Hospital
  • Aalborg University Hospital
  • Aarhus University Hospital
  • Hvidovre Hospital
  • Odense University Hospital
  • Princess Margaret Hospital (Hong Kong)
  • Queen Mary Hospital
  • Prince of Wales Hospital
  • Alice Ho Miu Ling Nethersole Hospital
  • Seoul National University Hospital
  • Asan Medical Center
  • Samsung Medical Center
  • Seoul Saint Mary Hospital
  • Chung-Ang University Hospital
  • Yonsei University Severance Hospital
  • Korea University Guro Hospital
  • Auckland City Hospital
  • National University Hospital
  • Changi General Hospital
  • Singapore General Hospital
  • Thai Red Cross AIDS Research Centre (HIV-NAT)
  • Ramathibodi Hospital
  • Siriraj Hospital
  • Chiang Mai University, Maharaj Nakorn Chiang Mai Hospital
  • King's College Hospital NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Cohort 1: TAF + VIR-2218 + SLGN + Nivolumab

Cohort 2 Group A: VIR-2218 + SLGN + Nivolumab

Cohort 2 Group B: SLGN + Nivolumab

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Proportion of Participants Who Achieve Functional Cure
Functional cure is defined as hepatitis B surface antigen (HBsAg) loss and hepatitis B virus (HBV) DNA < lower limit of quantitation (LLOQ)

Secondary Outcome Measures

Proportion of Participants With Hepatitis B Surface Antigen (HBsAg) Loss With and Without Anti-HBsAg Seroconversion
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
Proportion of Participants Who Remain Off Nucleos(t)ide(s) (NUC) Treatment During Follow-Up
Proportion of Participants Experiencing Hepatitis B Virus (HBV) Virologic Breakthrough
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.

Full Information

First Posted
May 14, 2021
Last Updated
June 2, 2023
Sponsor
Gilead Sciences
Collaborators
Vir Biotechnology, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT04891770
Brief Title
Study to Evaluate the Safety and Efficacy of Selgantolimod (SLGN)-Containing Combination Therapies for the Treatment of Chronic Hepatitis B (CHB)
Official 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)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 14, 2021 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences
Collaborators
Vir Biotechnology, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis B

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
103 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1: TAF + VIR-2218 + SLGN + Nivolumab
Arm Type
Experimental
Arm Description
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.
Arm Title
Cohort 2 Group A: VIR-2218 + SLGN + Nivolumab
Arm Type
Experimental
Arm Description
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.
Arm Title
Cohort 2 Group B: SLGN + Nivolumab
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Tenofovir Alafenamide
Other Intervention Name(s)
TAF, Vemlidy®, GS-7340
Intervention Description
Administered as film-coated oral tablets
Intervention Type
Drug
Intervention Name(s)
VIR-2218
Intervention Description
Administered as a sub-cutaneous (SC) injection
Intervention Type
Drug
Intervention Name(s)
Nivolumab
Other Intervention Name(s)
Opdivo®
Intervention Description
Administered intravenously
Intervention Type
Drug
Intervention Name(s)
Selgantolimod
Other Intervention Name(s)
SLGN, GS-9688
Intervention Description
Administered as film-coated oral tablets
Primary Outcome Measure Information:
Title
Proportion of Participants Who Achieve Functional Cure
Description
Functional cure is defined as hepatitis B surface antigen (HBsAg) loss and hepatitis B virus (HBV) DNA < lower limit of quantitation (LLOQ)
Time Frame
Up to Week 60
Secondary Outcome Measure Information:
Title
Proportion of Participants With Hepatitis B Surface Antigen (HBsAg) Loss With and Without Anti-HBsAg Seroconversion
Time Frame
Up to 84 Weeks
Title
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
Time Frame
Up to 84 Weeks
Title
Proportion of Participants Who Remain Off Nucleos(t)ide(s) (NUC) Treatment During Follow-Up
Time Frame
Week 36 up to Week 84
Title
Proportion of Participants Experiencing Hepatitis B Virus (HBV) Virologic Breakthrough
Description
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.
Time Frame
Up to 36 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Willing and able to provide informed consent Chronic HBV infection for at least 6 months Willing to follow protocol-specified contraception requirement 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilead Study Director
Organizational Affiliation
Gilead Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Liverpool Hospital
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
Facility Name
Royal Melbourne Hospital
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Aalborg University Hospital
City
Aalborg
ZIP/Postal Code
DK9000
Country
Denmark
Facility Name
Aarhus University Hospital
City
Aarhus N
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Hvidovre Hospital
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
Facility Name
Odense University Hospital
City
Odense
ZIP/Postal Code
DK5000
Country
Denmark
Facility Name
Princess Margaret Hospital (Hong Kong)
City
Hong Kong
Country
Hong Kong
Facility Name
Queen Mary Hospital
City
Hong Kong
Country
Hong Kong
Facility Name
Prince of Wales Hospital
City
Shatin
Country
Hong Kong
Facility Name
Alice Ho Miu Ling Nethersole Hospital
City
Tai Po
Country
Hong Kong
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Seoul Saint Mary Hospital
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
Chung-Ang University Hospital
City
Seoul
ZIP/Postal Code
06973
Country
Korea, Republic of
Facility Name
Yonsei University Severance Hospital
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Korea University Guro Hospital
City
Seoul
ZIP/Postal Code
152-703
Country
Korea, Republic of
Facility Name
Auckland City Hospital
City
Grafton
ZIP/Postal Code
1010
Country
New Zealand
Facility Name
National University Hospital
City
Singapore
ZIP/Postal Code
119228
Country
Singapore
Facility Name
Changi General Hospital
City
Singapore
ZIP/Postal Code
529889
Country
Singapore
Facility Name
Singapore General Hospital
City
Singapore
Country
Singapore
Facility Name
Thai Red Cross AIDS Research Centre (HIV-NAT)
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Facility Name
Ramathibodi Hospital
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Siriraj Hospital
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Chiang Mai University, Maharaj Nakorn Chiang Mai Hospital
City
Muang
ZIP/Postal Code
50200
Country
Thailand
Facility Name
King's College Hospital NHS Foundation Trust
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.gileadclinicaltrials.com/study/?id=GS-US-465-4439
Description
Gilead Clinical Trials Website

Learn more about this trial

Study to Evaluate the Safety and Efficacy of Selgantolimod (SLGN)-Containing Combination Therapies for the Treatment of Chronic Hepatitis B (CHB)

We'll reach out to this number within 24 hrs