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STATUS Study Complete

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

LAST UPDATED

October 01 2024

Clinicaltrials.gov ID

NCT04891770

EudraCT ID

2021-000672-11

OVERVIEW

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)

PROTOCOL 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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Participation Requirements

Calendar

Age

18 Years - 65 Years

Condition

Sex

ALL

Healthy Icon

Healthy Volunteers

No

Study Details

Medical Condition

Chronic Hepatitis B

Gender

N/A

Date

August 2021 - January 2024

Study Type

INTERVENTIONAL

Study Phase

PHASE2

Product

Tenofovir Alafenamide, VIR-2218, Nivolumab, Selgantolimod

Eligibility Information

Inclusion

Inclusion Criteria

  • 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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Exclusion

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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Locations

Locations (26)
Other

Liverpool Hospital

Liverpool, New South Wales, Australia, 2170

Other

Royal Melbourne Hospital

Parkville, Victoria, Australia, 3050

Other

Aalborg University Hospital

Aalborg, Denmark, DK9000

Other

Aarhus University Hospital

Aarhus N, Denmark, 8200

Other

Hvidovre Hospital

Hvidovre, Denmark, 2650

Other

Odense University Hospital

Odense, Denmark, DK5000

Other

Princess Margaret Hospital (Hong Kong)

Hong Kong, Hong Kong

Other

Queen Mary Hospital

Hong Kong, Hong Kong

Other

Prince of Wales Hospital

Shatin, Hong Kong

Other

Alice Ho Miu Ling Nethersole Hospital

Tai Po, Hong Kong

Other

Seoul National University Hospital

Seoul, Korea, Republic of, 03080

Other

Asan Medical Center

Seoul, Korea, Republic of, 05505

Other

Samsung Medical Center

Seoul, Korea, Republic of, 06351

Other

Seoul Saint Mary Hospital

Seoul, Korea, Republic of, 06591

Other

Chung-Ang University Hospital

Seoul, Korea, Republic of, 06973

Other

Yonsei University Severance Hospital

Seoul, Korea, Republic of, 120-752

Other

Korea University Guro Hospital

Seoul, Korea, Republic of, 152-703

Other

Auckland City Hospital

Grafton, New Zealand, 1010

Other

National University Hospital

Singapore, Singapore, 119228

Other

Changi General Hospital

Singapore, Singapore, 529889

Other

Singapore General Hospital

Singapore, Singapore

Other

Thai Red Cross AIDS Research Centre (HIV-NAT)

Bangkok, Thailand, 10330

Other

Ramathibodi Hospital

Bangkok, Thailand, 10400

Other

Siriraj Hospital

Bangkok, Thailand, 10700

Other

Chiang Mai University, Maharaj Nakorn Chiang Mai Hospital

Muang, Thailand, 50200

Other

King's College Hospital NHS Foundation Trust

London, United Kingdom, SE5 9RS