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TLR8 Agonist

Selgantolimod for Chronic Hepatitis B and HIV

Phase 2
Recruiting
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at week 4, 12, 24, 36 and 48
Awards & highlights

Summary

This trial will test if the drug Selgantolimod is safe and tolerated when given to people with both hepatitis B and HIV who have been on antiviral therapy for both viruses for at least 5 years. The study will also see if Selgantolimod can reduce the level of hepatitis B surface antigen in the blood.

Who is the study for?
Adults aged 18-70 with chronic Hepatitis B and HIV, on effective antiviral therapy for both for over 5 years, having low HBV DNA levels and high HBsAg levels. They must have a stable immune status (CD4+ count ≥350 cells/mm3) and controlled HIV viral load. Excluded are those with recent HCV treatment, liver cancer or organ transplants, certain infections or advanced liver damage.Check my eligibility
What is being tested?
The trial is testing Selgantolimod, an oral drug that targets the immune system's TLR8 receptor. It's given to participants for 24 weeks to see if it can lower hepatitis B surface antigen levels in people who also have HIV but are already on suppressive antiviral therapy.See study design
What are the potential side effects?
While specific side effects of Selgantolimod aren't listed here, drugs like it may cause flu-like symptoms, gastrointestinal issues, skin reactions or changes in blood tests that monitor liver function.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at week 4, 12, 24, 36 and 48
This trial's timeline: 3 weeks for screening, Varies for treatment, and at week 4, 12, 24, 36 and 48 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of participants who experienced adverse events (AEs)
Therapeutic procedure
Proportion of participants with ≥1 log10 IU/mL decline from baseline in quantitative HBsAg (qHBsAg) after SLGN treatment at Week 24
Secondary outcome measures
Changes from baseline in qHBsAg levels at Weeks 4, 12, 24, 36, and 48
Detection of plasma HIV RNA >50 copies/mL at weeks 2, 4, 24, and 48
Hepatitis B Surface Antigens
+7 more

Side effects data

From 2020 Phase 2 trial • 48 Patients • NCT03491553
67%
Nausea
33%
Myalgia
22%
Vomiting
22%
Back pain
22%
Headache
22%
Dyspnoea
22%
Dizziness
22%
Chills
11%
Abdominal distension
11%
Upper respiratory tract infection
11%
Abdominal pain upper
11%
Thirst
11%
Feeling hot
11%
Diarrhoea
11%
Perineal abscess
11%
Skin mass
11%
Menorrhagia
11%
Oropharyngeal pain
11%
Eyelids pruritus
11%
Asthenia
11%
Contusion
11%
Joint stiffness
11%
Nocturia
11%
Lower respiratory tract congestion
11%
Palpitations
11%
Abdominal pain
11%
Hypoaesthesia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo: HBeAg-positive CHB Participants
Selgantolimod 3 mg: HBeAg-positive CHB Participants
Selgantolimod 1.5 mg: HBeAg-negative CHB Participants
Selgantolimod 3 mg: HBeAg-negative CHB Participants
Placebo: HBeAg-negative CHB Participants
Selgantolimod 1.5 mg: HBeAg-positive CHB Participants

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm AExperimental Treatment1 Intervention
Selgantolimod 3 mg once weekly for 24 weeks
Group II: Arm BPlacebo Group1 Intervention
Matching Placebo for Selgantolimod once weekly for 24 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Selgantolimod
2018
Completed Phase 2
~120

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Hepatitis B, such as entecavir and tenofovir, work by inhibiting the viral polymerase enzyme, which is crucial for HBV DNA replication. Entecavir is known for its potent antiviral activity and low resistance rates, while tenofovir is effective even in patients with prior drug resistance. These treatments help reduce viral load, improve liver function, and decrease the risk of liver-related complications. Novel small molecule inhibitors are being explored to target different stages of the HBV life cycle, potentially offering more comprehensive viral suppression. TLR8 agonists like Selgantolimod aim to stimulate the immune system to enhance the clearance of infected cells, representing a promising approach in the ongoing effort to achieve a functional cure for Hepatitis B.
Antihepatitis B therapy: a review of current medications and novel small molecule inhibitors.Antiviral therapy for prevention of hepatocellular carcinoma and mortality in chronic hepatitis B: systematic review and meta-analysis.Replication of clinical hepatitis B virus isolate and its application for selecting antiviral agents for chronic hepatitis B patients.

Find a Location

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,283 Previous Clinical Trials
5,498,884 Total Patients Enrolled
17 Trials studying Hepatitis B
9,783 Patients Enrolled for Hepatitis B

Media Library

Selgantolimod (TLR8 Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT05551273 — Phase 2
Hepatitis B Research Study Groups: Arm B, Arm A
Hepatitis B Clinical Trial 2023: Selgantolimod Highlights & Side Effects. Trial Name: NCT05551273 — Phase 2
Selgantolimod (TLR8 Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05551273 — Phase 2
~12 spots leftby Jan 2025