What side effects are associated with this type of intervention?

The most common treatments for Hepatitis B, including tenofovir, entecavir, and pegylated interferon, have various side effects. Tenofovir is generally well-tolerated but can cause kidney dysfunction and bone mineral density loss. Entecavir has a low rate of drug resistance but may cause headaches, fatigue, dizziness, and in rare cases, lactic acidosis. Pegylated interferon can lead to flu-like symptoms, depression, and cytopenias. While specific side effects of TLR8 agonists like Selgantolimod are still under investigation, they are being studied for their potential to reduce hepatitis B surface antigen (HBsAg) levels in patients co-infected with HIV and HBV.

What prior FDA approvals exist?

FDA-approved treatments for Hepatitis B primarily include antiviral agents such as nucleos(t)ide analogs, which inhibit viral replication. Commonly used drugs include tenofovir, entecavir, and lamivudine. These treatments aim to reduce viral load and prevent liver damage. While the TLR8 agonist Selgantolimod is being studied for its potential to reduce hepatitis B surface antigen (HBsAg) levels, similar immunomodulatory approaches have not yet been widely approved for Hepatitis B. Current research is exploring the efficacy and safety of such novel therapies.

What other types of research exist?

Promising novel alternatives to Selgantolimod for Hepatitis B patients include: 1) Pegylated interferon alfa-2a, which has shown higher rates of HBeAg seroconversion and sustained suppression of HBV DNA levels. 2) CPG 10101 (ACTILON), a TLR9 agonist, which has demonstrated safety and immune effects in early-phase studies. 3) Tetrahydropyridopyrimidine-based TLR 7/8 dual agonists, which have shown potential in antiviral treatment and as vaccine adjuvants.

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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 up to 5 years

Summary

This trial tests a pill called Selgantolimod in patients with chronic hepatitis B and HIV who have been on antiviral therapy for an extended period. The pill aims to activate the immune system to reduce the hepatitis B virus levels in their 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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2020 Phase 2 trial • 48 Patients • NCT03491553

67%

Nausea

33%

Myalgia

22%

Vomiting

22%

Back pain

22%

Dizziness

22%

Headache

22%

Dyspnoea

22%

Chills

11%

Upper respiratory tract infection

11%

Skin mass

11%

Lower respiratory tract congestion

11%

Palpitations

11%

Asthenia

11%

Eyelids pruritus

11%

Abdominal distension

11%

Abdominal pain upper

11%

Diarrhoea

11%

Feeling hot

11%

Thirst

11%

Perineal abscess

11%

Contusion

11%

Joint stiffness

11%

Nocturia

11%

Menorrhagia

11%

Oropharyngeal pain

11%

Abdominal pain

11%

Hypoaesthesia

100%

80%

60%

40%

20%

Study treatment Arm

Placebo: HBeAg-negative CHB Participants

Selgantolimod 3 mg: HBeAg-positive CHB Participants

Selgantolimod 1.5 mg: HBeAg-negative CHB Participants

Placebo: HBeAg-positive CHB Participants

Selgantolimod 3 mg: 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

~220

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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

3,314 Previous Clinical Trials

5,547,659 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

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