What is the mechanism of action of this treatment?

Common treatments for Chronic Hepatitis B, such as nucleos(t)ide analogs like entecavir and tenofovir, work by inhibiting the replication of the hepatitis B virus (HBV) within liver cells. These antiviral agents target the viral polymerase enzyme, which is essential for viral DNA synthesis. By reducing the viral load, these treatments help prevent liver damage, lower the risk of progression to cirrhosis or liver cancer, and improve liver function. This is particularly important for CHB patients as it helps manage the disease and enhances their quality of life.

What side effects are associated with this type of intervention?

Common treatments for Chronic Hepatitis B, such as lamivudine, tenofovir, and entecavir, have well-documented side effects. Lamivudine can lead to the development of drug-resistant HBV strains and, in some cases, liver failure after cessation of treatment. Tenofovir is generally well-tolerated but may cause renal toxicity and decreased bone mineral density with long-term use. Entecavir is also well-tolerated but should not be used in patients with lamivudine-resistant HBV due to a higher risk of resistance. Other side effects across these treatments can include gastrointestinal disturbances, headache, and fatigue.

What prior FDA approvals exist?

The FDA has approved several antiviral agents for the treatment of Chronic Hepatitis B, including entecavir and tenofovir. Entecavir is known for its potent antiviral activity and low resistance rates in nucleos(t)ide-naïve patients, making it a preferred option for long-term therapy. Tenofovir is another first-line treatment, effective in both treatment-naïve patients and those with resistance to other nucleos(t)ide analogs like lamivudine. These drugs work by inhibiting the reverse transcriptase enzyme, thereby reducing viral replication and improving clinical outcomes. Both drugs have shown significant efficacy in viral suppression and histological improvement in chronic hepatitis B patients.

What other types of research exist?

Promising novel alternatives to AHB-137 for CHB patients include next-generation nucleoside and nucleotide analogues, such as tenofovir alafenamide, which has shown efficacy with less renal and bone toxicity compared to tenofovir disoproxil fumarate. Additionally, combination therapies involving pegylated interferon (PegIFN) and nucleos(t)ide analogues have demonstrated improved virologic responses. Specifically, PegIFN combined with lamivudine or other nucleos(t)ide analogues has shown enhanced antiviral benefits. These alternatives are being actively researched and may offer effective treatment options for CHB patients in 2024.

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Antiviral

AHB-137 Injection for Chronic Hepatitis B

Phase 1

Waitlist Available

Led By Ed Gane

Research Sponsored by Ausper Biopharma Co., Ltd.

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 new injection called AHB-137 in healthy people and those with chronic hepatitis B. It aims to see if the medicine is safe, how the body processes it, and its initial effects on the virus.

Who is the study for?

This trial is for adults aged 18-65 with chronic hepatitis B or healthy individuals meeting specific criteria, including a BMI of 19-35 kg/m2 and weight over 45 kg. Participants must test negative for COVID-19 and agree to study requirements. CHB patients should have stable liver function tests and documented HBV infection for at least six months.

What is being tested?

AHB-137, a new drug given by injection, is being tested in this study to assess its safety, how the body processes it (pharmacokinetics), tolerability, and initial effectiveness against chronic hepatitis B virus after single or multiple doses compared to a placebo.

What are the potential side effects?

Potential side effects are not detailed here but typically include reactions at the injection site, general discomforts like headaches or fatigue, possible allergic reactions, and any organ-specific issues that may arise from the medication's action on the virus.

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

Trial Design

4Treatment groups

Experimental Treatment

Group I: Part D: MD in CHB patients in multiple centersExperimental Treatment2 Interventions

Part D: Multiple doses of 200 mg or 300 mg AHB-137 by subcutaneous (SC) injection in CHB patients (Multiple centers across multiple regions).

Group II: Part C: MD in CHB patients (open label)Experimental Treatment1 Intervention

Part C: Multiple doses of 300 mg AHB-137 by subcutaneous (SC) injection in CHB patients.

Group III: Part B: MD in healthy participantsExperimental Treatment2 Interventions

Part B: Multiple doses of 300 mg AHB-137 by subcutaneous (SC) injection in healthy participants.

Group IV: Part A: SAD in healthy participantsExperimental Treatment2 Interventions

Part A: Single ascending doses of up to 450 mg AHB-137 by subcutaneous (SC) injection in healthy participants.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

Do I qualify?Apply below to find out

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

Common treatments for Chronic Hepatitis B, such as nucleos(t)ide analogs like entecavir and tenofovir, work by inhibiting the replication of the hepatitis B virus (HBV) within liver cells. These antiviral agents target the viral polymerase enzyme, which is essential for viral DNA synthesis. By reducing the viral load, these treatments help prevent liver damage, lower the risk of progression to cirrhosis or liver cancer, and improve liver function. This is particularly important for CHB patients as it helps manage the disease and enhances their quality of life.

Hepatitis B virus: promising drug targets and therapeutic implications.