70 Participants NeededMy employer runs this trial

AHB-137 for Chronic Hepatitis B

(ASPIRE-202 Trial)

Recruiting at 9 trial locations
MD
Overseen ByMaggie Davis
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: AusperBio Therapeutics Inc.
Must be taking: Nucleos(t)ide analogs
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called AHB-137 for individuals with chronic hepatitis B, a liver infection caused by the hepatitis B virus. The researchers aim to evaluate the treatment's effectiveness and safety for those who have been on the same hepatitis B medication for at least six months. Participants may receive one of two dosing plans, regimen A or B. This trial may suit individuals who have managed hepatitis B with medication for over six months. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Do I have to stop taking my current medications for the trial?

You may need to stop taking your current nucleos(t)ide analog (NA) therapy if certain criteria are met during the trial. The protocol does not specify about other medications, so it's best to discuss your specific situation with the trial team.

Is there any evidence suggesting that AHB-137 is likely to be safe for humans?

Research has shown that AHB-137 is safe, based on previous studies. Patients tolerated the treatment well, with no serious side effects linked to the drug. One study noted that AHB-137 was well-received during both the treatment and follow-up periods, with no major problems reported. Additionally, the treatment was safe and behaved predictably in the body. These findings support its continued development for treating chronic hepatitis B.12345

Why do researchers think this study treatment might be promising for chronic hepatitis B?

Unlike the standard treatments for chronic hepatitis B, which often involve antiviral medications like tenofovir or entecavir that aim to suppress the virus, AHB-137 is a novel therapeutic that may offer something different. Researchers are excited about AHB-137 because it targets the virus with a potentially new mechanism of action, possibly offering improved efficacy or reduced side effects. This treatment is being explored in two different dosing regimens, providing insights into its optimal use. The hope is that AHB-137 could offer a more effective or tolerable option for patients battling this chronic condition.

What evidence suggests that AHB-137 might be an effective treatment for Chronic Hepatitis B?

Research has shown that AHB-137 may help treat chronic hepatitis B (CHB). One study found that after 24 weeks of treatment with AHB-137, 30% of patients achieved a "functional cure," meaning the virus was no longer detectable. Another study reported that after 16 weeks, all patients had very low levels of the virus. AHB-137 also effectively reduces viral DNA and surface antigens, which indicate infection. In this trial, participants will receive AHB-137 according to different dosing regimens in separate arms. These findings suggest AHB-137 could be a promising new option for managing CHB.45678

Who Is on the Research Team?

AL

Audrey Lau, MD, PhD

Principal Investigator

AusperBio Therapeutics Inc.

Are You a Good Fit for This Trial?

This trial is for adults aged 18-65 with chronic hepatitis B who have been on stable antiviral medication for at least 6 months. Participants must have certain lab results, no serious heart or liver problems, and cannot be pregnant or breastfeeding. People with other major infections, cancers, severe diseases, or substance abuse issues are excluded.

Inclusion Criteria

Body mass index (BMI) ≤35 kg/m²
Alanine aminotransferase (ALT) meeting protocol-specified criteria at Screening
I have been on stable, approved NA monotherapy for at least 6 months.
See 7 more

Exclusion Criteria

Participation in another clinical trial or receipt of investigational product within five half-lives or twice biological effect duration or within 6 months if unknown
Laboratory evidence of active infection with HIV, HCV, HDV, or active syphilis (except participants with positive HCV or HDV serology but documented negative RNA)
Protocol-specified abnormal laboratory values at Screening
See 18 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive AHB-137 according to dosing regimens A or B

72 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • AHB-137

Trial Overview

The study tests AHB-137 injections in people with chronic hepatitis B already taking standard antiviral drugs. It is a phase 2 trial where participants are randomly assigned to groups and the study takes place at multiple centers across North America and Europe.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Arm B: Dose Regimen BExperimental Treatment1 Intervention
Group II: Arm A: Dose Regimen AExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

AusperBio Therapeutics Inc.

Lead Sponsor

Trials
1
Recruited
60+

Citations

AHB-137 Demonstrates High Cure Rates, Sustained Viral ...

Weekly AHB-137 300 mg for 16 weeks achieved HBV DNA <10 IU/mL in 100% and complete response in 68% at end of treatment without concomitant ...

NCT07069569 | A Multicenter Study of AHB-137 Injection ...

A Randomized, Open-Label, Multicenter Phase II Study to Evaluate the Efficacy and Safety of AHB-137 Injection in Combination With Hepatitis B Vaccine or ...

AusperBio Announces AHB-137 Monotherapy Achieved 30 ...

The data demonstrated that finite-duration 24-week AHB-137 monotherapy achieved a 30% functional cure rate at Week 72 (EOF) in patients with ...

AHB-137 / AusperBio

AHB-137 monotherapy demonstrated potent inhibition of HBV DNA replication and profound reduction of HBsAg, resulting in a high FC rate.

Small nucleic acid drugs-the dawn of functional cure of ... - PMC

The outcomes indicated that following a 4-week treatment course of AHB-137, 12% (5 out of 40) of CHB patients achieved sustained undetectable HBsAg levels

NCT07370207 | Phase 2 Study of AHB-137 in HBeAg ...

Also called a data safety and monitoring board, or DSMB. Phase 2 Study of AHB-137 in HBeAg Negative Chronic Hepatitis B (CHB) Documented chronic hepatitis B ...

AusperBio Reports 30% Functional Cure Rate With AHB ...

Favorable Safety and Tolerability AHB-137 was well tolerated, throughout treatment and follow-up, with no drug-related serious adverse events ...

Safety, pharmacokinetics and antiviral activity of AHB‑137 in ...

AHB-137 induced rapid, dose-dependent HBsAg reductions after a short 4-week dosing period. Two CHB patients achieved HBsAg loss during follow up ...