Hepatitis B, Chronic study: AHB-137
Official title Study of AHB-137 in Chronic Hepatitis B (CHB) Participants in North America and Europe Regions
ClinicalTrials.gov ID: NCT07654283
What this study is testing
What is AHB-137?
An investigational once‑daily subcutaneous injection being studied for chronic hepatitis B.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see if AHB‑137 helps control hepatitis B and if it is safe for patients who are taking nucleoside analogue drugs.
- Who it's for
- Adults with chronic hepatitis B who are currently receiving nucleoside analogue therapy.
- What's involved
- Participants will receive AHB‑137 injections and will have regular clinic visits and blood tests to monitor their health and the drug’s effects.
- Time commitment
- The trial lasts several months, with multiple scheduled visits for injections and monitoring.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Adults ≥18 years of age and up to 65 years of age (inclusive) at Screening who are able to provide informed consent, comply with study procedures...
- Body mass index (BMI) ≤35 kg/m².
- Documented chronic hepatitis B virus (HBV) infection for ≥6 months prior to randomization, defined by hepatitis B surface antigen (HBsAg) positivity...
- Receiving stable, approved nucleos(t)ide analog (NA) monotherapy for ≥6 months prior to randomization.
- HBV DNA meeting protocol-specified virologic criteria at Screening.
You likely can't join if
- Clinically significant disease other than chronic hepatitis B virus (HBV) infection.
- Concomitant clinically significant liver disease.
- Any severe infection (other than chronic HBV infection) within 1 month prior to randomization.
- History of immune thrombocytopenia.
- Current suspected liver cirrhosis and/or evidence of cirrhosis by protocol-specified criteria for FibroScan® or equivalent imaging modality (e.g...
- History of liver cirrhosis defined by liver biopsy or by FibroScan® or equivalent imaging modality using protocol-specified criteria.
See the full eligibility criteria
Who can join
- Adults ≥18 years of age and up to 65 years of age (inclusive) at Screening who are able to provide informed consent, comply with study procedures, and agree to discontinue nucleos(t)ide analog (NA) therapy if...
- Body mass index (BMI) ≤35 kg/m².
- Documented chronic hepatitis B virus (HBV) infection for ≥6 months prior to randomization, defined by hepatitis B surface antigen (HBsAg) positivity or detectable HBV DNA.
- Receiving stable, approved nucleos(t)ide analog (NA) monotherapy for ≥6 months prior to randomization.
- HBV DNA meeting protocol-specified virologic criteria at Screening.
- Hepatitis B surface antigen (HBsAg) level meeting protocol-specified virologic criteria at Screening.
- Alanine aminotransferase (ALT) meeting protocol-specified criteria at Screening.
- Screening electrocardiogram (ECG) without clinically significant abnormalities and with a Fridericia-corrected QT interval (QTcF) ≤450 msec for males or ≤470 msec for females.
- Females of childbearing potential must not be breastfeeding and must have a negative serum pregnancy test at Screening and a negative urine pregnancy test prior to first dose.
- Males and female participants of childbearing potential must agree to use protocol-specified effective contraception during the dosing period and for ≥6 months after the last dose of AHB-137.
What rules you out
- Clinically significant disease other than chronic hepatitis B virus (HBV) infection.
- Concomitant clinically significant liver disease.
- Any severe infection (other than chronic HBV infection) within 1 month prior to randomization.
- History of immune thrombocytopenia.
- Current suspected liver cirrhosis and/or evidence of cirrhosis by protocol-specified criteria for FibroScan® or equivalent imaging modality (e.g., ultrasound elastography)
- History of liver cirrhosis defined by liver biopsy or by FibroScan® or equivalent imaging modality using protocol-specified criteria.
- Prior history of, current diagnosis of, or suspected hepatocellular carcinoma (HCC), or alpha-fetoprotein (AFP) ≥20 ng/mL at Screening.
- History of extrahepatic diseases potentially associated with HBV infection.
- Laboratory evidence of active infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis D virus (HDV), or active syphilis.
- Protocol-specified abnormal laboratory values at Screening.
- History of vasculitis or presence of signs or symptoms suggestive of vasculitis, or history or presence of diseases associated with vasculitis.
- History of malignancy within 5 years prior to Screening, except for adequately treated non-melanoma skin cancer. Participants currently undergoing evaluation for potential malignancy are excluded.
- History of hypersensitivity or allergy to any component of the investigational product (IP).
- Major trauma or major surgery within 3 months prior to Screening, or planned surgery during the study period unless eligibility is confirmed by the Medical Monitor.
- Current alcohol or substance abuse judged by the Investigator to potentially interfere with participant compliance.
- Female participants who are pregnant, breastfeeding, planning pregnancy during the study, or unwilling to refrain from egg donation and/or in vitro fertilization during the study.
- Five half-lives (if known) or twice the duration of biological effect (if known), whichever is longer, or
- Six months, if neither half-life nor duration of effect is known
- Prior treatment with antisense oligonucleotides (ASOs) or small interfering RNA (siRNA)-based therapies.
- Prolonged use of immunomodulators (e.g., corticosteroids, methotrexate), cytotoxic drugs, or biologics (e.g., monoclonal antibodies) within 6 months prior to first IP administration, except for short-term treatment (≤2...
- Interferon therapy within 12 months prior to first dose
- Vaccination within 1 month prior to Screening, except for influenza or SARS-CoV-2 (COVID-19) vaccination or booster
- Current treatment with bulevirtide
- Requirement for long-term regular use of anticoagulants (e.g., warfarin, factor Xa inhibitors) or antiplatelet agents (e.g., clopidogrel or regular aspirin), except for low-dose aspirin.
- Any other condition or circumstance that, in the Investigator's judgment, would make the participant unsuitable for participation in the study.
The study team makes the final eligibility decision.
Where it is enrolling
- San Antonio, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at San Antonio, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.