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New treatment option for Chronic Hepatitis B
Official title A Multicenter Study of AHB-137 Injection Combined With Other Hepatitis B Drugs
ClinicalTrials.gov ID: NCT07069569
What this study is testing
What is AHB-137?
AHB-137 is an investigational medicine, given as an injectable medicine, being studied as a potential treatment 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
- This is a randomized, open-label, multicenter phase II study to evaluate the efficacy and safety of AHB-137 injection in combination with other hepatitis B drugs in participants with HBeAg-negative CHB treated with NAs.
- 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
- Participants voluntarily participate in the study, and sign the Informed Consent Form (ICF) prior to screening, able to complete the study according...
- Aged between 18 and 65 years at the time of signing the ICF;
- Body mass index (BMI) within the range of 18-30 kg/ m2;
- HBeAg negative at screening;
- HBsAg or HBV DNA positive for at least 6 months;
You likely can't join if
- Participants who are not eligible for treatment with Peg-IFN/recombinant hepatitis B vaccine;
- Clinically significant abnormalities other than a history of chronic HBV infection;
- Concomitant clinically significant other liver diseases;
- Any serious infection other than chronic hepatitis B infection requiring intravenous anti-infective therapy within 1 month prior to screening;
- HCV RNA positive, Human immunodeficiency virus (HIV) positive, syphilis positive;
- Significant liver fibrosis or cirrhosis at screening, or a liver stiffness value (LSM) \> 9.0 kPa;
See the full eligibility criteria
- Participants voluntarily participate in the study, and sign the Informed Consent Form (ICF) prior to screening, able to complete the study according to the protocol;
- Aged between 18 and 65 years at the time of signing the ICF;
- Body mass index (BMI) within the range of 18-30 kg/ m2;
- HBeAg negative at screening;
- HBsAg or HBV DNA positive for at least 6 months;
- Continue antiviral therapy with a single nucleoside (t) ide analogue for more than 6 months prior to screening;
- Alanine aminotransferase (ALT) ≤ 2 × upper limit of normal (ULN);
- Effective contraception as required.
- Participants who are not eligible for treatment with Peg-IFN/recombinant hepatitis B vaccine;
- Clinically significant abnormalities other than a history of chronic HBV infection;
- Concomitant clinically significant other liver diseases;
- Any serious infection other than chronic hepatitis B infection requiring intravenous anti-infective therapy within 1 month prior to screening;
- HCV RNA positive, Human immunodeficiency virus (HIV) positive, syphilis positive;
- Significant liver fibrosis or cirrhosis at screening, or a liver stiffness value (LSM) \> 9.0 kPa;
- Previous/current manifestations of hepatic decompensation;
- Diagnosis or suspicion of hepatocellular carcinoma, or alpha-fetoprotein concentration (AFP) ≥ 20 ng/mL at screening;
- Obviously abnormal laboratory test results;
- History of vasculitis or presence of signs, symptoms, or laboratory tests of underlying vasculitis, and previous/current other diseases that may be related to vasculitic conditions;
- QT interval corrected for heart rate (Fridericia method) abnormal;
- History of extrahepatic disease possibly related to HBV immune status;
- Participants with a history of malignancy within the past 5 years or who are being evaluated for a possible malignancy;
- Serious mental illness or history of serious mental illness prior to screening;
- Suspected history of allergy to any component of the study drug, or allergic constitution;
- Major trauma or major surgery within 3 months prior to screening, or planned surgery during the study;
- Those who are participating in another clinical trial, or have not undergone a protocol-specified washout period prior to this study;
- Current use or use of any immunosuppressive medication within 3 months prior to screening, with the exception of short courses (≤ 2 weeks) or use of topical/inhaled steroids;Those who have used immunomodulators and...
- Participants requiring regular long-term administration of anticoagulants or antiplatelet drugs;
- Thyroid dysfunction;
- Patients with uncontrolled epilepsy and other progressive neurological disorders;
- Received any antisense oligonucleotides (ASO) or small molecule interfering ribonucleic acid (siRNA) drug;
- Any other circumstance or condition that, in the opinion of the investigator, the participants are inappropriate for participation in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 - 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?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.