A Multicenter Study of AHB-137 Injection Combined With Other Hepatitis B Drugs

Официальное название

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 Pegylated Interferon α-2b (Peg-IFN) in Participants With HBeAg-Negative Chronic Hepatitis B (CHB) Treated With Nucleos(t)Ide Analogue (NAs)

Обзор

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.

Вмешательства

• Препарат AHB-137
  AHB-137 will be injected.
• Препарат Peg-IFN
  Peg-IFN will be administered .
• Препарат Hepatitis B Vaccine
  Hepatitis B vaccine will be administered.

Первичные конечные точки

• Proportion of participants with persistent HBsAg < limit of detection (LOD) and HBV DNA < lower limit of quantification (LLOQ) at the 24th week after all treatment for CHB was discontinued. [Срок оценки: up to 72 weeks]

Вторичные конечные точки (12)

• Proportion of participants with persistent HBsAg < LOD and HBV DNA < LLOQ . [Срок оценки: Up to 72 weeks]
• Detection of the serum concentration of HBsAg, HBsAb, HBV DNA, HBV RNA, HBcrAg, HBeAb,and HBeAg. [Срок оценки: Up to 72 weeks]
• Proportion of participants who met discontinuation criteria for NAs treatment at the end of the treatment period. [Срок оценки: Up to 48 weeks]
• Relapse rate after discontinuation of NAs therapy. [Срок оценки: Up to 72 weeks]
• Change from baseline in alanine aminotransferase (ALT) values and time to normalization of values. [Срок оценки: Up to 72 weeks]
• Relapse time after discontinuation of NAs therapy. [Срок оценки: Up to 72 weeks]
• Plasma concentrations of AHB-137. [Срок оценки: Up to 48 weeks]
• Serum concentrations of Peg-IFN. [Срок оценки: Up to 48 weeks.]
• Safety: Number and percentage of participants with detectable anti-drug antibodies (ADA). [Срок оценки: Up to 72 weeks]
• Safety: Changes of the hepatitis B quality of life (HBQOL) instrument in participants compared with baseline. [Срок оценки: Up to 72 weeks]
• Safety: Number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAE) and clinically significant examination results. [Срок оценки: Up to 72 weeks]
• Safety: Monitoring the score changes of Columbia Suicide Severity Scale (CSSRS) . [Срок оценки: Up to 72 weeks.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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 cytotoxic drugs within 6 months prior to the first dose;Or a history of vaccination within 6 months prior to screening or a live vaccination plan during the trial;
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 14 центров

• Beijing Friendship Hospital, Capital Medical University — Пекин
• AusperBio Investigational Site — Чунцин
• AusperBio Investigational Site — Фучжоу
• AusperBio Investigational Site — Гуанчжоу
• AusperBio Investigational Site — Гуанчжоу
• AusperBio Investigational Site — Шэньчжэнь
• AusperBio Investigational Site — Шэньчжэнь
• AusperBio Investigational Site — Zunyi
• … и ещё 6 центров

Идентификаторы

NCT: NCT07069569 · AB-10-8007

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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