Phase III Study of HRS-5635 in Nucleos(t)Ide Analogue-suppressed HBeAg-negative Patients With Chronic Hepatitis B

Официальное название

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-designed Phase III Clinical Study to Evaluate the Efficacy and Safety of HRS-5635 Injection in Nucleos(t)Ide Analogue-suppressed HBeAg-negative Patients With Chronic Hepatitis B

Обзор

This study is intended to confirm the efficacy, safety, pharmacokinetic (PK) profile, and immunogenicity of HRS-5635 injection as compared to the placebo arm in nucleos(t)ide analogue-suppressed HBeAg-negative patients with chronic hepatitis B. The total duration of the study, including screening (up to 4 weeks), the double-blind treatment stage (60 weeks)，NAs-only treatment stage（12 weeks） and the off-treatment follow-up (24 weeks), is up to approximately 100 weeks at maximum for each participant.

Вмешательства

• Препарат HRS-5635 Injection
  HRS-5635 Injection, administered by subcutaneous injection;
• Препарат Placebo
  Placebo, administered by subcutaneous injection.

Первичные конечные точки

• Percentage of participants with sustained HBV DNA suppression and HBsAg loss within 24 weeks after discontinuation of all HBV therapy [Срок оценки: 24 weeks after discontinuation of all CHB treatment]

Вторичные конечные точки (12)

• Percentage of participants with sustained HBV DNA suppression and HBsAg < 100 IU/mL [Срок оценки: Pre-specified time points up to 24 weeks after discontinuation of all CHB treatment]
• Percentage of participants with sustained HBV DNA suppression and HBsAg < 10 IU/mL [Срок оценки: Pre-specified time points up to 24 weeks after discontinuation of all CHB treatment]
• Percentage of participants with sustained HBV DNA suppression [Срок оценки: Pre-specified time points up to 24 weeks after discontinuation of all CHB treatment]
• Percentage of participants with HBsAg < 100 IU/mL [Срок оценки: Pre-specified time points up to 24 weeks after discontinuation of all CHB treatment]
• Percentage of participants with HBsAg < 10 IU/mL [Срок оценки: Pre-specified time points up to 24 weeks after discontinuation of all CHB treatment]
• Changes from baseline in mean log10 HBsAg levels [Срок оценки: Pre-specified time points up to 24 weeks after discontinuation of all CHB treatment]
• Percentage of participants with HBsAg loss [Срок оценки: Pre-specified time points up to 24 weeks after discontinuation of all CHB treatment]
• Percentage of participants with HBsAg seroconversion [Срок оценки: Pre-specified time points up to 24 weeks after discontinuation of all CHB treatment]
• Percentage of participants with HBeAb positive [Срок оценки: Pre-specified time points up to 24 weeks after discontinuation of all CHB treatment]
• Percentage of participants with virologic breakthrough [Срок оценки: Pre-specified time points up to 24 weeks after discontinuation of all CHB treatment]
• Percentage of participants with drug resistance [Срок оценки: Pre-specified time points up to 24 weeks after discontinuation of all CHB treatment]
• Percentage of participants who meet the criteria for stopping nucleos(t)ide analogue (NA) therapy [Срок оценки: Week 72 and Week 96]

Критерии участия

Критерии включения

• Chronic hepatitis B defined as HBV infection documented for at least 6 months prior to screening;
• Virologically suppressed on nucleoside or nucleotide analogues treatment with HBV DNA below the lower limit of quantitation;
• HBeAg negative at screening;
• On commercially available NAs monotherapy for at least 24 weeks before randomization, and the dosing regimen remained unchanged for at least 4 weeks before randomization;
• Need to take effective contraceptive measures；
• Volunteer to sign an informed consent.

Критерии исключения

• History of cirrhosis or clinical evidence of hepatic decompensation, confirmed or suspected liver cancer, with other liver diseases other than chronic hepatitis B that may affect the evaluation of the study;
• With autoimmune disease;
• History of solid organ transplantation or hematopoietic stem cell transplantation;
• Clinically significant and unstable or uncontrolled severe cardiovascular and cerebrovascular diseases;
• Malignant tumors were diagnosed within 5 years prior to randomization；
• Major trauma or major surgery within the 12 weeks prior to randomization, or surgical plans or other treatment during the study period which the investigators determined may influence the evaluation of the study results;
• Laboratory tests during the screening period were obviously abnormal;
• Prolonged ECG QTcF or other clinically significant abnormal results that may pose a significant safety risk to the subject during the screening period;
• History of drug use, alcohol or drug abuse in the 12 months prior to randomization;
• Participated in clinical study of other drugs (received experimental drugs);
• Pregnant or nursing women;
• Allergic to a drug ingredient or component;
• Other reasons for ineligibility as judged by the investigators.

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

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Nanfang Hospital, Southern Medical University — Гуанчжоу

Идентификаторы

NCT: NCT07606950 · HRS-5635-301

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗