A Multicenter, Randomized, Open, Parallel-designed Study to Evaluate the Efficacy and Safety of HRS-5635 Injection Alone or in Combination With Other Agents in Patients Treated for Chronic Hepatitis B

Официальное название

A Multicenter, Randomized, Open, Parallel-designed Phase II Study to Evaluate the Efficacy and Safety of HRS-5635 Injection Alone or in Combination With Other Agents in Patients Treated for Chronic Hepatitis B

Обзор

A multicenter, randomized, open, parallel-designed Phase II study to evaluate the efficacy and safety of HRS-5635 injection alone or in combination with other agents in patients treated for chronic hepatitis B.

Вмешательства

• Препарат HRS-5635 Injection
  HRS-5635 Injection low dose administered by subcutaneous injection
• Препарат HRS-5635 Injection
  HRS-5635 Injection medium dose administered by subcutaneous injection
• Препарат HRS-5635 Injection
  HRS-5635 Injection high dose administered by subcutaneous injection
• Препарат HRS-5635 Injection
  HRS-5635 Injection lowest dose administered by subcutaneous injection
• Препарат HRS-5635 Injection (low dose) and Peg-IFN-α
  HRS-5635 Injection (low dose) and Peg-IFN-α, administered by subcutaneous injection
• Препарат HRS-5635 Injection (high dose) and Peg-IFN-α
  HRS-5635 Injection (high dose) and Peg-IFN-α, administered by subcutaneous injection
• Препарат Peg-IFN-α
  Peg-IFN-α, administered by subcutaneous injection
• Препарат HRS-5635 Injection with Peg-IFN-α
  HRS-5635 Injection and Peg-IFN-α, administered by subcutaneous injection
• Препарат HRS-5635 Injection
  HRS-5635 Injection, administered by subcutaneous injection

Первичные конечные точки

• PartA：Change in mean log10 serum hepatitis B surface antigen levels from baseline at week 12 [Срок оценки: Week 12]
• PartB：Proportion of subjects whose serum hepatitis B surface antigen (HBsAg) had turned negative at week 48 [Срок оценки: Week 48]
• PartC：Proportion of subjects whose serum hepatitis B surface antigen (HBsAg) had turned negative at week 48 [Срок оценки: Week 48]
• PartD：Proportion of subjects whose serum hepatitis B surface antigen (HBsAg) had turned negative at week 48 [Срок оценки: Week 48]

Вторичные конечные точки (10)

• Changes from baseline in mean log10 serum hepatitis B surface antigen levels [Срок оценки: Pre-specified time points up to 72 weeks]
• Proportion of subjects with at least one log10 decline from baseline in serum hepatitis B surface antigen [Срок оценки: Pre-specified time points up to 72 weeks]
• Proportion of subjects with serum hepatitis B surface antigen loss [Срок оценки: Pre-specified time points up to 72 weeks]
• Proportion of subjects with serum hepatitis B surface antigen seroconversion [Срок оценки: Pre-specified time points up to 72 weeks]
• Proportion of subjects with hepatitis B e-antigen loss [Срок оценки: Pre-specified time points up to 72 weeks]
• Proportion of subjects with serum hepatitis B e-antigen seroconversion [Срок оценки: Pre-specified time points up to 72 weeks]
• Proportion of subjects with virologic breakthrough [Срок оценки: Pre-specified time points up to 72 weeks]
• Proportion of subjects with drug resistance [Срок оценки: Pre-specified time points up to 72 weeks]
• Proportion of subjects who meet the criteria for stopping NA therapy [Срок оценки: From 48 weeks to 72 weeks]
• Proportion of subjects with serum hepatitis B surface antigen loss and HBV DNA loss [Срок оценки: Week 48]

Критерии участия

Критерии включения

• Meet the body mass index standard greater than or equal to 18.5 kg/m2 and less than 35 kg/m2;
• 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;
• 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；
• Infection requiring intervention within 2 weeks 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

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Nanfang Hospital — Гуанчжоу

Идентификаторы

NCT: NCT06425341 · HRS-5635-201

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗