A Phase III Study to Evaluate the Efficacy and Safety of Libevitug in Participants With Chronic HDV Infection (D-clear Study)

Официальное название

A Multicenter, Randomized, Controlled, Open-label, Phase III Study to Assess Efficacy and Safety of Libevitug Injection in Participants With Chronic Hepatitis Delta Virus Infection (D-clear Study)

Обзор

This is an international, multicenter, randomized, controlled, open-label Phase III trial. It will evaluate the efficacy and safety of libevitug in participants with chronic HDV infection.

Вмешательства

• Препарат Libevitug 20 mg/kg
  Route of administration: intravenous infusion
• Препарат Libevitug 10 mg/kg
  Route of administration: intravenous infusion
• Другое Delayed treatment with libevitug
  Route of administration: intravenous infusion

Первичные конечные точки

• Proportion of participants with HDV RNA below LLOQ with TND or a decrease of ≥ 2 log10 from baseline, and ALT normalization at Week 48 of the treatment period [Срок оценки: Week 48]

Вторичные конечные точки (11)

• Proportion of participants with HDV RNA below LLOQ or a decrease of ≥ 2 log10 from baseline, and ALT normalization [Срок оценки: up to week 96]
• Proportion of participants with HDV RNA below LLOQ or a decrease of ≥ 2 log10 from baseline [Срок оценки: up to week 96]
• Proportion of participants with plasma HDV RNA achieving HDV RNA < LLOQ [Срок оценки: up to week 96]
• Proportion of participants with ALT normalization [Срок оценки: up to week 96]
• Change from baseline in liver stiffness measurement (LSM) [Срок оценки: up to week 96]
• Change from baseline in plasma HDV RNA levels at different time points [Срок оценки: up to week 96]
• Change from baseline in Model for End-Stage Liver Disease (MELD) score at different time points [Срок оценки: up to week 96]
• Change from baseline in Child-Pugh score at different time points during the treatment period, extended treatment period and follow-up period. (A higher Child-Pugh score indicates poorer liver function, more severe disease, and a worse prognosis) [Срок оценки: up to week 96]
• Liver related clinical events [Срок оценки: up to week 120]
• Percentage of participants with treatment-emergent adverse events (TEAEs) [Срок оценки: up to week 120]
• Ctrough,ss [Срок оценки: up to week 96]

Критерии участия

Критерии включения

• Willing to sign written informed consent;
• Chronic HDV history with at least 6 months;
• HDV RNA ≥500 IU/mL at screening;
• ALT >1ULN and <10×ULN;
• Able to communicate well and comply with protocol.

Критерии исключения

• Concomitant decompensated cirrhosis;
• Previous or current HCC or suspicion for HCC;
• Participants with history of alcoholic liver disease, nonalcoholic steatohepatitis or other clinically significant chronic liver diseases not caused by HDV/HBV;
• Participants with active hepatitis C infection, or HIV infection;
• Alcohol abuse or drug addiction within 1 year;
• Participants have participated in other clinical trial within 1 month;
• Pregnant, lactating women.

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

• The First Hospital of Jilin University — Changchun

Идентификаторы

NCT: NCT07499544 · HH003-301

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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