Efficacy, Safety, and Pharmacokinetics of LP-005 Injection in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)

Официальное название

A Phase Ⅱ Extension Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of LP-005 Injection in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)

Обзор

This is an extension study for patients who have completed a prior P10-LP005-02 clinical study. The aim of this study is to evaluate the long-term safety, efficacy, and pharmacokinetics of LP-005 injection in adult patients with paroxysmal nocturnal hemoglobinuria (PNH).

Вмешательства

• Биопрепарат LP-005 Injection
  IV infusion, Q4W

Первичные конечные точки

• Incidence of adverse events (AEs) [Срок оценки: Up to approximately 2 years]

Вторичные конечные точки (7)

• Change from baseline in serum lactate dehydrogenase (LDH) levels. [Срок оценки: Up to approximately 2 years]
• Change from baseline in hemoglobin levels. [Срок оценки: Up to approximately 2 years]
• Proportion of patients who are transfusion-free. [Срок оценки: Up to approximately 2 years]
• Proportion of patients achieving hemoglobin levels ≥120 g/L [Срок оценки: Up to approximately 2 years]
• Proportion of patients with breakthrough hemolysis [Срок оценки: Up to approximately 2 years]
• Serum concentrations of LP-005. [Срок оценки: Up to approximately 2 years]
• Number of patients with anti-drug antibodies (ADA) [Срок оценки: Up to approximately 2 years]

Критерии участия

Критерии включения

• Patients have fully understood the trial, have voluntarily agreed to participate in this clinical trial, and have signed a written Informed Consent Form (ICF).
• Patients who have completed the treatment of the Phase Ⅱ clinical study of LP-005 Injection and are assessed by the investigator as eligible for continued treatment with LP-005 Injection.
• Patients who have received Neisseria meningitidis vaccine and Streptococcus pneumoniae vaccine in accordance with the requirements of previous studies; if the vaccine protection period does not cover the treatment duration of this study, patients must agree to receive booster vaccination in a timely manner in accordance with the vaccine administration guidelines and the requirements of local vaccination institutions.
• Females and males of childbearing potential (including male subjects with female partners) must agree to use effective contraceptive measures from the start of the trial until 3 months after the end of the trial.

Критерии исключения

• Patients who have not completed the treatment of the Phase II clinical trial (P10-LP005-02) of the study drug.
• Patients who have completed the Phase II treatment phase but are unwilling to continue receiving the study drug treatment.
• Patients for whom the investigator does not recommend the continued use of LP-005 Injection after comprehensive assessment.
• Patients who did not participate in the Phase II clinical trial (P10-LP005-02) of the study drug.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The First Affiliated Hospital of Nanjing Medical University — Нанкин

Идентификаторы

NCT: NCT07266155 · P10-LP005-05

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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