Меню
Идёт набор NCT05795140

Evaluate Long-term Safety, Tolerability and Efficacy of Iptacopan in Study Participants With aHUS

Фаза III С лечением Atypical Hemolytic Uremic Syndrome

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Iptcaopan 200 mg.
Кому может быть актуально
Состояния в реестре: Atypical Hemolytic Uremic Syndrome. Базовые параметры: 18 лет — 100 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Бразилия, Китай, Чехия, Индия, Япония +1
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

A Multi-center, Single Arm, Open-label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Iptacopan in Participants With Atypical Hemolytic Uremic Syndrome (aHUS) Who Have Completed a Preceding Iptacopan Phase 3 Study in aHUS

Обзор

This is a multicenter, single arm, open-label, extension study to evaluate the long-term safety, tolerability, and efficacy of iptacopan in participants with aHUS.

Подробное описание

The extension study Baseline/Day 1 visit is equivalent to the End of Treatment visit of the parent study. The study will begin on Day 1 followed by on-site visits every 4 months during the study treatment period. A Safety Follow Up tele-visit must be conducted 7 days after last study treatment to collect information on Adverse Events.

Вмешательства

  • Препарат Iptcaopan 200 mg
    Open label, participant specific kits, hard gelatin capsules to be taken twice a day

Первичные конечные точки

  • Number of participants with adverse events and serious adverse events [Срок оценки: Throughout the study duration, up to 4 years]
Вторичные конечные точки (6)
  • Number of participants with absence of TMA manifestation without the use of anti-C5 antibody [Срок оценки: Throughout the study duration, up to 4 years]
  • Number of participants with complete TMA response status without the use of anti-C5 antibody therapy [Срок оценки: Throughout the study duration, up to 4 years]
  • Estimated glomerular filtration rate (eGFR) [Срок оценки: Throughout study duration, up to 4 years]
  • Chronic kidney disease (CKD) stage [Срок оценки: Throughout study duration, up to 4 years]
  • Number of participants by dialysis requirement status [Срок оценки: Throughout the study duration, up to 4 years]
  • Number of participants with Thrombotic Microangiopathy (TMA) related adverse events [Срок оценки: Throughout study duration, up to 4 years]

Критерии участия

Критерии включения

  • Signed informed consent must be obtained prior to participation in the open label extension study
  • Willing and able to comply with the study Schedule of Activities
  • Participants who have completed the full study treatment period of any prior "Novartis sponsored" iptacopan Phase 3 clinical trial in aHUS (e.g. CLNP023F12301 , CLNP023F12302), are still on iptacopan study treatment and derive benefit from it as per Investigator's judgement
  • Prior vaccinations against Neisseria meningitidis, Streptococcus pneumoniae and Haemophilus influenzae infections should be up to date (i.e., any boosters required should be administered according to local guidelines)

Критерии исключения

  • Concomitant treatment with any complement inhibitor as well as concomitant treatment with any of the prohibited drugs
  • Any comorbidity or medical condition (including but not limited to any active systemic bacterial, viral or fungal infection or malignancy) that, in the opinion of the Investigator could put the participant at risk
  • Active infection or history of recurrent invasive infections caused by encapsulated bacteria such as Neisseria meningitidis, Streptococcus pneumoniae or Haemophilus influenzae
  • History of hypersensitivity to iptacopan or its excipients or to drugs of similar chemical classes
  • Pregnant or nursing (lactating) women
  • Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of investigational drug and for 1 week after stopping of investigational drug.

Other protocol-defined inclusion/exclusion criteria may apply.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Бразилия · 2 центра
  • Novartis Investigative Site — São Paulo
  • Novartis Investigative Site — Rio de Janeiro
Индия · 2 центра
  • Novartis Investigative Site — Nagpur
  • Novartis Investigative Site — Pune
Turkey (Türkiye) · 2 центра
  • Novartis Investigative Site — Ankara
  • Novartis Investigative Site — Mersin
Китай · 1 центр
  • Novartis Investigative Site — Пекин
Чехия · 1 центр
  • Novartis Investigative Site — Ostrava
Япония · 1 центр
  • Novartis Investigative Site — Iruma-gun

Идентификаторы

NCT: NCT05795140 · CLNP023F12001B · 2022-502965-34-00

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗