Език: EN EN
← Назад към резултатите
Активно (без набиране) Фаза 3 NCT04042402

Long Term Extension Study in Patients With Primary Hyperoxaluria

Фаза 3 – широко изпитване преди одобрение
Заболявания: Primary Hyperoxaluria Type 1 (PH1) Primary Hyperoxaluria Type 2 (PH2) Kidney Diseases Urologic Diseases Genetic Disease Primary Hyperoxaluria Type 3 (PH3)

Спонсор: Dicerna Pharmaceuticals, Inc., a Novo Nordisk company

Налично на: БГ
Обобщение
The proposed study is designed to provide patients previously enrolled in Phase 1 and 2 studies of DCR-PHXC and their siblings (\<18 years old) long-term access to DCR-PHXC, and to evaluate the long-term safety and efficacy of DCR-PHXC in patients with PH.
Кой може да участва
Key Inclusion Criteria: •Participant successfully completed a Dicerna Pharmaceuticals, Inc. study of DCR PHXC. OR Participant is the sibling of a participant who successfully completed a Dicerna Pharmaceuticals, Inc. study of DCR PHXC. Siblings must be younger than 18 years of age and must have genetically confirmed PH. * For participants rolling over from a multidose study of DCR-PHXC, enrollment should occur within a window of 25 to 75 days from the last dose of study intervention. * Estimated GFR at screening ≥ 30 mL/min normalized to 1.73 m2 body surface area (BSA), calculated using Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) formula in participants aged ≥ 18 years, or the multivariate equation by Schwartz in participants aged 12 months to 17 years. In Japan, the cystatin C-based Uemura formula will be used for participants aged 12 months to \<2 years, the creatinine-based Uemura formula by will be used for participants aged 2 to 17 years, and the equation by Matsuo will be used in participants aged ≥ 18 years. Key Exclusion Criteria: * Renal or hepatic transplantation (prior or planned within the study period) * Plasma oxalate \> 30 µmol/L * Currently on dialysis * Documented evidence of clinical manifestations of systemic oxalosis
Места на провеждане 13
Австралия (1)
Clinical Research Site
Herston , Queensland
Канада (1)
Clinical Research Site
Hamilton , Ontario
Франция (1)
Clinical Trial Site
Bron
Германия (1)
Clinical Trial Site
Bonn
Италия (1)
Clinical Research Site
Roma
Япония (1)
Clinical Trial Site
Fukuoka
Lebanon (1)
Clinical Trial Site
Beirut
Нидерландия (1)
Clinical Trial Site
Amsterdam
Норвегия (1)
Clinical Trial Site
Tromsø
Испания (1)
Clinical Research Site
Barcelona
Турция (1)
Clinical Trial Site
Ankara
Великобритания (1)
Clinical Trial Site
Hampstead , London
САЩ (1)
Clinical Research Site
San Francisco , California
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Здрави доброволци
Не
Начална дата
09.07.2019
Крайна дата
01.04.2030
Регистрационен номер
NCT04042402
Източник
anzctr
Запитване за медицински туризъм

Информацията е извлечена автоматично от ClinicalTrials.gov. Консултирайте се с вашия лекар преди да предприемете действия.