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Набира участници Фаза 3 NCT06238622

A Follow-up Study to Test Long-term Treatment With Nerandomilast in People With Pulmonary Fibrosis Who Took Part in a Previous Study With Nerandomilast

Фаза 3 – широко изпитване преди одобрение
Заболявания: Idiopathic Pulmonary Fibrosis Progressive Pulmonary Fibrosis

Спонсор: Boehringer Ingelheim

Налично на: БГ
Обобщение
This study is open to people with idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF). They can only take part if they have completed treatment in a previous study with a medicine called nerandomilast or BI 1015550. The goal of this study is to find out how well people with pulmonary fibrosis tolerate long- term treatment with nerandomilast. The study also tests whether nerandomilast improves lung function and prolongs the time until symptoms get worse, participants need to go to the hospital, or die. Every participant takes nerandomilast as tablets for up to 1 year and 10 months. The participants may also continue their regular treatment for pulmonary fibrosis during the study. Participants visit their doctors regularly. During these visits, the doctors collect information on any health problems of the participants. Participants also regularly do lung function tests.
Кой може да участва
Inclusion Criteria: 1. Patients who completed treatment in the parent trials (1305-0014, 1305-0023, or 1305-0035) without prematurely discontinuing treatment permanently according to protocol (i.e. completed treatment with or without temporary treatment interruption) 2. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial 3. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. WOCBP taking oral contraceptives (OCs) also have to ensure the use of one barrier method during sexual intercourse with their partner, e.g., condom to account for the risk of potentially reduced efficacy of the OCs in the event of severe vomiting and diarrhoea. For France, fertile males must be ready and able to use acceptable methods of birth control Exclusion Criteria: 1. Any disease that may put the patient at risk when participating in this trial at investigator's discretion. 2. Patient exhibits suicidality, in the clinical judgment of the investigator or according to the following criteria at Visit 1: * any suicidal behaviour (i.e. actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behaviour) * any suicidal ideation of type 4 or 5 in the Columbia-Suicide Severity Rating Scale (C-SSRS) (i.e. active suicidal thought with intent but without specific plan, or active suicidal thought with plan and intent) 3. Patients with clinically relevant severe depression at investigator's discretion or a Hospital Anxiety and Depression Scale (HADS) subscore \>14 at Visit 1. 4. An occurrence of malignant neoplasm other than appropriately treated basal cell carcinoma or in situ squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix at Visit 1. 5. Patient will undergo lung transplantation, with an assigned date of surgery. 6. Patients with a Body Mass index (BMI) \<18.5 kg/m² that experienced an additional, unexplained and clinically significant (\>10%) weight loss during the parent trial 7. At Visit 1, patients with ongoing Adverse Event of Special Interest (AESI), except for latent tuberculosis (suspected vasculitis, Drug Induced Liver Injury (DILI), severe infections) that led to temporary treatment interruption in the parent trial 8. Patients who must or wish to take restricted medications or any drug considered likely to interfere with the safe conduct of the trial. Further exclusion criteria apply.
Места на провеждане 40
Argentina (1)
Centro de Investigaciones Metabolicas (CINME)-C.A.B.A-61553
C.a.b.a
ACTIVE_NOT_RECRUITING
Австралия (1)
Canberra Hospital
Garran , Australian Capital Territory
ACTIVE_NOT_RECRUITING
Белгия (1)
Ziekenhuis Netwerk Antwerpen (ZNA) - Campus Middelheim
Antwerp
ACTIVE_NOT_RECRUITING
Бразилия (1)
Serviços Medicos Respirar Sul Fluminense
Barra Mansa
ACTIVE_NOT_RECRUITING
Канада (1)
University of Alberta Hospital (University of Alberta)
Edmonton , Alberta
Chile (1)
Instituto Nacional del Tórax
Providencia, Santiago de Chile
ACTIVE_NOT_RECRUITING
Китай (1)
Beijing Chao-Yang Hospital
Beijing
COMPLETED
Хърватия (1)
University hospital center Zagreb
Zagreb
ACTIVE_NOT_RECRUITING
Чехия (1)
University Thomayer´s Hospital
Prague
Дания (1)
Gentofte Hospital
Hellerup
Estonia (1)
North Estonia Medical Centre Foundation, Tallinn
Tallinn
ACTIVE_NOT_RECRUITING
Финландия (1)
HYKS Keuhkosairauksien tutkimusyksikkö
Helsinki
ACTIVE_NOT_RECRUITING
Франция (1)
HOP d'Angers
Angers
ACTIVE_NOT_RECRUITING
Georgia (1)
National Center for Tuberculosis and Lung Diseases, Tbilisi
Tbilisi
NOT_YET_RECRUITING
Гърция (1)
Hospital of Heraklion (PAGNI)
Heraklion
ACTIVE_NOT_RECRUITING
Унгария (1)
Koranyi National Institute For Pulmonolgy
Budapest
Индия (1)
Bhatia Hospital
Mumbai
Ireland (1)
Connolly Hospital Blanchardstown
Dublin
ACTIVE_NOT_RECRUITING
Израел (1)
Shamir Medical Center (Assaf Harofeh)
Beer Yaakov
Италия (1)
ASST degli Spedali Civili di Brescia
Brescia
Япония (1)
Tosei General Hospital
Aichi, Seto
Malaysia (1)
Hospital Pulau Pinang-Pulau Pinang-21953
George Town
COMPLETED
Mexico (1)
Centro de Investigacion Integral MEDIVEST S.C
Chihuahua City
ACTIVE_NOT_RECRUITING
Нидерландия (1)
Zuyderland Medisch Centrum
HEERLENHeerlen
ACTIVE_NOT_RECRUITING
New Zealand (1)
Aotearoa Clinical Trials
Papatoetoe , Auckland
ACTIVE_NOT_RECRUITING
Норвегия (1)
Haukeland Universitetssykehus
Bergen
ACTIVE_NOT_RECRUITING
Полша (1)
University Clinical Center, Gdansk
Gdansk
ACTIVE_NOT_RECRUITING
Saudi Arabia (1)
King Abdullah International Medical Research Center
Riyadh
Сърбия (1)
University Clinical Center of Serbia
Belgrade
ACTIVE_NOT_RECRUITING
Сингапур (1)
Singapore General Hospital
Singapore
ACTIVE_NOT_RECRUITING
Словения (1)
Hospital Golnik - Univ. Clinic of Pulmonary and Allergic Diseases
Golnik
COMPLETED
South Africa (1)
Enhancing Care Foundation NPC
Mount Edgecombe
ACTIVE_NOT_RECRUITING
Южна Корея (1)
The Catholic University of Korea, Bucheon St.Mary's Hospital
Bucheon-si
ACTIVE_NOT_RECRUITING
Испания (1)
Hospital General Universitario de Alicante
Alicante
Швеция (1)
Universitetssjukhuset, Linköping
Linköping
COMPLETED
Taiwan (1)
Changhua Christian Hospital
Changhua
Тайланд (1)
Siriraj Hospital
Bangkok Noi
ACTIVE_NOT_RECRUITING
Турция (1)
Gulhane Training and Research Hospital
Ankara
Великобритания (1)
Aberdeen Royal Infirmary
Aberdeen
ACTIVE_NOT_RECRUITING
САЩ (1)
University of Alabama at Birmingham
Birmingham , Alabama
Технически детайли
Статус
Набира участници
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
06.05.2024
Крайна дата
05.05.2027
Регистрационен номер
NCT06238622
Източник
anzctr
Запитване за медицински туризъм

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