An Open-label Extension Trial of the Long Term Safety of Nintedanib in Patients With Progressive Fibrosing Interstitial Lung Disease (PF-ILD)

CompletadoFase 3ClinicalTrials.gov

ID: NCT03820726Tipo: INTERVENTIONALInicio: 16 de abr de 2019Fin estimado: 30 de ago de 2022

Traducción no disponible, mostrando original

Resumen

The main objective is to assess long term tolerability and safety of treatment with oral nintedanib in patients with Progressive Fibrosing Interstitial Lung Disease (PF-ILD) who have complete (and did not prematurely discontinue trial medication in) the phase III parent trial, INBUILD® (trial 1199.247).

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Male or female patients who completed the INBUILD® trial as planned and who did not prematurely discontinue blinded treatment.
Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
Women of childbearing potential (WOCBP)1 must continue 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, as well as one barrier method, for 28 days prior to and 3 months after nintedanib administration. A list of contraception methods meeting these criteria is provided in the patient information

Criterios de exclusión

Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial
Patient not compliant in parent trial (INBUILD®), with trial medication or trial visits, according to investigator's judgement.

Intervenciones

drug

Nintedanib

Bid

Ubicaciones

Centro Dr. Lazaro Langer S.R.L

Alberdi Sur, Argentina

Centro de Investigaciones Metabólicas (CINME)

C.a.b.a, Argentina

CEMER-Centro Medico De Enfermedades Respiratorias

Florida, Argentina

INSARES

Mendoza, Argentina

Instituto Médico de la Fundación Estudios Clínicos

Rosario, Argentina

Patrocinadores

PrincipalBoehringer Ingelheim

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