Ensayo de extensión abierto de la seguridad a largo plazo de nintedanib en pacientes con enfermedad pulmonar intersticial asociada a esclerosis sistémica (EPI-ES)

CompletadoFase 3ClinicalTrials.gov

ID: NCT03313180Tipo: INTERVENTIONALInicio: 27 de nov de 2017Fin estimado: 25 de ene de 2023

Resumen

El objetivo principal es evaluar la seguridad a largo plazo del tratamiento con nintedanib oral en pacientes con enfermedad pulmonar intersticial asociada a esclerosis sistémica (EPI-ES).

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Patients who completed the parent trial 1199.214/1199-0340 per protocol and did not permanently discontinue study treatment
Signed and dated written informed consent in accordance with International Conference on Harmonisation - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
Women of childbearing potential 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 as well as one barrier method for 28 days prior to nintedanib treatment initiation, during the trial and for 3 months after last intake of nintedanib.

Criterios de exclusión

Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) \> 3 x Upper Limit of Normal (ULN)
Bilirubin \> 2 x ULN
Creatinine clearance \<30 mL/min calculated by Cockcroft-Gault formula.
Clinically relevant anaemia at investigators discretion.
Bleeding risk, any of the following
Known genetic predisposition to bleeding according to the judgement of the investigator
Patients who require
Fibrinolysis, full-dose therapeutic anticoagulation
High dose antiplatelet therapy.
Hemorrhagic central nervous system (CNS) event after completion of the parent trial 1199.214/1199-0340
Any of the following after last treatment of 1199.214/1199-0340:
Haemoptysis or haematuria
Active gastro-intestinal bleeding or Gastrointestinal (GI) - ulcers
Gastric antral vascular ectasia (GAVE)
Major injury or surgery
Coagulation parameters: International normalised ratio (INR) \>2, prolongation of prothrombin time (PT) and partial thromboplastin time (PTT) by \>1.5 x ULN at Visit 1.
New major thrombo-embolic events developed after completion of the parent trial 1199.214/1199-0340:
Stroke;
Deep vein thrombosis;
Pulmonary embolism;
Myocardial infarction.
Major surgery performed within the next 3 months
Time period \> 12 weeks between last drug intake in 1199.214 or \> 1 week between last nintedanib intake in trial 1199-0340 and Visit 2 of this trial
Usage of any investigational drug after completion of 1199.214/1199-0340 or planned usage of an investigational drug during the course of this trial.
A disease or condition which may put the patient at risk because of participation in this trial (e.g. clinically relevant intestinal pseudoobstruction) or limit the patient's ability to participate in this trial
Chronic alcohol or drug abuse or any condition that, in the investigator's opinion, makes them an unreliable trial subject or unlikely to complete the trial
Known hypersensitivity to the trial medication or its components (i.e. soya lecithin).
Women who are pregnant, nursing, or who plan to become pregnant while in the trial
Previous enrolment in this trial

Intervenciones

drug

Nintedanib

Administered twice daily

Ubicaciones

Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich

Buenos Aires, Argentina

APRILLUS-Asistencia e Investigación

Ciudad Autonoma Buenos Aires, Argentina

CEMER-Centro Medico De Enfermedades Respiratorias

Florida, Argentina

Patrocinadores

PrincipalBoehringer Ingelheim

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