Last updated on December 2019

A Study to Test Whether Nintedanib Influences the Components of Birth-control Pills in Women With Systemic Sclerosis Associated Interstitial Lung Disease (SSc-ILD)

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Systemic sclerosis
  • Age: Between 18 - 100 Years
  • Gender: Female

Inclusion Criteria:

  • Age >= 18 years
  • A woman of non-child bearing potential, i.e. being postmenopausal1 or permanently sterilised (e.g. hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or a woman of childbearing potential correctly and consistently using a highly effective method of non-hormonal birth control (i.e. IUD or bilateral tubal ligation) together with barrier methods at least 30 days prior to first administration of Microgynon (Visit 2), during the trial and for 3 months after last intake of nintedanib.
  • 2013 American College of Rheumatology (ACR) / European League against Rheumatism (EULAR) classification criteria for Systemic Sclerosis associated Interstitial Lung Disease (SSc) fulfilled
  • SSc related Interstitial Lung Disease confirmed by High Resolution Computer Tomography (HRCT); Extent of fibrotic disease in the lung >= 10%
  • Forced Vital Capacity (FVC) >= 40% of predicted normal
  • Carbon Monoxide Diffusion Capacity (DLCO) 30% to 89% of predicted normal
  • Further inclusion criteria apply

Exclusion criteria:

  • Aspartate Transaminase (AST), Alanine Transaminase (ALT) >1.5 x Upper Level of Normal (ULN).
  • Bilirubin >1.5 x ULN
  • Creatinine clearance <30 mL/min
  • Clinically relevant anaemia at investigators discretion
  • Airway obstruction (pre-bronchodilator Forced Expiratory Volume in 1 second (FEV1)/Forced Vital Capacity (FVC) <0.7)
  • Other clinically significant pulmonary abnormalities
  • Significant Pulmonary Hypertension (PH)
  • Cardiovascular diseases
  • More than 3 digital fingertip ulcers or a history of severe digital necrosis requiring hospitalization or severe other ulcers
  • Bleeding risk (such as predisposition to bleeding, fibrinolysis, full-dose anticoagulation, high dose antiplatelet therapy, history of hemorrhagic central nervous system (CNS) event within last year
  • International normalised ratio (INR) >2, prolongation of prothrombin time (PT) and partial thromboplastin time (PTT) by >1.5 x ULN)
  • History of thrombo-embolic event within last year
  • Previous or planned hematopoietic stem cell transplantation
  • Clinical signs of malabsorption or needing parenteral nutrition
  • Patients with underlying chronic liver disease (Child Pugh A, B, C hepatic impairment)
  • Previous treatment with nintedanib or pirfenidone
  • Further exclusion criteria apply

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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