PFF Clinical Trial Finder

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

Study Purpose

The main objective is to assess the potential influence of continuous intake of nintedanib on the systemic exposure of ethinylestradiol and levonorgestrel when administered in combination.

Recruitment Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
No

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Study Type
Interventional
Eligible Ages 18 Years and Over
Gender Female
More Inclusion & Exclusion Criteria

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 disease onset (defined by first non-Raynaud symptom) within 7 years - 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

Trial Details

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

Trial ID:
NCT03675581

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase
Phase 1

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
Boehringer Ingelheim

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator
N/A
Principal Investigator Affiliation N/A

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
Industry
Overall Status Recruiting
Countries Belgium, France, Germany, Netherlands, Portugal, Spain

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
Scleroderma, Systemic

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

UNIV UZ Gent, Gent, Belgium

Status

Recruiting

Address

UNIV UZ Gent

Gent, , 9000

Site Contact

Vanessa Smith

vanessa.smith@ugent.be

+32 (0)9 332 28 56

HOP Avicenne, Bobigny, France

Status

Recruiting

Address

HOP Avicenne

Bobigny, , 93009

Site Contact

Hilario Nunes

hilario.nunes@aphp.fr

+33 (0)1 48 95 51 21

HOP Bichat, Paris, France

Status

Recruiting

Address

HOP Bichat

Paris, , 75018

Site Contact

Bruno Crestani

bruno.crestani@aphp.fr

+33 (0)1 40 25 71 58

HOP Cochin, Paris, France

Status

Recruiting

Address

HOP Cochin

Paris, , 75679

Site Contact

Yannick Allanore

yannick.allanore@aphp.fr

+33 (0)1 58 41 25 72

Universitätsklinikum Erlangen, Erlangen, Germany

Status

Recruiting

Address

Universitätsklinikum Erlangen

Erlangen, , 91054

Medizinische Hochschule Hannover, Hannover, Germany

Status

Recruiting

Address

Medizinische Hochschule Hannover

Hannover, , 30625

Heidelberg, Germany

Status

Recruiting

Address

Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg

Heidelberg, , 69126

Site Contact

Michael Kreuter

kreuter@uni-heidelberg.de

+49 (6221) 3961201

Radboud Universitair Medisch Centrum, Nijmegen, Netherlands

Status

Recruiting

Address

Radboud Universitair Medisch Centrum

Nijmegen, , 6525 GL

Site Contact

Madelon Vonk

Madelon.Vonk@radboudumc.nl

+31(0)24-3611111

Hospital Garcia de Orta, EPE, Almada, Portugal

Status

Recruiting

Address

Hospital Garcia de Orta, EPE

Almada, , 2801-951

Site Contact

Ana Cordeiro

cordeiro.ana@gmail.com

+351 212 727 375

Hospital Fernando Fonseca, EPE, Amadora, Portugal

Status

Recruiting

Address

Hospital Fernando Fonseca, EPE

Amadora, , 2720-276

Site Contact

José Alves

jose.alves@fcm.unl.pt

00351 21 4345510

Ponte de Lima, Portugal

Status

Recruiting

Address

ULSAM, EPE - Hospital Conde de Bertiandos

Ponte de Lima, , 4990-041

Hospital Santa Creu i Sant Pau, Barcelona, Spain

Status

Recruiting

Address

Hospital Santa Creu i Sant Pau

Barcelona, , 08026

Site Contact

Iván Castellví Barranco

ICastellvi@santpau.cat

+34935565609

Hospital Vall d'Hebron, Barcelona, Spain

Status

Recruiting

Address

Hospital Vall d'Hebron

Barcelona, , 08035

Site Contact

Alfredo Guillén

alguille@vhebron.net

+34932746003

Terms of Service

The PFF does not promote or represent that any investigational new drugs mentioned are safe or effective. The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. For a full description of terms please refer to our Terms, Conditions & Privacy.

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