Safety & Suitability of Dabigatran to Inhibit Thrombin in Scleroderma

Status Completed

Clinical Trial Summary

This study evaluates if dabigatran etexilate is safe for use in patients with Scleroderma and Interstitial Lung Disease. All patients will receive 75mg of dabigatran etexilate twice a day for 6 months.

Clinical Trial Description

Skin and pulmonary fibrosis result in substantial morbidity in scleroderma (SSc). Furthermore, interstitial lung disease (ILD) culminating in pulmonary fibrosis is a major cause of death among scleroderma patients. Studies implicate the coagulation system, most notably the serine protease thrombin, in the pathogenesis of SSc-ILD. Thrombin can transform normal lung fibroblasts to a scleroderma fibroblast phenotype. Dabigatran etexilate is a selective thrombin inhibitor which is FDA-approved for the prevention of thromboembolic complications in patients with atrial fibrillation. Dabigatran etexilate needs to be studied as a potential anti-fibrotic agent for the treatment of SSc-ILD. This study is designed to see if dabigatran etexilate is safe for use in patients with scleroderma. If so, the long term goal of this study is to determine whether or not the fundamental results will translate to a potential clinical intervention for SSc-ILD which can be tested in a future randomized control trial. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02426229
Study type	Interventional
Source	Medical University of South Carolina
Contact
Status	Completed
Phase	Phase 1
Start date	February 2016
Completion date	June 21, 2018

View Details

See also
Status	Clinical Trial	Phase
Enrolling by invitation	`NCT04905693` - Extension Study of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis	Phase 3
Recruiting	`NCT05631132` - May Noninvasive Mechanical Ventilation (NIV) and/or Continuous Positive Airway Pressure (CPAP) Increase the Bronchoalveolar Lavage (BAL) Salvage in Patients With Pulmonary Diseases?	N/A
Recruiting	`NCT05417776` - Collagen-targeted PET Imaging for Early Interstitial Lung Disease	Phase 2
Not yet recruiting	`NCT04089826` - Long Term Oxygen Therapy in Patients With Interstitial Lung Disease
Recruiting	`NCT03467880` - Multicenter Study of Impulse Oscillometry in Chinese	N/A
Completed	`NCT00883129` - Comparison of Therapeutic Regimens for Scleroderma Interstitial Lung Disease (The Scleroderma Lung Study II)	Phase 2
Completed	`NCT00362739` - Blood Collection From Individuals With Lung Disease for Genetic Studies	N/A
Recruiting	`NCT06133998` - Effects of Incentive Spirometry With and Without Aerobic Exercises in Interstitial Lung Disease	N/A
Active, not recruiting	`NCT03485378` - Assessment of Precision Irradiation in Early NSCLC and Interstitial Lung Disease	N/A
Recruiting	`NCT04098094` - Outcomes of RV Dysfunction in Acute Exacerbation of Chronic Respiratory Diseases
Recruiting	`NCT03400839` - Best Clinical Endpoints That Likely Induce Worse Prognosis in Interstitial Lung Diseases
Terminated	`NCT02633293` - An Open Label Extension Study to Evaluate Inhaled Treprostinil in Adult PH With ILD Including CPFE	Phase 2/Phase 3
Enrolling by invitation	`NCT05001009` - Goals of Care Conversations Study	N/A
Active, not recruiting	`NCT05068869` - Digital Outpatient Services	N/A
Active, not recruiting	`NCT03727568` - Study Comparing Two Different Methods of Cryobiopsy in the Interstitial Lung Diseases	N/A
Recruiting	`NCT06046547` - Integrating Palliative Care Education in Pulmonary Rehabilitation	N/A
Completed	`NCT04946708` - Virtual Exercise Program in Interstitial Lung Disease (ILD) Patients	N/A
Recruiting	`NCT04139356` - The Effect of Spontaneous Respiration on Pulse-oximetry Measurements	N/A
Recruiting	`NCT03726398` - CompRehensive Phenotypic Characterization of Patients With Scleroderma-Associated ILD and PH	Phase 2/Phase 3
Active, not recruiting	`NCT03295279` - WTC Chest CT Imaging Archive