drugset / Trial / NCT02426229
Safety & Suitability of Dabigatran to Inhibit Thrombin in Scleroderma
Phase 1
Completed
15 enrolled
Medical University of South Carolina
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) · collab
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2016-02
- Primary completion
- 2018-06
- Completion
- 2018-06-21
Publications
- Background Bogatkevich GS, Ludwicka-Bradley A, Silver RM. Dabigatran, a direct thrombin inhibitor, demonstrates antifibrotic effects on lung fibroblasts. Arthritis Rheum. 2009 Nov;60(11):3455-64. doi: 10.1002/art.24935.
- Bogatkevich GS, Huggins TJ, Ismail AA, Atanelishvili I, Silver RM. Anti-fibrotic effects of thrombin inhibition in systemic sclerosis-associated interstitial lung disease: Proof of concept. J Scleroderma Relat Disord. 2025 Feb 24;10(3):359-367. doi: 10.1177/23971983241311625. eCollection 2025 Oct.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dabigatran etexilate | Unknown | 75 mg | Oral |