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NCT02426229 · ClinicalTrials.gov registry record · Phase 1
Safety & Suitability of Dabigatran to Inhibit Thrombin in Scleroderma
A Phase 1 study, sponsored by Medical University of South Carolina.
- Completed
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
NCT02426229: Completed Phase 1 study, sponsored by Medical University of South Carolina.
NCT02426229 is a Phase 1 study that has completed, run by Medical University of South Carolina. The registered enrollment target is 15 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02426229, a Phase 1 study, has completed, sponsored by Medical University of South Carolina.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
Study 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.
Primary Outcome
Subjects taking dabigatran will undergo monthly complete blood counts (white blood cell count, hemoglobin, hematocrit, platelet), comprehensive metabolic profile (sodium, potassium, chloride, bicarbonate, BUN, creatinine, glucose, total bilirubin, AST, ALT, alkaline phosphatase, protein and albumin), and coagulation studies (prothrombin time, partial thromboplastin time and thrombin time). Women of child-bearing age will be required to have a urine pregnancy test monthly while receiving dabigatr
Interventions
- DRUG dabigatran etexilate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2016-02 |
| Est. Completion | 2018-06-21 |
| Phase | Phase 1 |
What the finished NCT02426229 record still lists
NCT02426229 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 1 intervention - of which dabigatran etexilate is the first listed.
NCT02426229 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02426229 about?
NCT02426229 is a clinical study titled "Safety & Suitability of Dabigatran to Inhibit Thrombin in Scleroderma". 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.
What is the current status of trial NCT02426229?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2016-02. Estimated completion is 2018-06-21.
What interventions are being tested in trial NCT02426229?
The interventions under investigation include: dabigatran etexilate (DRUG).
Who is sponsoring clinical trial NCT02426229?
This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02426229's enrollment target sits among peer trials
15 1798th of 2000 higher than 157 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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