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NCT02663895 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of Oral Treprostinil in the Treatment of Calcinosis in Patients With Systemic Sclerosis
A Phase 2 study, sponsored by Stanford University.
- Completed
- Registry status
- Phase 2
- Development phase
- 12
- Enrollment target
NCT02663895: Completed Phase 2 study, sponsored by Stanford University.
NCT02663895 is a Phase 2 study that has completed, run by Stanford University. The registered enrollment target is 12 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02663895, a Phase 2 study, has completed, sponsored by Stanford University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 12 participants
- Enrollment target
Study Summary
This is a prospective open-label trial that will enroll 12 patients with systemic sclerosis (SSc) and at least one calcinotic lesion of the hands that is palpable on physical examination and also measureable on hand radiographs, at one single center. Each subject will receive treprostinil orally for 12 months, and follow-up evaluations will be performed every 3 months. Our main objective is to determine whether oral treprostinil is safe, and effective in reducing calcinosis in patients with SSc. We hypothesize that calcinosis is a result of microvascular injury and ischemic damage, and that therefore treprostinil may be beneficial in the treatment of calcinosis in patients with SSc.
Interventions
- DRUG Oral treprostinil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2016-10 |
| Est. Completion | 2020-05-13 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02663895
The ClinicalTrials.gov registry entry for NCT02663895 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Stanford University, which has 1,744 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Oral treprostinil is the first listed.
NCT02663895 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02663895 about?
NCT02663895 is a clinical study titled "Safety and Efficacy of Oral Treprostinil in the Treatment of Calcinosis in Patients With Systemic Sclerosis". This is a prospective open-label trial that will enroll 12 patients with systemic sclerosis (SSc) and at least one calcinotic lesion of the hands that is palpable on physical examination and also measureable on hand radiographs, at one single center. Each subject will receive treprostinil orally for...
What is the current status of trial NCT02663895?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2016-10. Estimated completion is 2020-05-13.
What interventions are being tested in trial NCT02663895?
The interventions under investigation include: Oral treprostinil (DRUG).
Who is sponsoring clinical trial NCT02663895?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
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