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NCT07112183 · ClinicalTrials.gov registry record · Phase 4
Open Label Treprostinil Raynaud's Study
A Phase 4 study, sponsored by Brigham and Women's Hospital.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 30
- Enrollment target
NCT07112183 is a Phase 4 study that is actively recruiting participants, run by Brigham and Women's Hospital. The registered enrollment target is 30 participants.
The verdict
NCT07112183, a Phase 4 study, is actively recruiting participants, sponsored by Brigham and Women's Hospital.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 30 participants
- Enrollment target
Study Summary
Raynaud's phenomenon is a condition where the blood vessels in participants fingers and toes get too narrow when cold or stressed. This makes participants fingers and toes change colors - they might turn white, then blue, and finally red as blood flow returns. It can be painful and cause numbness or tingling. When participants have Raynaud's, blood vessels react too strongly to cold or stress. Fingers and toes may turn white (blood moves away from the area), blue (lack of oxygen), or red and feel painful or tingly when warming up. These episodes usually last from a few minutes to several hours. There are two types of Raynaud's. Primary Raynaud's (also called Raynaud's disease) itself and isn't connected to other health problems. It's the most common type and affects mostly women under 30. Secondary Raynaud's (also called Raynaud's phenomenon) is caused by other diseases like lupus, scleroderma, or rheumatoid arthritis. This type tends to be more serious and may cause painful sores on fingertips called digital ulcers. For mild cases, staying warm might be enough. But if symptoms are severe, participants doctor might prescribe various medications including calcium channel blockers - blood pressure medicines that help open blood vessels, or other vasodilators - medicines that widen blood vessels. About 40% of people with scleroderma develop painful sores on their fingertips called digital ulcers. These happen when there isn't enough blood flow to heal small injuries. For severe cases with digital ulcers, doctors might use prostacyclin therapy - medicines that mimic a natural substance that opens blood vessels. Oral treprostinil is a newer pill form of prostacyclin therapy that helps improve blood flow. The investigators are conducting a research study testing whether oral treprostinil - a pill that mimics prostacyclin (a natural blood vessel opener) - can help people with severe Raynaud's that doesn't respond to usual treatments. This represents hope for better tre
Interventions
- DRUG Oral treprostinil (UT-15C) sustained release tablets
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2025-10-15 |
| Est. Completion | 2029-03-01 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07112183
The ClinicalTrials.gov registry entry for NCT07112183 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Brigham and Women's Hospital, which has 937 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Oral treprostinil (UT-15C) sustained release tablets is the first listed.
NCT07112183 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07112183 about?
NCT07112183 is a clinical study titled "Open Label Treprostinil Raynaud's Study". Raynaud's phenomenon is a condition where the blood vessels in participants fingers and toes get too narrow when cold or stressed. This makes participants fingers and toes change colors - they might turn white, then blue, and finally red as blood flow returns. It can be painful and cause numbness or...
What is the current status of trial NCT07112183?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 30 participants. The study started on 2025-10-15. Estimated completion is 2029-03-01.
What interventions are being tested in trial NCT07112183?
The interventions under investigation include: Oral treprostinil (UT-15C) sustained release tablets (DRUG).
Who is sponsoring clinical trial NCT07112183?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
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