Raynaud's Disease study: Oral treprostinil
Official title Open Label Treprostinil Raynaud's Study
ClinicalTrials.gov ID: NCT07112183
What this study is testing
What is Oral treprostinil (UT-15C) sustained release tablets?
Oral treprostinil (UT-15C) sustained release tablets is an investigational medicine, taken by mouth once daily, being studied as a potential treatment for raynaud's disease.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether oral treprostinil can help with severe Raynaud's. It looks at how well this pill works for people who did not get better with usual care.
- Who it's for
- You may be able to join if you have severe Raynaud's that has not responded to standard treatments.
- What's involved
- You would take a pill called oral treprostinil. This medicine helps open blood vessels to improve blood flow.
- Time commitment
- The source text does not say how long the study lasts or what visits are needed.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients aged ≥ 18 years
- Active Raynaud's Phenomenon defined as patients with refractory RP having four or more RP attacks per week in the 4 weeks before inclusion in the...
- Primary Raynaud's Phenomenon
- Patients with Raynaud's secondary to connective tissue diseases (including scleroderma (SSc), limited scleroderma (CREST), mixed connective tissue...
- If patients are on phosphodiesterase inhibitors (sildenafil, tadalafil or vardenafil), endothelin antagonists, alpha adrenergic antagonists, or...
You likely can't join if
- Uncontrolled hypertension, diabetes mellitus, acute coronary or cerebrovascular event within 3 months, history of sympathectomy
- Smoking within 3 months or smoking cessation using nicotine products
- History of alcohol or other substance abuse within the previous year
- people with diverticulosis confirmed via endoscopic evaluation of the sigmoid colon with at least three diverticula noted
- people with moderate to severe liver disease, Child Pugh Class B or C
- people currently taking any other prostacyclin.
See the full eligibility criteria
- Patients aged ≥ 18 years
- Active Raynaud's Phenomenon defined as patients with refractory RP having four or more RP attacks per week in the 4 weeks before inclusion in the study.
- Primary Raynaud's Phenomenon
- Patients with Raynaud's secondary to connective tissue diseases (including scleroderma (SSc), limited scleroderma (CREST), mixed connective tissue disease (MCTD), primary Sjogren's syndrome (SS), systemic lupus...
- If patients are on phosphodiesterase inhibitors (sildenafil, tadalafil or vardenafil), endothelin antagonists, alpha adrenergic antagonists, or calcium channel blockers, their dose must be stable, defined as 3-months...
- If female of childbearing potential (FOCP), has demonstrated a negative beta HCG (human chorionic gonadotropin) serum pregnancy test, and agrees to comply with any applicable contraceptive requirements of the protocol
- Is in a postmenopausal state defined as no menses for 12 months without an alternative medical cause and follicle-stimulating hormone (FSH) level consistent with postmenopause (\>25 mIU/mL).
- Has a documented hysterectomy, bilaterial oophorectomy, or salpingectomy.
- Uncontrolled hypertension, diabetes mellitus, acute coronary or cerebrovascular event within 3 months, history of sympathectomy
- Smoking within 3 months or smoking cessation using nicotine products
- History of alcohol or other substance abuse within the previous year
- people with diverticulosis confirmed via endoscopic evaluation of the sigmoid colon with at least three diverticula noted
- people with moderate to severe liver disease, Child Pugh Class B or C
- people currently taking any other prostacyclin.
- Pregnant or breast feeding or considering pregnancy in next 4 months
- Was dosed in any clinical research study evaluating another investigational drug (including biologics) or therapy (including specific immunotherapy) within 30 days or 5 half-lives (whichever is longer) of an...
- Any serious chronic, and/or unstable pre-existing medical, surgical, psychiatric or other condition that could interfere with the participant's safety, obtaining informed consent, or compliance with study procedures per...
- Hospitalization for any indication within 7 days before the start of screening.
The study team makes the final eligibility decision.
Where it is enrolling
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Boston, Massachusetts, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.