NCT03814317CompletedPhase 2
Inhaled Treprostinil in Sarcoidosis Patients With Pulmonary Hypertension
An Open-Label Study of Inhaled Treprostinil in Sarcoidosis Patients With Pulmonary Hypertension and Interstitial Lung Disease (SAPPHIRE)
Source: ClinicalTrials.gov · Last updated 6 Feb 2026
Brief summary (registry, in English)
This study aims to evaluate the efficacy and safety of inhaled treprostinil in subjects with sarcoidosis-associated interstitial lung disease and pulmonary hypertension.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 5 (actual)
- First submitted
- 4 Jan 2019
- Start date
- 30 Jan 2020
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- University of Florida
- NCT number
- NCT03814317
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 5
- From 30 Jan 2020 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patient on any prostanoid or prostanoid analog therapy
- Use of any investigational drug/device, or participation in any investigational study with therapeutic intent within 30 days prior to randomization.
Lab values
- Patients with left sided heart disease as defined by either a PCWP \> 15 mmHg and/or left ventricular ejection fraction \< 40%
Other
- Pregnant patients or those who are actively lactating
- Patient not willing to use form of birth control (if applicable) during the study
- Inability to undergo 6MWT, RHC, PFTs or CMRI
- Predicted survival \< 6 months
Who the study is looking for
- Study participant willing and able to provide informed consent
- Negative urine pregnancy test at baseline for females of childbearing potential
- Established diagnosis of sarcoidosis by ATS/ERS/WASOG 1999 Statement on of Sarcoidosis
- Presence of interstitial lung disease by Scadding Stage IV chest radiograph or extensive fibrosis on chest computed tomography
- Right heart catheterization within six months of baseline visit showing precapillary pulmonary hypertension (mPAP ≥ 25 mmHg, PCWP ≤ 15 mmHg, and PVR \> 3 WU)
- Patient on stable sarcoidosis therapy for at least three months prior to screening
- If patients are on oral PAH therapy (PDE5i/SCGS and/or ERA) then dose should be stable for at least three months prior to screening
- A 6MWT within three months of screening visit of \> 100 meters
Age in the registry: 18 years to 99 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Florida, Division of Pulmonary and Critical Care Medicine Coordinator of this site? Confirm its status | Gainesville | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.