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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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29 May 2023 |
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Main ID: |
NCT03814317 |
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Date of registration:
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04/01/2019 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Inhaled Treprostinil in Sarcoidosis Patients With Pulmonary Hypertension
SAPPHIRE |
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Scientific title:
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An Open-Label Study of Inhaled Treprostinil in Sarcoidosis Patients With Pulmonary Hypertension and Interstitial Lung Disease (SAPPHIRE) |
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Date of first enrolment:
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January 30, 2020 |
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Target sample size:
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10 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03814317 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Christina M Eagan, DNP |
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Christina M Eagan, DNP |
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Address:
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Telephone:
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352-273-8990 |
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Email:
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christina.eagan@medicine.ufl.edu |
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Affiliation:
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Name:
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Ali Ataya, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Florida |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Patient on any prostanoid or prostanoid analog therapy
- Patients with left sided heart disease as defined by either a PCWP > 15 mmHg and/or
left ventricular ejection fraction < 40%
- Use of any investigational drug/device, or participation in any investigational study
with therapeutic intent within 30 days prior to randomization.
Age minimum:
18 Years
Age maximum:
99 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Interstitial Lung Disease
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Precapillary Pulmonary Hypertension
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Sarcoidosis
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Intervention(s)
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Drug: Inhaled Treprostinil
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Primary Outcome(s)
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mPAP by Right heart catheterization (RHC)
[Time Frame: Baseline, Week 16]
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PVR by Right heart catheterization (RHC)
[Time Frame: Baseline, Week 16]
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Secondary Outcome(s)
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Change in Brain Natriuretic Peptide (BNP)
[Time Frame: Baseline, Week 16]
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Change in WHO Functional Class (WHO FC)
[Time Frame: Baseline, Week 8, Week 16]
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Change in 6-Minute Walk Test (6MWT)
[Time Frame: Baseline, Week 8, Week 16]
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Change in Cardiac MRI parameters
[Time Frame: Baseline, Week 16]
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Change in Pulmonary Function Testing
[Time Frame: Baseline, Week 16]
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Secondary ID(s)
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20192572
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OCR19684
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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