Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
United Therapeutics
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Subject gave voluntary written informed consent to participate in the study
Diagnosis of systemic sclerosis (SSc) as defined by American College of Rheumatology (ACR) criteria
Males and females age greater than 18 years at Screening
Presence of at least one active digital ulcer (met protocol defined qualifications for active digital ulcer) at Baseline
Females of childbearing potential willing to use a reliable form of medically acceptable contraception and have a negative pregnancy test at Screening and Baseline
Able to communicate effectively with study personnel and willing to comply with protocol requirements
You may not be if
Diagnosis of pulmonary arterial hypertension (PAH)
Body weight less than 40 kg at Screening and confirmed at Baseline
History of postural hypotension, unexplained syncope, a blood pressure that is less than 90 mmHg systolic or 50 mmHg diastolic at Screening and Baseline
Hemoglobin concentration less than 75% of the lower limit of the normal range at Screening
Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C, or ALT greater than three times upper limit of normal
Intractable diarrhea, or severe malabsorption, defined as greater than 15% unintentional loss of body weight in the last 6 months prior to Screening; any severe organ failure (e.g., lung, kidney), bleeding diathesis or platelet disorder, or any life-threatening condition
Pregnant or breast-feeding
Simultaneously fulfilled criteria for a second connective tissue disease including systemic lupus erythermatosus, rheumatoid arthritis or inflammatory myopathy
Sympathectomy of the upper limb, involving the hand, performed within 12 months of Baseline. Sympathectomy performed on the non-target limb (hand not presenting with qualifying ulcers) or which did not include the hand, performed within 6 months of Baseline
Receipt of prostanoid treatment (epoprostenol, treprostinil sodium, or other prostacyclin analog) within the previous 3 months of Baseline for conditions including Raynaud's phenomenon, rest pain and / or digital ulcers
Required systemic antibiotics for infected digital ulcers within 2 weeks of Screening
Local injection of botulinum toxin in an affected finger within 1 month prior to Baseline
Treatment with endothelin receptor antagonists within 1 month prior to Baseline
Patients on phosphodiasterase inhibitors, such as sildenafil or tadalafil, who have received treatment for less than 6 months prior to Baseline (unless for intermittent treatment of male erectile dysfunction)
Treatment with statin within 1 month prior to Screening, unless for management of hyperlipidemia
Received an investigational product within 1 month preceding Screening
Known hypersensitivity to treprostinil diethanolamine or any of the excipients
Tobacco or nicotine use at any level within the past 6 months prior to Screening
Any condition or laboratory that in the opinion of the investigator might interfere with subject's participation, pose an additional risk for the subject, could prevent understanding the objectives, nature or consequences of the trial, compliance with the protocol, adherence to therapy, or that would interfere with interpretation of study assessments
Clareo Health | Digital Ischemic Lesions in Scleroderma Treated With Oral Treprostinil Diethanolamine
