Status:
COMPLETED
Digital Ischemic Lesions in Scleroderma Treated With Oral Treprostinil Diethanolamine
Lead Sponsor:
United Therapeutics
Conditions:
Systemic Sclerosis
Scleroderma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study will evaluate the effect of treprostinil diethanolamine (UT-15C) sustained release tablets(compared to placebo) on digital ulcers in patients with scleroderma. Treprostinil diethanolamine i...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
148 Patients enrolled
Trial Details
Trial ID
NCT00775463
Start Date
May 1 2009
End Date
July 1 2011
Last Update
December 28 2023
Active Locations (30)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Alabama - Arthritis Clinical Intervention Program
Birmingham, Alabama, United States, 35294
2
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259
3
UCLA
Los Angeles, California, United States, 90095
4
Stanford University School of Medicine/Palo Alto VA Health Care System
Palo Alto, California, United States, 94304