Digital Ischemic Lesions in Scleroderma Treated With Oral Treprostinil Diethanolamine

Completed · Phase 2 · Has a placebo group

Conditions studied: Systemic Sclerosis, Scleroderma

In brief

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 is an analog of prostacyclin. Prostacyclin is a naturally occuring substance produced by the cells of blood vessels that inhibits platelet aggregation, induces vasodilation, and suppresses smooth muscle proliferation. Improvement in blood flow in lower limbs and fingers would be anticipated to result in a reduction in ischemic pain, Raynaud's phenomenon and promote healing of digital ulcers and other ischemic wounds.

Key facts

Study ID

NCT00775463

Run by

United Therapeutics

People needed

148

Starts

2009-05-01

Expected to finish

2011-07-01

Last updated by the study team

2023-12-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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

Where it is running

• University of Alabama - Arthritis Clinical Intervention Program — Birmingham, Alabama, United States
• Mayo Clinic Scottsdale — Scottsdale, Arizona, United States
• UCLA — Los Angeles, California, United States
• Stanford University School of Medicine/Palo Alto VA Health Care System — Palo Alto, California, United States
• Denver Medical Center — Aurora, Colorado, United States
• University of Connecticut Health Center — Farmington, Connecticut, United States
• Georgetown University — Washington D.C., District of Columbia, United States
• Northwestern University - Feinberg School of Medicine — Chicago, Illinois, United States
• University of Indiana School of Medicine — Indianapolis, Indiana, United States
• Johns Hopkins University - Division of Rheumatology — Baltimore, Maryland, United States
• Boston University School of Medicine — Boston, Massachusetts, United States
• University of Michigan Scleroderma Program — Ann Arbor, Michigan, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• UMDNJ Clinical Research Center — New Brunswick, New Jersey, United States
• North Shore-LIJ Health System — Lake Success, New York, United States
• The Hospital for Special Surgery — New York, New York, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• University of Toledo — Toledo, Ohio, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• University of Texas - Houston — Houston, Texas, United States
• University of Utah — Salt Lake City, Utah, United States
• Virginia Mason Medical Center — Seattle, Washington, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States
• Dalhousie University - QEII Health Science Center — Halifax, Nova Scotia, Canada

Full record on ClinicalTrials.gov

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