Open-Label Study of Oral Treprostinil in Digital Ulcers

Stopped early · Phase 2

Conditions studied: Systemic Sclerosis

In brief

This open label extension trial will allow ongoing treatment of subjects who participated in the randomized controlled trials, and will provide long term information about the safety of treprostinil diethanolamine SR in subjects with SSc and digital ulcers.

Key facts

Study ID

NCT00848107

Run by

United Therapeutics

People needed

115

Starts

2009-09-01

Expected to finish

2011-09-01

Last updated by the study team

2024-06-18

Who can join

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

You may qualify if…

• Eligible subjects who completed assessments for the final visit of the previous TDE-DU-201 controlled trial and who signed appropriate informed consent were eligible to enroll in this extension study.
• If a female of childbearing potential, the subject must have agreed to continue practicing an acceptable method of birth control (i.e., surgical sterilization, approved hormonal contraceptives, barrier methods [such as a condom or diaphragm] used with a spermicide, or an intrauterine device).

You may not qualify if…

• Have had any change in clinical status that, in the opinion of the Investigator, would pose a safety risk for participation in this extension study;
• Have been found to be unable to complete study assessments in the previous controlled trial;
• Have prematurely discontinued study drug during the previous study due to clinical worsening or treatment related adverse events.

Where it is running

• University of Alabama - Birmingham - Arthritis Clinical Intervention Program — Birmingham, Alabama, United States
• Mayo Clinic Scottsdale — Scottsdale, Arizona, United States
• UCLA — Los Angeles, California, United States
• Barbara Davis Centre — Aurora, Colorado, United States
• University of Connecticut Health Center — Farmington, Connecticut, United States
• Georgetown University - Dept. of Medicine/Rheumatology — Washington D.C., District of Columbia, United States
• Northwestern University - Feinberg School of Medicine — Chicago, Illinois, 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
• The 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 — Seattle, Washington, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States
• St Joseph's Health Care — London, Ontario, Canada
• Jewish General Hospital — Montreal, Quebec, Canada
• Royal Free Hospital - Center for Rheumatology — London, United Kingdom

Full record on ClinicalTrials.gov

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