Digital Ischemic Lesions in Scleroderma Treated With Oral Treprostinil Diethanolamine: An Open-label Multicenter Extension Study

TDE-DU-202

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.

2009-09-01

2011-09-01

2011-09-01

Terminated

Early phase I

115

Inclusion Criteria: * 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). Exclusion Criteria: * 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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 115, 'type': 'ACTUAL'}}

2024-06-18