Systemic Sclerosis, scleroderma digital ulcers MedDRA version: 14.0 Level: PT Classification code 10039710 Term: Scleroderma System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 14.0 Level: PT Classification code 10042953 Term: Systemic sclerosis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Sponsors
United Therapeutics Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Eligible subjects who completed assessments in the final visit of the previous controlled trials (TDE-DU-201 and TDE-DU-301), and who signed appropriate informed consent, are eligible to enroll in this extension study. 2) If a female of childbearing potential, the subject must agree 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). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients must not: 1) 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; 2) Have been found to be unable to complete study assessments in the previous controlled trial; 3) Have prematurely discontinued study drug during the previous study (TDE-DU-201 or TDE-DU-301) due to treatment related adverse events
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Provide, or continue to provide, treprostinil diethanolamine SR for eligible subjects who participated in protocols TDE-DU-201 or TDE-DU-301* * Protocol TDE-DU-301 is planned to be submitted at a future date;Secondary Objective: 1) Assess the long-term safety of treprostinil diethanolamine SR through assessment of adverse events and laboratory parameters. 2) Assess long-term dosing patterns and the effect, if any, of temporary reduction and re-titration of dosing in subjects. 3) Assess the effect of continued therapy with treprostinil diethanolamine SR on digital ulcers and measures of patient function, SHAQ and CHFS, with long-term treatment. ;Primary end point(s): Adverse events and Clinical Laboratory parameters;Timepoint(s) of evaluation of this end point: Adverse events will be reported continuously and clinical laboratory parameters will be assessed at weeks 4, 6, 8/10 and 12 | — |
Countries
Canada, United Kingdom, United States
Contacts
Public ContactRegulatory Department
United Therapeutics Europe Ltd
Outcome results
None listed