Open-Label Study of Oral Treprostinil in Digital Ulcers (DISTOL-EXT)

United Therapeutics

Status and phase: Terminated; Phase 2

Conditions: Systemic Sclerosis

Treatments: Drug: treprostinil diethanolamine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00848107

TDE-DU-202

Details and patient eligibility

About

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.

Enrollment: 115 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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115 participants in 1 patient group

Treprostinil

Experimental group

Description:

Treprostinil diethanolamine sustained release tablet initiated at 0.25 mg and titrated up to a maximum dose of 16 mg BID or the individual's maximum tolerated dose (MTD).

Treatment:

Drug: treprostinil diethanolamine