An Open Label Extension Study to Evaluate Inhaled Treprostinil in Adult PH With ILD Including CPFE

United Therapeutics

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Combined Pulmonary Fibrosis and Emphysema; Pulmonary Hypertension; Interstitial Lung Disease

Treatments: Drug: Inhaled Treprostinil

Study type: Interventional

Funder types: Industry

Identifiers

NCT02633293

RIN-PH-202

Details and patient eligibility

About

This is a multicenter, open-label trial to evaluate the safety and efficacy of inhaled treprostinil in subjects with pre-capillary pulmonary hypertension (PH) associated with interstitial lung disease (ILD) including combined pulmonary fibrosis and emphysema (CPFE). The study will include about 266 patients who completed all required assessments in the RIN-PH-201 study at approximately 100 clinical trial centers. The study will continue Your participation in this study is voluntary and will last until you discontinue from the study or the study ends. The study will continue until each subject reaches the Week 108 visit or until inhaled treprostinil become commercially available for patients with PH associated with ILD including CPFE (whichever is sooner).

Enrollment: 243 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subject voluntarily gives informed consent to participate in the study.

2. The subject participated in study RIN-PH-201, remained on study drug, was compliant with RIN-PH-201 study procedures or was enrolled in study RIN-PH-201 at the time that the study was discontinued by the sponsor.

3. Females of reproductive potential must be non-pregnant (as confirmed by a urine pregnancy test at Baseline) and non-lactating, and will:

   • Either abstain from intercourse (when it is in line with their preferred and usual lifestyle), or
   • Use two medically acceptable, highly-effective forms of contraception for the duration of study, and at least 30 days after discontinuing study drug.

4. Males must use a condom for the duration of treatment and for at least 48 hours after discontinuing study drug.

Exclusion criteria

1. The subject is pregnant or lactating.
2. The subject was prematurely discontinued from study RIN-PH-201.
3. The subject developed a concurrent illness or condition during the conduct of RIN-PH-201 which, in the opinion of the Investigator, would represent a risk to overall health if they enrolled in this study.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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243 participants in 1 patient group

Inhaled Treprostinil

Experimental group

Description:

Open-label access

Treatment:

Drug: Inhaled Treprostinil