RIN-PH-202: An Open-Label Extension study of Inhaled Treprostinil in Subjects with Pulmonary Hypertension due to Parenchymal Lung Disease (INCREASE OL)
William Harvey, MD
Primary Investigator
Brief description of study
The purpose of this study is to evaluate the safety and efficacy of inhaled treprostinil in patients with pre-capillary pulmonary hypertension (PH) associated with interstitial lung disease (ILD) including combined pulmonary fibrosis and emphysema (CPFE).
Must have previously participated in study RIN-PH-201.
Detailed description of study
The purpose of this study is to provide or continue to provide inhaled treprostinil to subjects who completed RIN-PH-201.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: pulmonary hypertension,interstitial lung disease,combined pulmonary fibrosis and emphysema
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Age: 18 years - 80 years
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Gender: All
Inclusion Criteria
Participated in study RIN-PH-201 and:
a. remained on study drug and completed all scheduled study visits or
b. permanently discontinued study drug during the RIN-PH-201 study due to clinical worsening and completed all remaining required scheduled study visits or
c. was enrolled in study RIN-PH-201 at the time that the study study subject was discontinued by the sponsor.
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.
Males must use a condom for the duration of treatment and for at least 48 hours after discontinuing study drug.
Exclusion Criteria
Pregnant or lactating.
Was prematurely discontinued from study RIN-PH-201 due to treatment related AEs.
Was prematurely discontinued from study RIN-PH-201 duet to clinical worsening and did not undergo premature termination assessments prior to discontinuing study drug and/or did not complete all remaining study visits through the final scheduled visit.
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.
