RIN-PH-202: An Open-Label Extension study of Inhaled Treprostinil in Subjects with Pulmonary Hypertension due to Parenchymal Lung Disease (INCREASE OL)

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William Harvey, MD

Primary Investigator

Overview

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.

Description

The purpose of this study is to provide or continue to provide inhaled treprostinil to subjects who completed RIN-PH-201.

Eligibility

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    pulmonary hypertension,interstitial lung disease,combined pulmonary fibrosis and emphysema
  • Age: Between 18 Years - 80 Years
  • 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.


Additional Information:

Updated on 20 Nov 2022. Study ID: 1602009433

Interested in the study?

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