EXPEDITE: A Study of Remodulin Induction Followed by Orenitram Optimization to Treat Pulmonary Arterial Hypertension

  • STATUS
    Recruiting
  • days left to enroll
    63
  • participants needed
    35
  • sponsor
    United Therapeutics
Updated on 23 March 2022
hypertension
hysterectomy
medical therapy
immunodeficiency
heart disease
connective tissue disease
hypertrophy
treprostinil
remodulin
left ventricular end-diastolic pressure
appetite suppressants

Summary

This is a multicenter, open-label study to evaluate the dose of Orenitram® (treprostinil) Extended Release Tablets achieved at 16 weeks after a short-term course of Remodulin® (treprostinil) Injection in subjects with pulmonary arterial hypertension (PAH).

Description

Subjects will be initiated on subcutaneous (SC) or intravenous (IV) treprostinil and titrated to a dose that improves the symptoms of PAH while minimizing excessive pharmacologic effects. After achieving a minimum SC/IV treprostinil dose of 20 ng/kg/min, subjects may begin a transition to oral treprostinil at the Transition Visit, which can occur at the Week 2, 4, or 8 study visit. After the Transition Visit, oral treprostinil titration will continue through Week 16 to reach the maximum tolerated dose.

Details
Condition Pulmonary Arterial Hypertension
Treatment Intravenous/Subcutaneous Treprostinil; Oral Treprostinil
Clinical Study IdentifierNCT03497689
SponsorUnited Therapeutics
Last Modified on23 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Subjects who voluntary give written informed consent to participate in study
Males and female subjects aged 18 to 75 years at Screening (date the subject provides written informed consent to participate in study)
Subjects with a diagnosis of WHO Group 1 pulmonary hypertension: symptomatic idiopathic or heritable PAH; or PAH associated with connective tissue disease, human immunodeficiency virus (HIV) infection, repaired congenital systemic-to-pulmonary shunt (at least 1 year since repair with respect to the date of providing informed consent), or appetite suppressant/toxin use
Subjects with WHO FC II or III symptoms at Baseline
Subjects with 6MWD >250 meters at Baseline
Subjects who are either not receiving PAH-targeted therapy or are currently being treated with 1 or 2 oral FDA-approved PAH therapies consisting of an endothelin receptor antagonist (ERA) and/or either a phosphodiesterase type-5 inhibitor (PDE5-I) or a soluble guanylate cyclase (sGC) stimulator for ≥45 days, and on a stable dose for ≥30 days prior to the Baseline Visit
Subjects should be on stable doses of other medical therapies for at least 10 days prior to the Baseline Visit, with no dose adjustments, additions, or discontinuations. Exceptions to this are discontinuation or dose changes of anticoagulants and/or diuretics. Subjects should not have experienced recent changes to non-pharmacologic interventions, such as exercise, diet plans, pulmonary rehabilitation, sleep apnea treatment, etc for at least 10 days prior to Baseline Visit
Subjects with historical right-heart catheterization (RHC) with results consistent with WHO Group 1 PAH, as demonstrated by pulmonary artery pressure mean of ≥25 mmHg, a pulmonary artery wedge pressure (PAWP) or left ventricular end-diastolic pressure ≤15 mmHg if a PAWP measurement is not available, and a PVR >3 Wood units, in the absence of unrepaired congenital heart disease (other than patent foramen ovale)
Subject has undergone a RHC within 180 days of Baseline and had a cardiac index ≥2.0 L/min/m^2 with no changes in their PAH medication regimen (ie, both dosing and drug) since the RHC
Subjects in whom their most recent historical echocardiography demonstrates clinically normal left systolic and diastolic ventricular function and absence of any clinically significant left-sided heart disease. Subjects with clinically insignificant left ventricular diastolic dysfunction due to the effects of right ventricle (RV) overload (RV hypertrophy and/or RV dilation) are eligible
Subjects who agree to follow the specified precautions to avoid pregnancy as follows
Subjects who are females of childbearing potential include any female subject who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal (defined as amenorrhea for at least 12 consecutive months). For female subjects of childbearing potential, a negative urine pregnancy test is required at Screening and Baseline prior to initiating study drug. Female subjects of childbearing potential must follow 1 of the following
approaches
Practice actual abstinence from intercourse
Have a partner with a vasectomy
Have an intrauterine device
Must use 2 different forms of highly effective contraception for the duration of the study, and for at least 48 hours after discontinuing study drug. Medically acceptable forms of effective contraception include approved hormonal contraceptives (such as birth control pills) or barrier methods (such as a condom or diaphragm)
Male subjects with a partner of childbearing potential must use a condom during
intercourse for the duration of the study, and for 48 hours after
Subjects who, in the opinion of the Investigator, are capable of communicating effectively with study personnel and are considered reliable, willing, and likely to be cooperative with protocol requirements and attend all required study visits
discontinuing study drug
Subjects who have the capability to answer surveys and questionnaires written in English
Human immunodeficiency virus-positive subjects must have a CD4 lymphocyte count of at
least 200 cells/mm^3 within 30 days of Screening and be receiving current
standard of care anti-retroviral or other effective medication for the
treatment of HIV, with no changes for at least 8 weeks prior to enrollment

Exclusion Criteria

Female subjects who are pregnant, lactating, or planning to become pregnant during the study
Subjects with a current diagnosis of uncontrolled sleep apnea, as defined by their physician
Subjects with renal insufficiency, as defined by requiring dialysis or an estimated creatinine clearance of <30 mL/min, as calculated by the Cockcroft-Gault equation
Subjects with anemia, as defined by Screening hemoglobin <9 g/dL
Subjects with an active infection or condition that would interfere with interpretation of study assessments
Subjects with a history of ischemic heart disease (defined as subjects who require anti-anginal therapy within 6 months of Screening or who have experienced a documented myocardial infarction within 6 months of Screening), or a history of left-sided myocardial dysfunction, as evidenced by a PAWP >15 mmHg or left ventricular ejection fraction <50%
Subjects with uncontrolled systemic hypertension, as evidenced by systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg at Baseline
Subjects with severe hypotension, as evidenced by systolic blood pressure <90 mmHg or diastolic blood pressure <50 mmHg at Baseline
Subjects with liver dysfunction defined as elevated liver function tests (alanine aminotransferase or aspartate aminotransferase) ≥3 times the upper limit of normal at Screening, or subjects with Child-Pugh Class B or C hepatic disease
If a lung assessment has been completed as per standard of care, any subject with 1 or more of the following signs of documented relevant lung disease within 180 days of Baseline: total lung capacity <60% of predicted, or forced expiratory volume in 1 second <55% of predicted normal
Subjects with chronic musculoskeletal disorder or any other disease that would limit ambulation, or who are connected to a machine that is not portable
Subjects with a history of alcohol abuse or illicit drug abuse within 12 months of Baseline which, in the Investigator's opinion, would make the subject inappropriate for enrollment in a clinical study
Subjects with any other concomitant disease with life expectancy of <12 months from Baseline
Subjects with an unstable psychiatric condition or those not capable of understanding the objectives, nature, or consequences of the study, or who have any condition which, in the Investigator's opinion, would constitute an unacceptable risk to the subject's safety
Subjects who are currently receiving an investigational drug, have an investigational device in place, or who have participated in an investigational drug or device study within 180 days prior to Baseline. Participation in an observational study within 180 days prior to Baseline does not disqualify a subject from enrolling
Subjects who have received a prostacyclin-class therapy within 28 days of Baseline
Subjects who have a Registry to Evaluate Early and Long-Term PAH Disease Management (REVEAL) 2.0 Risk Score of 10 or greater
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