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Active Clinical Trials

UT 201

Active NCT:
02630316
Allegheny General Hospital
Allegheny General Hospital

Sponsor: 
United Therapeutics
Contact: 

For more information, please contact Joan Rossi at 412-359-3293 or Joan.Rossi@ahn.org

RIN-PH-201: A Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Safety and Efficacy of Inhaled Treprostinil in Subjects with Pulmonary Hypertension due to Parenchymal Lung Disease

Purpose: 

This is a multicenter, randomized (1:1 inhaled treprostinil: placebo), double-blinded, placebo-controlled 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 314 patients at approximately 100 clinical trial centers. The treatment phase of the study will last approximately 16 weeks. Patients who complete all required assessments will also be eligible to enter an open-label, extension study (RIN-PH-202).

Ages Eligible for Study: 18 Years to 79 Years (Adult, Senior)
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:

  1. Subject voluntarily gives informed consent to participate in the study.
  2. Males and females aged 18 - 79 years at the time of informed consent. a. Females of reproductive potential must be non-pregnant (as confirmed by a urine pregnancy test at screening) and non-lactating, and will: i. Either abstain from intercourse (when it is in line with their preferred and usual lifestyle), or ii. Use two medically acceptable, highly-effective forms of contraception for the duration of study, and at least 30 days after discontinuing study drug. b. Males must use a condom for the duration of treatment and for at least 48 hours after discontinuing study drug.
  3. The subject has a confirmed diagnosis (based on computed tomography [CT] imaging and pulmonary function tests [PFTs] performed within six months prior to randomization) of World Health Organization (WHO) Group 3 PH associated with one of the following: a. Idiopathic interstitial pneumonia (IIP) including: i. Idiopathic pulmonary fibrosis (IPF) ii. Idiopathic nonspecific interstitial pneumonia iii. Respiratory bronchiolitis-associated interstitial lung disease (RB-ILD) iv. Desquamative interstitial pneumonia (DIP) v. Cryptogenic organizing pneumonia (COP) vi. Acute interstitial pneumonitis (AIP) vii. Idiopathic lymphoid interstitial pneumonia viii. Idiopathic pleuroparenchymal fibroelastosis iix. Unclassifiable idiopathic interstitial pneumonia b. Chronic hypersensitivity pneumonitis (CHP) c. Occupational or environmental lung disease (drug or radiation-induced) d. Combined pulmonary fibrosis and emphysema (CPFE)
  4. Subjects are required to have a right heart catheterization (RHC) within one year prior to randomization with the following documented parameters:
    1. Pulmonary vascular resistance (PVR) ≥ 4 Wood Units (WU) and
    2. A left ventricular end diastolic pressure (LVEDP) or pulmonary capillary wedge pressure (PCWP) of ≤ 12 mmHg if PVR ≥ 4 WU to < 6.25 WU or ≤ 15 mmHg if PVR ≥ 6.25 WU and
    3. A mean pulmonary arterial pressure (mPAP) of ≥ 30 mmHg
  5. A baseline diffusing capacity of the lungs for carbon monoxide (DLCO) of < 50%
  6. Baseline 6MWD ≥ 100 meters
  7. The subject has not received any PAH approved therapy including: prostacyclin therapy (i.e., epoprostenol, treprostinil, iloprost, or beraprost; except for acute vasoreactivity testing), IP receptor agonist (selexipag), endothelin receptor antagonist (ERA), phosphodiesterase type 5 inhibitor (PDE-5I), or soluble guanylate cyclase stimulator (sGC) within 60 days of randomization.
  8. Subjects on a chronic medication for underlying lung disease must be on a stable and optimized dose for ≥ 30 days prior to randomization. Subjects receiving pirfenidone or nintedanib must have been receiving treatment for at least 90 days and on a stable dose for at least 30 days prior to randomization.
  9. Subjects on a supportive medication therapy (e.g., anticoagulants, diuretics, oxygen, etc.) must be on a stable and optimized dose for ≥ 30 days prior to randomization. Exceptions are the discontinuation or dose changes of anticoagulants and / or dose change of diuretics.
  10. In the opinion of the Investigator, the subject is able to communicate effectively with study personnel, and is considered reliable, willing and likely to be cooperative with protocol requirements, including attending all study visits.

 

Exclusion criteria:

  1. The subject has a diagnosis of pulmonary arterial hypertension (PAH) or PH for reasons other than ILD as outlined in inclusion criterion 3. This would include, but is not limited to, the concomitant presence of thromboembolic disease (acute or chronic), untreated or inadequately treated obstructive sleep apnea (OSA), connective tissue disease (including but not limited to systemic sclerosis, scleroderma, or systemic lupus erythematosus [SLE]), sarcoidosis, human immunodeficiency virus (HIV)-1 infection, portopulmonary hypertension, and other conditions of the WHO Group I, II, IV, and V classification.
  2. The subject has shown intolerance or significant lack of efficacy to a prostacyclin or prostacyclin analogue that resulted in discontinuation or inability to effectively titrate that therapy.
  3. The subject has received any PAH approved therapy including: prostacyclin therapy (i.e., epoprostenol, treprostinil, iloprost, or beraprost; except for acute vasoreactivity testing), IP receptor agonist (selexipag), ERA, PDE-5I, or sGC within 60 days of randomization.
  4. The subject has evidence of clinically significant left-sided heart disease as defined by:
    1. LVEDP or PCWP > 15 mmHg (or > 12 mmHg if PVR ≥4 to < 6.25 WU)
    2. Left ventricular ejection fraction < 40% as assessed by either multigated angiogram (MUGA), angiography or echocardiography.
  5. Note: Subjects with abnormal left ventricular function attributable entirely to impaired left ventricular filling due to the effects of right ventricular overload (i.e., right ventricular hypertrophy and/or dilatation) will not be excluded.
  6. Subjects must not have three or more of the following left ventricular disease/dysfunction risk factors:
    1. Body Mass Index (BMI) ≥ 30 kg/m2
    2. History of Essential Hypertension
    3. Diabetes Mellitus - any type
    4. Historical evidence of significant coronary disease established by any one of the following:
  7. i. history of myocardial infarction or percutaneous coronary intervention or angiographic, or ii. evidence of coronary artery disease (> 50% stenosis in at least one coronary artery), or iii. positive stress test with imaging, or previous coronary artery bypass graft, or stable angina
  8. The subject is receiving > 10 L/min of oxygen supplementation by any mode of delivery at rest at Baseline.
  9. Use of any inhaled tobacco/marijuana products or significant history of drug abuse within six months prior to randomization.
  10. Exacerbation of underlying lung disease or active pulmonary or upper respiratory infection within 30 days of randomization.
  11. Initiation of pulmonary rehabilitation within 12 weeks prior to the randomization.
  12. The subject has uncontrolled systemic hypertension as evidenced by systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg.
  13. The subject has any form of congenital heart disease or congenital heart defect (repaired or unrepaired) other than a patent foramen ovale (PFO).
  14. The subject has anemia as defined by a screening hemoglobin value < 9.0 g/dL, active infection, or any other condition that would interfere with the interpretation of study assessments.
  15. The subject has a Body Mass Index ≥ 40 kg/m2.
  16. The subject has any musculoskeletal disorder (i.e., arthritis affecting the lower limbs, recent hip or knee joint replacement, artificial leg), is using a device to assist walking (i.e., cane or walker), or has any other condition that would limit ambulation.
  17. Use of any investigational drug/device, or participation in any investigational study within 30 days prior to randomization.