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99 Study Matches

Open-label, Clinical Study to Evaluate the Safety and Tolerability of TreT in Subjects With PAH Currently Using Tyvaso (BREEZE)

This is a Phase 1b safety and tolerability single-sequence study in which PAH subjects on a stable regimen of Tyvaso will switch to a corresponding dose of TreT.
Call 214-648-5005
studyfinder@utsouthwestern.edu
Trushil Shah
169968
All
18 Years and over
Phase 1
This study is NOT accepting healthy volunteers
NCT03950739
STU-2019-1262
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Inclusion Criteria:
1. Subject voluntarily gives informed consent to participate in the study. 2. Subject is aged 18 years or older at the time of signing informed consent. 3. Women of childbearing potential are those who have experienced menarche and who have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or are not postmenopausal (defined as amenorrhea for at least 12 consecutive months). WOCBP must be nonpregnant (as confirmed by a urine pregnancy test at Screening prior to initiating study medication), nonlactating, and will do 1 of the following: 1. Abstain from intercourse (when it is in line with their preferred and usual lifestyle), or 2. Use 2 medically acceptable, highly effective forms of contraception for the duration of study, and at least 30 days after discontinuing TreT. Medically acceptable, highly effective forms of contraception can include approved hormonal contraceptives (oral, injectable, and implantable), intrauterine devices or systems, and barrier methods (such as a condom or diaphragm) when used with a spermicide. 4. Males with a partner of childbearing potential must use a condom for the duration of treatment and for at least 48 hours after discontinuing TreT. 5. Subject is diagnosed with PAH as defined by the following World Health Organization (WHO) Group 1 categories: 1. Idiopathic/familial 2. Associated with unrepaired or repaired congenital systemic-to-pulmonary shunts (repaired ≥5 years prior to screening) 3. Associated with collagen vascular disease 4. Associated with human immunodeficiency virus 5. Associated with appetite suppressant/other drug or toxin use 6. Subject must have started Tyvaso ≥3 months prior to the Baseline Visit and must currently be on a stable regimen (no change in dose within 30 days of Baseline Visit) of Tyvaso (6 to 12 breaths QID). 7. Baseline 6MWD ≥150 m. 8. If currently receiving other approved background therapy (eg, endothelin receptor antagonist or phosphodiesterase type 5 inhibitor or both), the subject must be on a stable dose with no additions or discontinuations for a minimum of 30 days prior to Screening. 9. The subject has had evidence of forced expiratory volume in 1 second (FEV1) ≥60% and FEV1/forced vital capacity ratio ≥60% during the 6 months prior to enrollment. 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 all study visits.
Exclusion Criteria:
1. Subject is pregnant or lactating. 2. Subject has been diagnosed with pulmonary hypertension for reasons other than WHO Group 1 as outlined in Inclusion Criterion 5 (including but not limited to portal hypertension, chronic thromboembolic disease, pulmonary veno-occlusive disease, hemolytic anemia, sarcoidosis). 3. Subject has a history of uncontrolled sleep apnea, parenchymal lung disease, or hemodynamically significant left-sided heart disease (including but not limited to aortic or mitral valve disease, pericardial constriction, restrictive or congestive cardiomyopathy, or coronary artery disease). 4. Subject is currently taking any other prostacyclin analogue or agonist, including but not limited to selexipag, epoprostenol, iloprost, or beraprost; except for acute vasoreactivity testing. 5. Subject experienced an acute exacerbation of disease or hospitalization for any reason within 30 days of the Screening Visit or between Screening and Baseline. 6. Subject is WHO Functional Class IV at Screening. 7. Subject has used any investigational drug/device or participated in any other investigational study with therapeutic intent within 30 days prior to the Screening Visit. 8. Subject has a history of anaphylaxis, a documented hypersensitivity reaction, or a clinically significant idiosyncratic reaction to treprostinil or excipients in the investigational product. 9. Subject has conditions that, in the opinion of the Investigator, would make the subject ineligible. 10. Subject is not able to perform inhalation maneuvers that meet inspiratory training criteria. 11. Subject has a musculoskeletal disorder (eg, arthritis affecting the lower limbs, recent hip or knee joint replacement) or any disease that would likely be the primary limit to ambulation, or is connected to a machine that is not portable enough to allow for a 6MWT. 12. Subject has had a new type of chronic therapy (including but not limited to oxygen, a different class of vasodilator, diuretic, and digoxin) for pulmonary hypertension added within 30 days of the Screening Phase. 13. Initiation of pulmonary rehabilitation within 12 weeks prior to the Baseline Visit.
Drug: Treprostinil Inhalation Powder
Pulmonary Arterial Hypertension
prostacyclin
UT Southwestern
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Long-Term, Open Label Extension Study of Pemziviptadil (PB1046) in PAH Subjects Following Completion of Study PB1046-PT-CL-0004 (VIP Extend)

This is a multi-center, Phase 2 Long-Term, Open Label Extension (OLE) Study to assess the safety and tolerability of pemziviptadil (PB1046) at an optimally titrated dose. This is a Long-Term, Open label Extension (OLE) Study for subjects with (PAH), having participated in double-blind Study PB1046-PT-CL-0004. The study will include adult subjects previously diagnosed with symptomatic PAH, who are receiving background clinician-directed therapy for PAH. During this period, subjects will continue to be followed for safety and tolerability, as well as for periodic efficacy, quality of life data and immunogenicity. The study will continue per the schedule of events until such time when pemziviptadil (PB1046) is able to be self-administered, becomes commercially available to the subjects in a particular country or region, or the sponsor terminates the study due to lack of efficacy, safety or other reasons.
Call 214-648-5005
studyfinder@utsouthwestern.edu
Sonja Bartolome
115047
All
18 Years to 79 Years old
Phase 2
This study is NOT accepting healthy volunteers
NCT03795428
STU-2019-0608
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Inclusion Criteria:

• Subjects must have completed Week 17 / End of Study of PB1046-PT-CL-0004;
• Willing and able to sign a written Informed Consent (IC) prior to all study-related procedures;
• Agrees to use a medically acceptable method of contraception (both male and female patients) throughout the entire study period and continuing for 30 days after their last dose of study drug. if the possibility of conception exists. Medically acceptable methods of contraception include the following: abstinence (not having sex), vasectomy (with confirmed negative sperm counts), condoms and partner using vaginal spermicide and/or cervical cap with spermicide or sponge; oral, implantable, or injectable contraceptives (starting ˃2 months before dosing), diaphragm with vaginal spermicide, intrauterine device, surgical sterilization (˃6 months after surgery). Female subjects ˂45 years of age of non-childbearing potential are defined as being surgically sterile by bilateral tubal ligation, bilateral oophorectomy, or hysterectomy. Female subjects 45to-60 years of age, inclusive, who are post-menopausal for at least 1 year, and have a follicle-stimulating hormone (FSH) level confirmation indicating post-menopausal status, will be considered to be of non-childbearing potential. Female subjects > 60 years of age are considered post-menopausal and of non-childbearing potential;
• Willing and able to understand and follow instructions, return to the study unit for specified study visits; and, be able to participate in the study through the Stable Dose Maintenance Period, at a minimum.
Exclusion Criteria:

• Concomitant medical disorder, condition, or history, that in the opinion of the Investigator, would impair the subject's ability to participate in or complete the requirements of the study;
• Pregnant or lactating female subjects;
• Significant liver dysfunction as measured by any one of the following during participation in PB1046-PT-CL-0004. (If exclusionary laboratory results become available after the subject has enrolled in PB1046-PT-CL-0006 they should be discontinued. a. alanine aminotransferase (ALT) > 3.0 times upper limit of normal (ULN) or; b. aspartate aminotransferase (AST) > 3.0 times ULN or; c. serum bilirubin ≥ 1.6 mg/dL.
• Recent history of substance abuse that, in the opinion of the Investigator, would impair the subject's ability to participate in or complete the requirements of the study;
• In the opinion of the principal investigator (PI), any major surgical procedure within 90 days, or a planned surgical procedure during the study period; which would impact participation in PB1046-PT-CL-0006.
• Other new medical or psychiatric conditions which, in the opinion of the Investigator, would place the subject at increased risk, would preclude obtaining voluntary consent, or would confound the objectives of the study;
• Known hypersensitivity to study drug or any of the excipients of the drug formulation.
Drug: Pemziviptadil (PB1046) Injection
Pulmonary Arterial Hypertension
UT Southwestern
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RejuvenAir® System Trial for COPD With Chronic Bronchitis (SPRAY-CB)

Chronic Obstructive Pulmonary Disease (COPD) is defined as an impaired ability to move air within the lungs and is a major public health problem that is projected to rank fifth worldwide in terms of disease burden and third in terms of mortality. Chronic bronchitis (CB) is a common clinical phenotype within the umbrella of a COPD diagnosis and is classically defined as chronic cough and sputum production for 3 months a year for 2 consecutive years2, but many studies have used different definitions to define it- chronic cough and sputum production for one year or cough and sputum production on most days of the week. CB is associated with multiple clinical consequences, including; the worsening of lung function decline, increasing risk of acute exacerbations of COPD, increased risk of developing pneumonia, reduced health related quality of life, and an increase in all-cause mortality.
Call 214-648-5005
studyfinder@utsouthwestern.edu
Muhanned Abu-Hijleh
123140
All
40 Years to 80 Years old
N/A
This study is NOT accepting healthy volunteers
NCT03893370
STU-2019-0896
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Inclusion Criteria
• Males and females ≥40 to ≤80 years of age
• Subject is able to read, understand, and sign a written Informed Consent in order to participate in the Study
• Subject has a diagnosis of chronic bronchitis (CB) and chronic obstructive pulmonary disease (COPD) for a minimum of two years. (Chronic Bronchitis is defined clinically as chronic productive cough for 3 months in each of 2 successive years in a patient in whom other causes of productive cough have been excluded)
• Subject is classified as having a moderate or severe (GOLD 2/3) airflow obstruction defined by a post-bronchodilator of ≥30% FEV1 to <80% predicted with a baseline FEV1/FVC of <0.70.
• Subject has a Baseline SGRQ of ≥50.
• Subject has had either 2 moderate exacerbations or 1 severe exacerbation in the past year. (exacerbations must be documented)
• Subject demonstrates daily cough and significant mucus.
• Subject is being treated according to current medically accepted treatment guidelines for chronic bronchitis for minimum of 3 months prior to enrollment into the study. Subject agrees to continue maintenance pulmonary/COPD medications (GOLD standard medications recommended) for the duration of the study
• Smoking history of at least 10 pack years
• Non-smoking for a minimum of 2 months prior to consent and agrees to continue not smoking for the duration of the study
• Subject is able to adhere to and undergo 2 bronchoscopic procedures (cross over subjects may undergo two additional bronchoscopic procedures, if they agree to treatment), per hospital guidelines
• Subject demonstrates ability and willingness to use a daily eDiary Exclusion Criteria
• Subject has had an acute pulmonary infection, exacerbation or pneumonia requiring medical treatment (with antibiotics and/or steroids) within 4 weeks prior of initially planned study bronchoscopy
• Diagnosis of Asthma
• Subject has Alpha-1 antitrypsin deficiency
• Subject has other origins of respiratory disease aside from chronic bronchitis and COPD
• Subject is using e-cigarettes, vaping or taking any inhaled substances not prescribed by a physician
• Subject has untreatable or life threatening arrhythmias, inability to adequately oxygenate during the bronchoscopy, or has acute respiratory failure
• Subject has bullous emphysema characterized as large bullae >30 millimeters on HRCT; or subject has stenosis in the tracheobronchial system, tracheobronchomegaly, trachea-bronchomalacia, amyloidosis or cystic fibrosis
• Subject has clinically significant bronchiectasis
• Subject has had a transplant procedure (any)
• Subject has a known mucosal tear, has undergone prior lung surgery such as pneumonectomy, lobectomy, bullectomy, or lung volume reduction surgery
• Subject has had a prior lung device procedure, including emphysema stent(s) implanted, lung coils, valves, lung denervation, bronchial thermoplasty, cryotherapy or other therapies
• Subject is unable to temporarily discontinue use of anticoagulant therapy: warfarin, Coumadin, LMWH, heparin, clopidrogel (or equal)
• Subject has a serious medical condition, such as: uncontrolled coagulopathy or bleeding disorder, congestive heart failure, uncontrolled angina, myocardial infarction in the past year, renal failure, liver disease, cerebrovascular accident within the past 6 months, uncontrolled diabetes, uncontrolled hypertension, autoimmune disease or uncontrolled gastric reflux
• Subject is pregnant, nursing, or planning to get pregnant during study duration
• Subject has or is receiving chemotherapy or active radiation therapy within the past 6 months or is expected to receive chemotherapy during participation in this study
• Subject is or has been in another clinical investigational study within 6 weeks of enrollment and agrees to not participate in any other treatment studies for the duration of study participation
• Subject has known sensitivity to medication required to perform bronchoscopy (such as lidocaine, atropine, and benzodiazepines)
Device: RejuvenAir System, Device: Sham Control Procedure
Chronic Bronchitis
UT Southwestern
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Safety, Tolerability, and Pharmacokinetic Study of TRK-250 for Patients With Idiopathic Pulmonary Fibrosis

TRK-250 is a nucleic acid medicine that inhibits the progression of pulmonary fibrosis by selectively suppressing the expression of transforming growth factor-beta 1 (TGF-β1) protein, at the gene expression level. This study is a double-blind, randomized, placebo-controlled Phase I study. The primary objective of the study is to assess the safety and tolerability of single and multiple inhaled doses of TRK-250 in subjects with idiopathic pulmonary fibrosis (IPF).
Call 214-648-5005
studyfinder@utsouthwestern.edu
Craig Glazer
12613
All
40 Years to 80 Years old
Phase 1
This study is NOT accepting healthy volunteers
NCT03727802
STU-2019-1521
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Inclusion Criteria:

• Clinical, radiographic, and histologic features consistent with the diagnosis of IPF
• SpO2 ≥90% at rest by pulse oximetry while breathing ambient air.
• FVC ≥50% of predicted.
• FEV1 ≥50% of predicted.
• Ratio of FEV1 to FVC ≥0.7.
• DLCO corrected for hemoglobin 30% to 79% of predicted, inclusive.
Exclusion Criteria:

• History of acute exacerbation of IPF or respiratory tract infection within 3 months prior to Screening.
• Planned surgery during the study.
• History of malignant tumor within 5 years prior to Screening.
• History of emphysema or clinically significant respiratory diseases (other than IPF).
• Other known causes of interstitial lung disease (eg, drug toxicities, environmental exposures, connective tissue diseases).
• End-stage fibrotic disease expected to require organ transplantation within 6 months.
• Taking a systemic corticosteroid, cytotoxic therapy, vasodilator therapy for pulmonary hypertension, or unapproved treatment for IPF within 4 weeks prior to Screening. (Treatment with pirfenidone or nintedanib, though not both concurrently, is permitted, provided that the subject has been on a stable dose for at least 4 weeks prior to Screening and it is anticipated the dose will remain unchanged throughout enrollment.)
Drug: TRK-250, Drug: Placebo
Idiopathic Pulmonary Fibrosis
TRK-250, Idiopathic Pulmonary Fibrosis
UT Southwestern
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FUVID Study: Functional Characterization of Children With Chronic Venous Thromboembolic Disease

This is a multi-center prospective cohort study of patients with first-episode deep venous thrombosis and pulmonary embolism.
Call 214-648-5005
studyfinder@utsouthwestern.edu
Ayesha Zia
149180
All
8 Years to 21 Years old
This study is NOT accepting healthy volunteers
NCT04583878
STU-2020-0868
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Inclusion Criteria:

• Children with acute, radiologically confirmed pulmonary embolism (PE) with our without DVT
• Ages 8 to ≤ 21 years
• Participant must be able to speak and understand English
• Be willing to participate and able to comply with the study protocol
Exclusion Criteria:

• Prior history of DVT or PE (upper extremity, cerebral sinus venous thrombosis and abdominal thromboses encountered as a neonate are not exclusion criteria)
• Lack of anticoagulant treatment for the acute VTE due to contraindications
• Congenital heart disease with abnormal pulmonary circulation or with in-situ pulmonary artery thrombosis
• Chronic kidney disease
• Chronic inflammatory or an autoimmune disorder (such as systemic lupus erythematosus, juvenile rheumatoid disorder, inflammatory bowel disease, and sickle cell disease)
• A metabolic or endocrinological disorder such as diabetes mellitus or thyroid disorder
• Cancer-associated VTE
• Pregnant
• Musculoskeletal limitations to exercise expected to be present uptil 4 months post-diagnosis
• Weight ≥ 300 lbs
• Contraindications to magnetic resonance imaging
• Frequent severe exacerbations of asthma defined by two or more bursts of systemic glucocorticoids (more than three days each) in the previous year or at least one hospitalization, intensive care unit stay or mechanical ventilation in the previous year. Patients should also be excluded if there are daily symptoms of asthma requiring daily use of short-acting bronchodilators such as albuterol or levalbuterol administration. The use of controller medications such as daily inhaled corticosteroids for mild persistent asthma is not exclusionary.
• Has any other medical condition, which in the opinion of the investigator may potentially compromise the safety or compliance of the patient or may preclude the patient's successful completion of the clinical study
Pulmonary Embolism, Deep Venous Thrombosis, Cardiovascular, Lung/Thoracic
UT Southwestern; Parkland Health & Hospital System
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Diaphragmatic Hernia Research & Exploration, Advancing Molecular Science (DHREAMS)

The goal of this study is to identify genes that convey susceptibility to congenital diaphragmatic hernia in humans. The identification of such genes, and examination of their structure and function, will enable a delineation of molecular pathogenesis and, ultimately, prevention or treatment of congenital diaphragmatic hernia. There are many different possible modes of inheritance for congenital anomalies, including autosomal dominant, autosomal recessive, and multifactorial. Multi-factorial inheritance is responsible for many common medical disorders, including hypertension, myocardial infarction, diabetes and cancer. This type of inheritance pattern appears to involve environmental factors as well as a combination of genetic variations that together can predispose to or produce congenital anomalies, such as congenital diaphragmatic hernia. Our study is designed to establish a small, well-defined genetic resource consisting of 1) Nuclear families suitable for linkage analysis by parametric,non-parametric (e.g. sib pairs, TDT) and association techniques, 2) Individuals with congenital diaphragmatic hernia who can be directly screened for allelic variation in candidate genes, and 3) Individuals who can serve as controls (are unaffected by congenital diaphragmatic hernia). Neonates and their families will be collected from homogenous and heterogeneous populations. By characterizing diverse populations, it should be possible to increase the likelihood of demonstration of genetic variation in selected candidate genes that can then be used in association and linkage studies in individual subjects with congenital diaphragmatic hernia.
Call 214-648-5005
studyfinder@utsouthwestern.edu
David Schindel
69697
All
Not specified
N/A
This study is also accepting healthy volunteers
NCT00950118
STU 102014-040
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Inclusion Criteria:

• All individuals affected with a congenital diaphragmatic hernia (CDH), or with a family history of a CDH
Exclusion Criteria:

• Individuals with no personal history of a CDH or family history of a family member affected with congenital diaphragmatic hernia
Congenital Diaphragmatic Hernia
Congenital Diaphragmatic Hernia (CDH), Genes, Genetic, Genetic testing, exome sequencing, genome sequencing, RNAseq
UT Southwestern; Children’s Health; Parkland Health & Hospital System
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A Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label Extension

Study ROR-PH-303, ADVANCE EXTENSION, is an open-label extension (OLE) study for participants with WHO Group 1 PAH who have participated in another Phase 2 or Phase 3 study of ralinepag.
Call 214-648-5005
studyfinder@utsouthwestern.edu
Sonja Bartolome
115047
All
18 Years to 75 Years old
Phase 3
This study is NOT accepting healthy volunteers
NCT03683186
STU-2018-0148
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Inclusion Criteria:
1. Evidence of a personally signed and dated informed consent form indicating that the subject has been informed of all pertinent aspects of the study prior to initiation of any study-related procedures. 2. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. 3. Completed the protocol-defined Study Drug Termination Visit or End of Study Visit procedures in the preceding ralinepag study. 4. Both male and female subjects agree to use a medically acceptable method of contraception throughout the entire study period from informed consent through the 30 day Follow-up Visit, if the possibility of conception exists. Eligible male and female subjects must also agree not to participate in a conception process (i.e., actively attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization) during the study and for 30 days after the last dose of ralinepag.
Exclusion Criteria:
1. Subjects who prematurely discontinued investigational medicinal product (IMP) due to a drug-related AE/SAE or tolerability issue in the preceding ralinepag study in which they were enrolled, or subjects who did not complete all protocol defined study procedures at a Study Drug Termination Visit or End of Study Visit in the preceding ralinepag study. 2. Subjects who withdrew consent during participation in another ralinepag study. 3. Female subjects who wish to become pregnant or who have a positive pregnancy test on Day 1 (OLE Entry Visit), or are lactating or breastfeeding. 4. Subjects who have undergone lung or heart/lung transplant or the initiation of long-term parenteral or inhaled therapy with a prostacyclin during the time since participation in their original ralinepag study. 5. Subjects who had an emergency unblinding procedure in a prior Phase 2 or 3 study.
Drug: Ralinepag
Pulmonary Hypertension, Pulmonary Arterial Hypertension, Hypertension, Cardiovascular Diseases, Hypertension, Pulmonary, PAH, Connective Tissue Diseases, Familial Primary Pulmonary Hypertension, Vascular Diseases, Lung Diseases, Respiratory Tract Disease
Prostacyclin, Connective Tissue Disease-Associated, 6 Minute Walk Test, 6 Minute Walk Distance, Pulmonary Vascular Resistance, Right Ventricular Function
UT Southwestern
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Predictors of Severe COVID-19 Outcomes (PRESCO)

This is a longitudinal, multi-center, observational study collecting diverse biological measurements and clinical and epidemiological data for the purpose of enabling a greater understanding of the onset of severe outcomes, primarily acute respiratory distress syndrome (ARDS) and/or mortality, in patients presenting to the hospital with suspicion or diagnosis of COVID-19. We seek to understand whether there are early signatures that predict progression to ARDS, mortality, and/or other comorbid conditions. The duration of the study participation is approximately 3 months.
Call 214-648-5005
studyfinder@utsouthwestern.edu
Mujeeb Basit
28504
All
18 Years and over
This study is NOT accepting healthy volunteers
NCT04388813
STU-2020-0762
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Inclusion Criteria:

• Participant or legally authorized representative willing and able to provide informed consent
• Receiving care at a participating site
• Age 18 years old or older
• U.S. Resident
• Confirmed positive for COVID-19
• Willing and able to comply with all study procedures
Exclusion Criteria:

• Self reported pregnancy
Acute Respiratory Distress Syndrome, COVID-19
UT Southwestern
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Long-Term Extension Study of Inhaled Nitric Oxide (iNO) for PAH

An Open-Label Long-Term Safety Study of Inhaled Nitric Oxide (iNO) for Pulmonary Arterial Hypertension (PAH)
Call 214-648-5005
studyfinder@utsouthwestern.edu
Fernando Torres
45956
All
Not specified
Phase 3
This study is NOT accepting healthy volunteers
NCT02652429
STU-2019-1267
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Inclusion Criteria:

• Signed Informed Consent Form prior to the initiation of any study mandated procedures or assessments.
• PAH subjects who have completed all EOS assessments in IK-7001-PAH-201 and PULSE-PAH-004 and have continued drug/device usage.
• Subjects are willing and considered in the judgement of the Investigator able to use the INOpulse device continuously for up to 24 hours per day.
• All female subjects must be willing to continue to take adequate precaution to avoid pregnancy.
• Subjects in need for continued treatment with iNO in the opinion of the treating physician and agreement from Sponsor.
Exclusion Criteria:

• Subjects who require treatment with riociguat
• Subjects who early discontinued drug/device usage due to withdrawal of consent or an AE requiring termination from treatment in IK-7001-PAH-201
Drug: Inhaled Nitric Oxide
Pulmonary Arterial Hypertension
PAH, Pulmonary Arterial Hypertension, Inhaled Nitric Oxide, iNO
UT Southwestern
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