A Study of Ubenimex in Patients With Pulmonary Arterial Hypertension (WHO Group 1)
NCT ID: NCT02664558
Last Updated: 2023-03-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
61 participants
INTERVENTIONAL
2016-04-30
2018-01-31
Brief Summary
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Detailed Description
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* To evaluate the efficacy of ubenimex in patients with PAH (WHO Group 1).
* To evaluate the safety and tolerability of ubenimex in patients with WHO Group 1 PAH.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ubenimex
ubenimex capsules 150 mg three times a day (TID), administered orally for a total of 24 weeks.
ubenimex
placebo
placebo capsules TID, administered orally for a total of 24 weeks
placebo
Interventions
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ubenimex
placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Has a diagnosis of WHO Group 1 PAH.
3. Right heart catheterization performed at Screening with results that are:
1. Mean pulmonary arterial pressure ≥25 mmHg (at rest) and
2. Pulmonary venous hypertension (measured as pulmonary capillary wedge pressure (PCWP) ≤15 mmHg. If PCWP is not available, then mean left atrial pressure or left ventricular end-diastolic pressure ≤15 mmHg in the absence of left atrial obstruction. and
3. Pulmonary vascular resistance (PVR) ≥300 dyn•s/cm5 (3.75 Wood units)
4. Has WHO/NYHA-FC of II or III.
5. Be on stable dose of at least one of the following PAH-specific therapies: endothelin receptor antagonist, an agent acting on the nitric oxide pathway (phosphodiesterase type 5 inhibitor or soluble guanylate cyclase stimulator), and/or a prostacyclin or prostacyclin analog.
6. Has a 6-minute walk distance that is ≥150 and ≤500 meters.
7. Have a ventilation-perfusion scan that rules out thromboembolic disease.
Exclusion Criteria
1. History of uncontrolled hypertension
2. Persistent hypotension at Screening.
3. Evidence or history of left-sided heart disease and/or clinically significant cardiac disease in which pulmonary hypertension is more likely WHO Group 2.
4. Acute decompensated heart failure within 1 month of Screening.
5. Recent initiation (\<8 weeks from Screening) or planned initiation of cardiopulmonary rehabilitation exercise program.
Exclusions Related to Pulmonary Disease
6. Newly diagnosed with PAH and not on PAH-specific therapy.
7. Pulmonary hypertension due to:
1. Uncorrected congenital systemic-to-pulmonary shunt.
2. Pulmonary veno-occlusive disease and/or pulmonary capillary hemangiomatosis
3. Persistent pulmonary hypertension of the newborn
4. WHO clinical classification Groups 2-5
8. Evidence of significant airway and/or parenchymal lung disease.
9. Chronic infection related to tuberculosis or fungal or mycobacterial disease.
Exclusions Based on Other Medical Conditions
10. Chronic infections including, but not limited to tuberculosis (TB), hepatitis B virus (HBV) or hepatitis C virus (HCV).
11. History of portal hypertension or chronic liver disease, including positive serology for infection with HCV and/or HBV.
12. Evidence of active infection requiring intravenous or oral antibiotics within 4 weeks of Screening.
13. Body mass index ≥35.0 at Screening.
14. History of obstructive sleep apnea.
15. History of malignancy within the last 5 years, except nonmelanoma skin cancer and cervical carcinoma in situ treated with curative intent.
16. Neuropsychiatric disorders/symptoms or psychological conditions.
17. Pregnancy or breast-feeding
18. Prior treatment with B cell or lymphocyte-depleting agents (eg, rituximab, Campath)
Exclusions Based on Concomitant Medication Use
19. Concurrent regular use of another leukotriene pathway inhibitor, including over-the-counter medications or herbal remedies.
Exclusions Based on Laboratory Values
20. Significant/chronic renal insufficiency.
21. Transaminases (alanine transaminase, aspartate transaminase) levels \>3 × upper limit of normal (ULN) and/or bilirubin level \>2 × ULN.
22. Absolute neutrophil count \<1500 mm3.
23. Hemoglobin concentration \<9 g/dL at Screening.
24. Hepatic dysfunction as defined by Child-Pugh Class B or C
18 Years
75 Years
ALL
No
Sponsors
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Eiger BioPharmaceuticals
INDUSTRY
Responsible Party
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Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
California Heart Center Foundation, An Affiliate of Cedars-Sinai Heart Institute, Cedars-Sinai Medical Care Foundation
Beverly Hills, California, United States
UCSD Medical Center
La Jolla, California, United States
Stanford University Medical Center
Stanford, California, United States
University of Colorado Denver
Aurora, Colorado, United States
University of Florida
Gainesville, Florida, United States
Cleveland Clinic, Florida
Weston, Florida, United States
Kentuckiana Pulmonary Associates
Louisville, Kentucky, United States
Chest Medicine Associates
South Portland, Maine, United States
Johns Hopkins University, Pulmonary and Critical Care Medicine
Baltimore, Maryland, United States
Tufts Medical Center
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Boston University School of Medicine
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Mayo Clinic College of Medicine
Rochester, Minnesota, United States
Washington University
St Louis, Missouri, United States
Weill Cornell Medicine
New York, New York, United States
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Cleveland Clinic Respiratory Institute
Cleveland, Ohio, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
University of Pennsylvania Medical Center
Pittsburgh, Pennsylvania, United States
Alpert Medical School of Brown University Rhode Island Hospital
Providence, Rhode Island, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States
University Texas Health Science Center
San Antonio, Texas, United States
London Health Sciences Centre
London, Ontario, Canada
University of Ottawa Heart Institute
Ottawa, Ontario, Canada
Toronto General Hospital
Toronto, Ontario, Canada
Countries
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References
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Tian W, Jiang X, Tamosiuniene R, Sung YK, Qian J, Dhillon G, Gera L, Farkas L, Rabinovitch M, Zamanian RT, Inayathullah M, Fridlib M, Rajadas J, Peters-Golden M, Voelkel NF, Nicolls MR. Blocking macrophage leukotriene b4 prevents endothelial injury and reverses pulmonary hypertension. Sci Transl Med. 2013 Aug 28;5(200):200ra117. doi: 10.1126/scitranslmed.3006674.
Qian J, Tian W, Jiang X, Tamosiuniene R, Sung YK, Shuffle EM, Tu AB, Valenzuela A, Jiang S, Zamanian RT, Fiorentino DF, Voelkel NF, Peters-Golden M, Stenmark KR, Chung L, Rabinovitch M, Nicolls MR. Leukotriene B4 Activates Pulmonary Artery Adventitial Fibroblasts in Pulmonary Hypertension. Hypertension. 2015 Dec;66(6):1227-1239. doi: 10.1161/HYPERTENSIONAHA.115.06370. Epub 2015 Oct 5.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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EIG-UBX-001
Identifier Type: -
Identifier Source: org_study_id
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