Open-Label Extension Study of Ubenimex in Patients With Pulmonary Arterial Hypertension (WHO Group 1)
NCT ID: NCT02736149
Last Updated: 2023-01-18
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
51 participants
INTERVENTIONAL
2016-12-31
2018-08-31
Brief Summary
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This study is a Phase 2, open-label, extension study to evaluate long-term safety and efficacy of ubenimex in patients with PAH (WHO Group 1) who complete Study EIG-UBX-001.
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Detailed Description
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\- to obtain long-term safety and tolerability data for ubenimex (150 mg administered three times daily \[TID\]) in patients with PAH (WHO Group 1).
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ubenimex
ubenimex capsules 150 mg three times a day (TID), administered orally, minimum of 24 weeks for all patients.
The maximum anticipated time an individual patient will participate will vary because treatment will continue until the last patient enrolled has received at least 24 weeks of open-label treatment.
ubenimex
Interventions
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ubenimex
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* In the opinion of the Principal Investigator, has been generally compliant with study requirements during Study EIG-UBX-001.
* Agrees to use a medically acceptable method of contraception throughout the entire study period.
* Willing and able to comply with scheduled visits, treatment plans, and laboratory tests and other study procedures.
Exclusion Criteria
* Concurrent regular use of another leukotriene pathway inhibitor.
* Any reason that, in the opinion of the investigator, precludes the patient from participating in the study.
1. Any condition that is unstable or that could jeopardize the safety of the patient and his/her compliance in the study
2. A serious uncontrolled medical disorder/condition that in the opinion of the investigator would impair the ability of the patient to receive protocol therapy
* An ongoing, drug-related, serious adverse event (SAE).
* Significant/chronic renal insufficiency.
* Transaminases (alanine transaminase, aspartate transaminase) levels \>3 × upper limit of normal (ULN) and/or bilirubin level \>2 × ULN.
* Absolute neutrophil count \<1500 mm3.
* Hemoglobin concentration \<9 g/dL at Screening.
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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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
Palo Alto, California, United States
Harbor - UCLA Medical Center
Torrance, California, United States
University of Colorado Denver
Aurora, Colorado, 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
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
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-002
Identifier Type: -
Identifier Source: org_study_id
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