Open-Label Extension Study of Ubenimex in Patients With Pulmonary Arterial Hypertension (WHO Group 1)

Stopped early · Phase 2

Conditions studied: Pulmonary Arterial Hypertension

In brief

Ubenimex is being developed for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization \[WHO\] Group 1) to improve exercise capacity and delay clinical worsening. 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.

Key facts

Study ID

NCT02736149

Run by

Eiger BioPharmaceuticals

People needed

51

Starts

2016-12-01

Expected to finish

2018-08-01

Last updated by the study team

2023-01-18

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must have completed Study EIG-UBX-001 through Week 24.
• 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.

You may not qualify if…

• Is pregnant or lactating.
• 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.
• Any condition that is unstable or that could jeopardize the safety of the patient and his/her compliance in the study
• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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