Study Stopped
Following the failure to demonstrate efficacy in EIG-UBX-001, the sponsor decided to terminate Study EIG-UBX-002.
Open-Label Extension Study of Ubenimex in Patients With Pulmonary Arterial Hypertension (WHO Group 1)
LIBERTY2
A Phase 2, Open-Label, Extension Study to Evaluate the Long-Term Safety and Efficacy of Ubenimex in Patients With Pulmonary Arterial Hypertension (WHO Group 1)
1 other identifier
interventional
51
2 countries
28
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Dec 2016
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 4, 2016
CompletedFirst Posted
Study publicly available on registry
April 13, 2016
CompletedStudy Start
First participant enrolled
December 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2018
CompletedResults Posted
Study results publicly available
January 18, 2023
CompletedJanuary 18, 2023
December 1, 2022
1.2 years
April 4, 2016
November 3, 2022
December 21, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Treatment-emergent Adverse Events (TEAEs)
Number of Patients with TEAEs collected for all patients and recorded on the Adverse Event Case Report Form
At least 24 weeks of open-label treatment with ubenimex followed by 4 weeks follow-up
Study Arms (1)
ubenimex
EXPERIMENTALubenimex 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.
Interventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
California Heart Center Foundation, An Affiliate of Cedars-Sinai Heart Institute, Cedars-Sinai Medical Care Foundation
Beverly Hills, California, 90211, United States
UCSD Medical Center
La Jolla, California, 92103, United States
Stanford University Medical Center
Palo Alto, California, 94305, United States
Harbor - UCLA Medical Center
Torrance, California, 90502, United States
University of Colorado Denver
Aurora, Colorado, 80045, United States
Cleveland Clinic, Florida
Weston, Florida, 33331, United States
Kentuckiana Pulmonary Associates
Louisville, Kentucky, 40202, United States
Chest Medicine Associates
South Portland, Maine, 04106, United States
Johns Hopkins University, Pulmonary and Critical Care Medicine
Baltimore, Maryland, 21205, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Boston University School of Medicine
Boston, Massachusetts, 02118, United States
University of Michigan
Ann Arbor, Michigan, 48103, United States
Mayo Clinic College of Medicine
Rochester, Minnesota, 55905, United States
Washington University
St Louis, Missouri, 63130, United States
Weill Cornell Medicine
New York, New York, 10065, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Cleveland Clinic Respiratory Institute
Cleveland, Ohio, 44195, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
University of Pennsylvania Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Alpert Medical School of Brown University Rhode Island Hospital
Providence, Rhode Island, 02903, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
UT Southwestern Medical Center
Dallas, Texas, 75390, United States
Houston Methodist Hospital
Houston, Texas, 77030, United States
University Texas Health Science Center
San Antonio, Texas, 78229, United States
London Health Sciences Centre
London, Ontario, N6A 5W9, Canada
University of Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7, Canada
Related Publications (2)
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.
PMID: 23986401BACKGROUNDQian 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.
PMID: 26558820BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior VP, Clinical Development
- Organization
- Eiger BioPharmaceuticals, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 4, 2016
First Posted
April 13, 2016
Study Start
December 1, 2016
Primary Completion
March 1, 2018
Study Completion
August 1, 2018
Last Updated
January 18, 2023
Results First Posted
January 18, 2023
Record last verified: 2022-12