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

Pulmonary Arterial Hypertension Clinical Trial

— LIBERTY2  

Official title:

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02736149
• Other study ID #: EIG-UBX-002
• Status: Terminated
• Phase: Phase 2
• Start date: December 2016
• Est. completion date: August 2018

Study information

• Verified date: December 2022
• Source: Eiger BioPharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This study is a Phase 2, open-label, multicenter, extension study to evaluate long-term safety and efficacy of ubenimex in patients with PAH (WHO Group 1) who complete Study EIG-UBX-001 (Study EIG-UBX-001 is a Phase 2, randomized, double-blind, placebo-controlled clinical trial) and meet the eligibility criteria for Study EIG-UBX-002. The primary objective for this study is:

• to obtain long-term safety and tolerability data for ubenimex (150 mg administered three times daily [TID]) in patients with PAH (WHO Group 1).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 51
• Est. completion date: August 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

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.

Related Conditions & MeSH terms

• Familial Primary Pulmonary Hypertension
• Hypertension
• Pulmonary Arterial Hypertension

Intervention

Drug:
• ubenimex

Locations

Country	Name	City	State
Canada	London Health Sciences Centre	London	Ontario
Canada	University of Ottawa Heart Institute	Ottawa	Ontario
United States	University of Michigan	Ann Arbor	Michigan
United States	University of Colorado Denver	Aurora	Colorado
United States	Johns Hopkins University, Pulmonary and Critical Care Medicine	Baltimore	Maryland
United States	California Heart Center Foundation, An Affiliate of Cedars-Sinai Heart Institute, Cedars-Sinai Medical Care Foundation	Beverly Hills	California
United States	Boston University School of Medicine	Boston	Massachusetts
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Tufts Medical Center	Boston	Massachusetts
United States	Cleveland Clinic Respiratory Institute	Cleveland	Ohio
United States	UT Southwestern Medical Center	Dallas	Texas
United States	Duke University Medical Center	Durham	North Carolina
United States	Houston Methodist Hospital	Houston	Texas
United States	UCSD Medical Center	La Jolla	California
United States	Kentuckiana Pulmonary Associates	Louisville	Kentucky
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Weill Cornell Medicine	New York	New York
United States	Stanford University Medical Center	Palo Alto	California
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	Mayo Clinic College of Medicine	Rochester	Minnesota
United States	Washington University	Saint Louis	Missouri
United States	University Texas Health Science Center	San Antonio	Texas
United States	Chest Medicine Associates	South Portland	Maine
United States	Harbor - UCLA Medical Center	Torrance	California
United States	Cleveland Clinic, Florida	Weston	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Eiger BioPharmaceuticals

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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