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Open-Label Extension Study of Ubenimex in Patients With Pulmonary Arterial Hypertension (WHO Group 1) (LIBERTY2)

Primary Purpose

Pulmonary Arterial Hypertension

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ubenimex
Sponsored by
Eiger BioPharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Arterial Hypertension

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • California Heart Center Foundation, An Affiliate of Cedars-Sinai Heart Institute, Cedars-Sinai Medical Care Foundation
  • UCSD Medical Center
  • Stanford University Medical Center
  • Harbor - UCLA Medical Center
  • University of Colorado Denver
  • Cleveland Clinic, Florida
  • Kentuckiana Pulmonary Associates
  • Chest Medicine Associates
  • Johns Hopkins University, Pulmonary and Critical Care Medicine
  • Tufts Medical Center
  • Brigham and Women's Hospital
  • Boston University School of Medicine
  • University of Michigan
  • Mayo Clinic College of Medicine
  • Washington University
  • Weill Cornell Medicine
  • Duke University Medical Center
  • Cleveland Clinic Respiratory Institute
  • University of Pennsylvania
  • Allegheny General Hospital
  • University of Pennsylvania Medical Center
  • Alpert Medical School of Brown University Rhode Island Hospital
  • Vanderbilt University Medical Center
  • UT Southwestern Medical Center
  • Houston Methodist Hospital
  • University Texas Health Science Center
  • London Health Sciences Centre
  • University of Ottawa Heart Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ubenimex

Arm Description

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.

Outcomes

Primary Outcome Measures

Treatment-emergent Adverse Events (TEAEs)
Number of Patients with TEAEs collected for all patients and recorded on the Adverse Event Case Report Form

Secondary Outcome Measures

Full Information

First Posted
April 4, 2016
Last Updated
December 21, 2022
Sponsor
Eiger BioPharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT02736149
Brief Title
Open-Label Extension Study of Ubenimex in Patients With Pulmonary Arterial Hypertension (WHO Group 1)
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Terminated
Why Stopped
Following the failure to demonstrate efficacy in EIG-UBX-001, the sponsor decided to terminate Study EIG-UBX-002.
Study Start Date
December 2016 (undefined)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
August 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eiger BioPharmaceuticals

4. Oversight

5. Study Description

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.
Detailed 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Arterial Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ubenimex
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
ubenimex
Other Intervention Name(s)
UBX
Primary Outcome Measure Information:
Title
Treatment-emergent Adverse Events (TEAEs)
Description
Number of Patients with TEAEs collected for all patients and recorded on the Adverse Event Case Report Form
Time Frame
At least 24 weeks of open-label treatment with ubenimex followed by 4 weeks follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. 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.
Facility Information:
Facility Name
California Heart Center Foundation, An Affiliate of Cedars-Sinai Heart Institute, Cedars-Sinai Medical Care Foundation
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
UCSD Medical Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Stanford University Medical Center
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Harbor - UCLA Medical Center
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
University of Colorado Denver
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Cleveland Clinic, Florida
City
Weston
State/Province
Florida
ZIP/Postal Code
33331
Country
United States
Facility Name
Kentuckiana Pulmonary Associates
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Chest Medicine Associates
City
South Portland
State/Province
Maine
ZIP/Postal Code
04106
Country
United States
Facility Name
Johns Hopkins University, Pulmonary and Critical Care Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Boston University School of Medicine
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48103
Country
United States
Facility Name
Mayo Clinic College of Medicine
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63130
Country
United States
Facility Name
Weill Cornell Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Cleveland Clinic Respiratory Institute
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
University of Pennsylvania Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Alpert Medical School of Brown University Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Houston Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University Texas Health Science Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Facility Name
University of Ottawa Heart Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4W7
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
23986401
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.
Results Reference
background
PubMed Identifier
26558820
Citation
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.
Results Reference
background

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

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