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

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ClinicalTrials.gov Identifier: NCT02736149
Recruitment Status : Terminated (Following the failure to demonstrate efficacy in EIG-UBX-001, the sponsor decided to terminate Study EIG-UBX-002.)
First Posted : April 13, 2016
Last Update Posted : July 18, 2019
Sponsor:
Information provided by (Responsible Party):
Eiger BioPharmaceuticals

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, 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).


Condition or disease Intervention/treatment Phase
Pulmonary Arterial Hypertension Drug: ubenimex Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : December 2016
Actual Primary Completion Date : March 2018
Actual Study Completion Date : August 2018


Arm Intervention/treatment
Experimental: 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.

Drug: ubenimex



Primary Outcome Measures :
  1. Treatment-emergent adverse events recorded on the Adverse Event Case Report Form [ Time Frame: through study completion, an average of 1 year ]

Secondary Outcome Measures :
  1. Change in pulmonary vascular resistance (PVR) [ Time Frame: through study completion, an average of 1 year ]
  2. Change in exercise capacity as measured by 6-minute walk distance (6MWD) [ Time Frame: through study completion, an average of 1 year ]
  3. Change in World Health Organization/New York Heart Association Functional Classification [ Time Frame: through study completion, an average of 1 year ]
  4. Change in disease biomarkers brain natriuretic peptide (BNP) /N-terminal pro-brain natriuretic peptide (NT-proBNP ) [ Time Frame: through study completion, an average of 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

    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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02736149


  Show 28 Study Locations
Sponsors and Collaborators
Eiger BioPharmaceuticals

Publications:
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Responsible Party: Eiger BioPharmaceuticals
ClinicalTrials.gov Identifier: NCT02736149     History of Changes
Other Study ID Numbers: EIG-UBX-002
First Posted: April 13, 2016    Key Record Dates
Last Update Posted: July 18, 2019
Last Verified: July 2019

Additional relevant MeSH terms:
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Hypertension
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases
Ubenimex
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents