Summary

for people ages 18-75 (full criteria)
at La Jolla, California and other locations
study started
estimated completion:

Description

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).

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)

Keywords

Pulmonary Arterial Hypertension Hypertension Familial Primary Pulmonary Hypertension Ubenimex

Eligibility

You can join if…

Open to people ages 18-75

  • 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 CAN'T join 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.

Locations

  • UCSD Medical Center
    La Jolla California 92103 United States
  • Stanford University Medical Center
    Palo Alto California 94305 United States
  • University of Colorado Cardiac and Vascular Center
    Aurora Colorado 80045 United States
  • University Texas Health Science Center
    San Antonio Texas 78229 United States
  • UT Southwestern Medical Center
    Dallas Texas 75390 United States
  • Houston Methodist Hospital
    Houston Texas 77030 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Eiger BioPharmaceuticals
ID
NCT02736149
Phase
Phase 2
Study Type
Interventional
Last Updated
January 31, 2018