Active Clinical Trials
EIG-UBX-002: 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)
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).
Ages Eligible for Study: 18 Years to 75 Years (Adult, Senior)
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
- 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.
- 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.