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

Eiger BioPharmaceuticals

Status and phase: Terminated; Phase 2

Conditions: Pulmonary Arterial Hypertension

Treatments: Drug: ubenimex

Study type: Interventional

Funder types: Industry

Identifiers

NCT02736149

EIG-UBX-002

Details and patient eligibility

About

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.

Full 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).

Enrollment: 51 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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51 participants in 1 patient group

ubenimex

Experimental group

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.

Treatment:

Drug: ubenimex