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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02736149
• Date of registration: 04/04/2016
• Prospective Registration: Yes
• Primary sponsor: Eiger BioPharmaceuticals
• Public title: Open-Label Extension Study of Ubenimex in Patients With Pulmonary Arterial Hypertension (WHO Group 1) LIBERTY2
• Scientific 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)
• Date of first enrolment: December 2016
• Target sample size: 51
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02736149
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Canada, United States

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Pulmonary Arterial Hypertension

Intervention(s)

Drug: ubenimex

Primary Outcome(s)

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

Secondary Outcome(s)

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]

Change in World Health Organization/New York Heart Association Functional Classification [Time Frame: through study completion, an average of 1 year]

Change in exercise capacity as measured by 6-minute walk distance (6MWD) [Time Frame: through study completion, an average of 1 year]

Change in pulmonary vascular resistance (PVR) [Time Frame: through study completion, an average of 1 year]

Secondary ID(s)

EIG-UBX-002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors