NCT02664558

A Study of Ubenimex in Patients With Pulmonary Arterial Hypertension (WHO Group 1)

A Phase 2, Randomized, Double-BLInd, Placebo- Controlled Study of UBEnimex in Patients With Pulmonary ARTerial HYpertension (WHO Group 1) (LIBERTY)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Eiger BioPharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This proof-of-concept study is designed as a Phase 2, multicenter, randomized, double-blind, placebo controlled study comparing ubenimex with placebo in patients with pulmonary arterial hypertension (PAH) (World Health Organization \[WHO\] Group 1) and have a WHO/New York Heart Association (NYHA) Functional Classification (WHO/NYHA-FC) of II or III.

Detailed description

Ubenimex is being developed for the treatment of PAH (WHO Group 1) to improve exercise capacity and delay clinical worsening. This proof-of-concept study is designed as a Phase 2, multicenter, randomized, double-blind, placebo controlled study comparing ubenimex with placebo in patients with PAH (WHO Group 1) and have a WHO/NYHA Functional Classification (WHO/NYHA-FC) of II or III. The Primary Objectives for the study are: * To evaluate the efficacy of ubenimex in patients with PAH (WHO Group 1). * To evaluate the safety and tolerability of ubenimex in patients with WHO Group 1 PAH.

Conditions

• Pulmonary Arterial Hypertension

Interventions

Type	Name	Description
DRUG	ubenimex
OTHER	placebo

Timeline

• Start date: 2016-04-01
• Primary completion: 2017-11-01
• Completion: 2018-01-01
• First posted: 2016-01-27
• Last updated: 2023-03-06
• Results posted: 2023-03-06

Locations

31 sites across 2 countries: United States, Canada