NCT02736149

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

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)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Eiger BioPharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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, extension study to evaluate long-term safety and efficacy of ubenimex in patients with PAH (WHO Group 1) who complete Study EIG-UBX-001.

Detailed 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).

Conditions

• Pulmonary Arterial Hypertension

Interventions

Type	Name	Description
DRUG	ubenimex

Timeline

• Start date: 2016-12-01
• Primary completion: 2018-03-01
• Completion: 2018-08-01
• First posted: 2016-04-13
• Last updated: 2023-01-18
• Results posted: 2023-01-18

Locations

28 sites across 2 countries: United States, Canada