Open-Label Extension Study of Ubenimex in Patients With Pulmonary Arterial Hypertension (WHO Group 1) (LIBERTY2)
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|ClinicalTrials.gov Identifier: NCT02736149|
Recruitment Status : Terminated (Following the failure to demonstrate efficacy in EIG-UBX-001, the sponsor decided to terminate Study EIG-UBX-002.)
First Posted : April 13, 2016
Last Update Posted : July 18, 2019
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).
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Arterial Hypertension||Drug: ubenimex||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||51 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official 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)|
|Study Start Date :||December 2016|
|Actual Primary Completion Date :||March 2018|
|Actual Study Completion Date :||August 2018|
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-emergent adverse events recorded on the Adverse Event Case Report Form [ 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 ]
- Change in exercise capacity as measured by 6-minute walk distance (6MWD) [ 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 disease biomarkers brain natriuretic peptide (BNP) /N-terminal pro-brain natriuretic peptide (NT-proBNP ) [ Time Frame: through study completion, an average of 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02736149
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