A Study of Ubenimex in Patients With Pulmonary Arterial Hypertension (WHO Group 1) (LIBERTY)
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|ClinicalTrials.gov Identifier: NCT02664558|
Recruitment Status : Completed
First Posted : January 27, 2016
Last Update Posted : November 15, 2018
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 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/New York Heart Association (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.
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Arterial Hypertension||Drug: ubenimex Other: placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||61 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 2, Randomized, Double-BLInd, Placebo- Controlled Study of UBEnimex in Patients With Pulmonary ARTerial HYpertension (WHO Group 1) (LIBERTY)|
|Study Start Date :||April 2016|
|Actual Primary Completion Date :||November 2017|
|Actual Study Completion Date :||January 2018|
ubenimex capsules 150 mg three times a day (TID), administered orally for a total of 24 weeks.
Placebo Comparator: placebo
placebo capsules TID, administered orally for a total of 24 weeks
- Change in pulmonary vascular resistance (PVR). [ Time Frame: Week 24 ]
- Change in exercise capacity as determined by 6-minute walk distance (6MWD). [ Time Frame: Week 24 ]
- Change in Borg dyspnea score. [ Time Frame: Week 24 ]
- Change in World Health Organization/New York Heart Association Functional Classification [ Time Frame: Week 24 ]
- Time to clinical worsening (TTCW) will be assessed and will be evaluated as the number of days between the first dose of study drug and the occurrence of a predefined clinical worsening event [ Time Frame: 24 weeks ]
- QoL questionnaire (CAMPHOR, Cambridge Pulmonary Hypertension Outcome Review) [ Time Frame: week 24 ]
- Change in disease biomarkers brain natriuretic peptide (BNP) /N-terminal pro-brain natriuretic peptide (NT-proBNP ) [ Time Frame: week 24 ]
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): NCT02664558