Ubenimex in Adult Patients With Lymphedema of The Lower Limb (ULTRA)

Status Completed

Clinical Trial Summary

This proof-of-concept study is designed as a randomized, double-blind, placebo-controlled study comparing ubenimex at 150 mg, 3 times daily (total daily dose of 450 mg) with placebo for 6 months treatment period in patients with leg lymphedema.

Clinical Trial Description

Leukotriene B4 (LTB4) inhibits lymphangiogenesis in the mouse tail model of lymphedema and is elevated in tissue in patients with lymphedema. Ubenimex is an inhibitor of leukotriene A4 hydrolase (LTA4H), the biosynthetic enzyme for LTB4. This proof-of-concept study is designed as a randomized, double-blind, placebo-controlled study comparing ubenimex at 150 mg, 3 times daily (total daily dose of 450 mg) with placebo for 6 months treatment period in patients with leg lymphedema. The primary objectives for the study are: - To evaluate the efficacy of ubenimex in patients with leg lymphedema - To evaluate the safety and tolerability of ubenimex in patients with leg lymphedema ;

Study Design

Related Conditions & MeSH terms

Lymphedema

Clinical Trial Details

NCT number	NCT02700529
Study type	Interventional
Source	Eiger BioPharmaceuticals
Contact
Status	Completed
Phase	Phase 2
Start date	June 2016
Completion date	February 2019

View Details

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