A Study to Investigate Efficacy and Safety of KP-001 Compared With Placebo in Patients Aged ≥2 Years With Common VM, Common LM, or KTS/CLOVES Syndrome

Recruiting Phase 3 Interventional Study
Venous Malformations Lymphatic Malformations Klippel-Trenaunay Syndrome CLOVES Syndrome
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
2 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
150 (estimated)
Sponsor
Kaken Pharmaceutical · Industry
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About This Trial
This is a phase 3, double-blind, randomized, placebo-controlled, parallel group, adaptive, multicenter study planned to be conducted at multiple sites in North America, Canada, Taiwan and South Korea. The purpose of this study is to measure the efficacy and safety of KP-001 compared with placebo in patients aged ≥2 years with common VM, common LM, or KTS/CLOVES syndrome. An independent data moni…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Patients aged 2 years or older at the time of consent or assent. 2. Patients diagnosed with ISSVA classification of common VM, common (cystic) LM (including mixed type consisting mainly of either VM or LM), or KTS/CLOVES syndrome. 3. Patients who cannot be cured by resection,…
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+818059831020

S-KY@aadibio.com

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