JPRN-jRCT2041230065
Recruiting
Phase 3
A Long-term Study of KP-001 in patients with vascular malformation including venous malformation, lymphatic malformation, and Klippel-Trenaunay Syndrome (Phase III)
Hideki Kawabata0 sites50 target enrollmentAugust 3, 2023
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Vascular malformation including VM, LM, and KTS
- Sponsor
- Hideki Kawabata
- Enrollment
- 50
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Patients who complete the 52\-week treatment period in the Phase III confirmatory study and are diagnosed as requiring continuation of investigational drug beyond 52 weeks.
- •1\. Patient is at least 2 years of age at time of consent
- •2\. Diagnosed as one of the following \- ISSVA classification of Common VM, Common (cystic) LM (including combined type mainly consisting of VM or LM)
- •\- Klippel\-Trenaunay Syndrome
- •\- Megalencephaly\-capillary malformation\-polymicrogyria
- •\- Lymphangiomatosis
- •\- Lymphangioleiomyomatosis in Gorham\-Stout disease
- •\- Lymphangiectasia
- •\- Familial VM cutaneo\-mucosal
- •\- CLOVES syndrome
Exclusion Criteria
- •1\. Diagnosed as having diabetes mellitus (type I or II) or a disease with abnormal glucose metabolism (glycogen storage disease, hypergalactosemia, primary lactose intolerance, etc.) and poor control of the disease
- •2\. Diagnosed as having hepatic or renal impairment
- •3\. Patients with ischemic heart disease, arrhythmia, or heart failure (NYHA III or IV degree) diagnosed as inadequately controlled
- •4\. Patients who wear orthodontic appliances, cochlear implants, etc., which may affect MRI imaging.
- •1\. Diagnosed as having diabetes mellitus (type I or II) or a disease with abnormal glucose metabolism (glycogen storage disease, hypergalactosemia, primary lactose intolerance, etc.) and poor control of the disease
- •2\. Diagnosed as having hepatic or renal impairment
- •3\. Patients with ischemic heart disease, arrhythmia, or heart failure (NYHA III or IV degree) diagnosed as inadequately controlled
- •4\. Patients who are unable to take drug orally
- •5\. Patients who wear orthodontic appliances, cochlear implants, etc., which may affect MRI imaging. (Only for subjects whose target lesions are assessed by MRI imaging)
- •6\. Patients with target lesion infection requiring treatment within 28 days prior to the date of consent
Outcomes
Primary Outcomes
Not specified
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