JPRN-jRCT2071210027
Completed
Phase 2
Phase 2 clinical trial evaluating the efficacy and safety of ART-001 in patients with slow-flow vascular malformations
agabukuro Hiroshi0 sites34 target enrollmentMay 25, 2021
ConditionsSlow flow vascular malformations
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Slow flow vascular malformations
- Sponsor
- agabukuro Hiroshi
- Enrollment
- 34
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) All sexes, 2 years old and older
- •2\) Patients with a diagonisis of venous malformation, lymphatic malformation (lymphangioma) or Klippel\-Trenone syndrome.
- •3\) Patients must have symptoms caused by slow\-flow vascular malformation (i.e. pain, inflammation such as repeated cellulitis, bleeding, disfigurement, etc.)
- •4\) Patients who have a intractable slow\-flow vascular malformation (i.e. poor response or recurrence for standard treatment, multiple lesions, inoperable, thrombotic, etc.)
- •5\) Patients with at least one lesions whose volume is measurableby MRI
- •6\) Written consent to participate in this clinical trial has been given by the patient, or by the parent or a legal guardian (for pediatric patients).
Exclusion Criteria
- •1\) Patients with diabetes (type I or type II) or diseases that cause abnormal glucose metabolism
- •2\) Patients with renal dysfunction
- •3\) Patients with liver dysfunction
- •4\) Patients with poorly controlled ischemic heart disease, arrhythmia, or heart failure (NYHA III or IV degree)
- •5\) Patients taking drugs that have CYP3A4 inhibitory or inducing effects
- •6\) Patients with gastrointestinal disorders that affect drug absorption
- •7\) Patients who cannot take the drug orally
- •8\) Patients with orthodontic appliances, cochlear implants, etc. that may affect MRI image evaluation
- •9\) Patients with inflammatory infections requiring treatment for target lesions within 4 weeks at time of informed consent
- •10\) Patients who received invasive treatment including sclerotherapy or laser therapy for target lesions within 12 weeks at time of informed consent
Outcomes
Primary Outcomes
Not specified
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