May. 25, 2021 |
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April. 02, 2023 |
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jRCT2071210027 |
Phase 2 clinical trial evaluating the efficacy and safety of ART-001 in patients with slow-flow vascular malformations |
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Phase 2 clinical trial evaluating the efficacy and safety of ART-001 in patients with slow-flow vascular malformations |
Nagabukuro Hiroshi |
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ARTham Therapeutics, Inc |
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24-8, Yamashita-cho, Naka-ku, Yokohama Kanagawa |
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+81-45-225-8858 |
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art-001@arthamther.com |
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Tanaka Akira |
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ARTham Therapeutics, Inc |
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24-8, Yamashita-cho, Naka-ku, Yokohama Kanagawa |
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+81-45-225-8858 |
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art-001@arthamther.com |
Complete |
July. 01, 2021 |
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Aug. 12, 2021 | ||
34 | ||
Interventional |
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randomized controlled trial |
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double blind |
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dose comparison control |
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parallel assignment |
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treatment purpose |
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1) All sexes, 2 years old and older |
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1) Patients with diabetes (type I or type II) or diseases that cause abnormal glucose metabolism |
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2age old over | ||
No limit | ||
Both |
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Slow flow vascular malformations |
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Perticipants will be orally taking 50 mg or 100 mg of ART-001 once daily after breakfast |
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Proportion of participants with response defined by MRI volumetric change of target lesion at Week 24 |
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Efficacy |
ARTham Therapeutics, Inc |
Oita Univercity Hospital Institutional Review Board | |
1-1 Idaigaoka, Hasama-machi, Yufu City, Oita | |
+81-97-586-6163 |
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gcrcjimu@oita-u.ac.jp | |
Approval | |
No |
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none |