Unique ID issued by UMIN | UMIN000011427 |
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Receipt number | R000013371 |
Scientific Title | A phase 1 / 2 trial of AMG0001 in patients with primary lymphedema |
Date of disclosure of the study information | 2013/08/08 |
Last modified on | 2019/07/25 16:43:30 |
A phase 1 / 2 trial of AMG0001 in patients with primary lymphedema
A phase 1 / 2 trial of AMG0001 in patients with primary lymphedema
A phase 1 / 2 trial of AMG0001 in patients with primary lymphedema
A phase 1 / 2 trial of AMG0001 in patients with primary lymphedema
Japan |
Primary lymphedema
Vascular surgery | Plastic surgery |
Others
NO
To assess the safety and efficacy of AMG0001 for primary lymphedema
Safety,Efficacy
Phase I,II
Change in volume of edema
QOL, lymphscintigraphy, ICG fluorescence imaging, ultrasound, etc
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
AMG0001 is injected to the affected limb.
20 | years-old | <= |
65 | years-old | > |
Male and Female
(1) Written informed consent
(2) 20-64 years old
(3) The age of onset is under 60 years
(4) Subjects with unilateral edema
(1) Fibrosis has supervened and become irreversible (ISL late stage II or worse).
(2) Morphologically classified into hyperplasia
(3) Lymphedema as a congenital associated malformation (e.g. Klippel-Trenaunay-Weber syndrome, Noonan syndrome, Turner's syndrome).
(4) History, diagnosis or suspicion of malignant neoplasm.
(5) History of invasive treatment for lymphedema (e.g. surgical reduction, liposuction, lymphaticovenous Anastomosis within 5 years), or history of surgery under general/spinal anesthesia in the affected limb.
20
1st name | Tadahiro |
Middle name | |
Last name | Sasajima |
Asahikawa Medical University
Professor emeritus
0788510
2-1-1-1 Midorigaoka-Higashi, Asahikawa, Hokkaido, Japan
0166-65-2111
sasajima@asahikawa-med.ac.jp
1st name | Chieka |
Middle name | |
Last name | SASAKURA |
AnGes MG, Inc.
Clinical Development Department 1
1080014
Shiba 4-13-3, Minato-ku, Tokyo, Japan
03-5730-2488
crinfo@anges.co.jp
AnGes MG, Inc.
AnGes MG, Inc.
Profit organization
Tokushima University Hospital
2-50-1, Kuramoto-cho, Tokushima, Japan
088-633-9294
awachiken@tokushima-u.ac.jp
NO
2013 | Year | 08 | Month | 08 | Day |
Unpublished
No longer recruiting
2013 | Year | 06 | Month | 20 | Day |
2013 | Year | 08 | Month | 26 | Day |
2013 | Year | 08 | Month | 08 | Day |
2019 | Year | 07 | Month | 25 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013371
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