A phase 1 / 2 trial of AMG0001 in patients with primary lymphedema
Phase 1
- Conditions
- Primary lymphedema
- Registration Number
- JPRN-UMIN000011427
- Lead Sponsor
- AnGes MG, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
Not provided
Exclusion Criteria
(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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method