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

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000011427

Enrollment

Registered

2013-08-08

Start date

2013-08-26

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary lymphedema

Interventions

AMG0001 is injected to the affected limb.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Written informed consent (2) 20-64 years old (3) The age of onset is under 60 years (4) Subjects with unilateral edema

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Change in volume of edema	—

Secondary

Measure	Time frame
QOL, lymphscintigraphy, ICG fluorescence imaging, ultrasound, etc	—

Countries

Japan

Contacts

Public ContactChieka SASAKURA

AnGes MG, Inc. Clinical Development Department 1

crinfo@anges.co.jp03-5730-2488

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026