UMIN-CTR Clinical Trial

Basic information
Public title	A phase 1 / 2 trial of AMG0001 in patients with primary lymphedema
Acronym	A phase 1 / 2 trial of AMG0001 in patients with primary lymphedema
Scientific Title	A phase 1 / 2 trial of AMG0001 in patients with primary lymphedema
Scientific Title:Acronym	A phase 1 / 2 trial of AMG0001 in patients with primary lymphedema
Region	Japan

Condition
Condition	Primary lymphedema
Classification by specialty	Vascular surgery Plastic surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the safety and efficacy of AMG0001 for primary lymphedema
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase I,II

Assessment
Primary outcomes	Change in volume of edema
Key secondary outcomes	QOL, lymphscintigraphy, ICG fluorescence imaging, ultrasound, etc

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	AMG0001 is injected to the affected limb.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	65 years-old >
Gender	Male and Female
Key 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
Key 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.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Tadahiro Middle name Last name Sasajima
Organization	Asahikawa Medical University
Division name	Professor emeritus
Zip code	0788510
Address	2-1-1-1 Midorigaoka-Higashi, Asahikawa, Hokkaido, Japan
TEL	0166-65-2111
Email	sasajima@asahikawa-med.ac.jp

Public contact
Name of contact person	1st name Chieka Middle name Last name SASAKURA
Organization	AnGes MG, Inc.
Division name	Clinical Development Department 1
Zip code	1080014
Address	Shiba 4-13-3, Minato-ku, Tokyo, Japan
TEL	03-5730-2488
Homepage URL
Email	crinfo@anges.co.jp

Sponsor
Institute	AnGes MG, Inc.
Institute
Department

Funding Source
Organization	AnGes MG, Inc.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Tokushima University Hospital
Address	2-50-1, Kuramoto-cho, Tokushima, Japan
Tel	088-633-9294
Email	awachiken@tokushima-u.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2013 Year 08 Month 08 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2013 Year 06 Month 20 Day
Date of IRB
Anticipated trial start date	2013 Year 08 Month 26 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2013 Year 08 Month 08 Day
Last modified on	2019 Year 07 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013371