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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000011427
Receipt No. 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

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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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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