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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000033159
Receipt No. R000037816
Scientific Title Phase2 Clinical Trial of Hepatocyte Growth Factor Gene Therapy for Primary Lymphedema
Date of disclosure of the study information 2018/07/01
Last modified on 2020/07/01

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Basic information
Public title Phase2 Clinical Trial of Hepatocyte Growth Factor Gene Therapy for Primary Lymphedema
Acronym Phase2 Clinical Trial for Primary Lymphedema
Scientific Title Phase2 Clinical Trial of Hepatocyte Growth Factor Gene Therapy for Primary Lymphedema
Scientific Title:Acronym Phase2 Clinical Trial for Primary Lymphedema
Region
Japan

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

Objectives
Narrative objectives1 The goal of the present study was to develop the novel gene therapy for lymphedema using hepatocyte growth factor (HGF) plasmid DNA.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Quality of Life (SF-36 and LYMQOL) at 12 and 24 week
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking YES
Concealment Central registration

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Gene
Interventions/Control_1 Placebo (Saline 3.0ml x8, im)
Interventions/Control_2 Low dose (HGF plasmid DNA 0.05mg/3ml x8, im)
Interventions/Control_3 High dose (HGF plasmid DNA 0.5mg/3ml x8, im)
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
75 years-old >
Gender Male and Female
Key inclusion criteria 1, agree to join the study by a document
2, 20<=age<75
3, age of onset <60
4, edema of one limb, the volume is over 20% compared with another side.
5, diagnosed by lymph scintigraphy
6, treated by physical therapy over 3 months
7, agree to prevent pregnancy
Key exclusion criteria 1, stage 3 by ISL classification
2, aplasia or hyperplasia
3, another hereditary
4, malignancy
5, cellulitis at the time of registration
6, received the operation within 90 days
7, severe disease of liver, kidney, heart, or blood
8, alcohol dependence
9, registration of another clinical trials within 90 days
10, the pregnant
11, received the treatment of another gene therapy
12, unfitness patient
Target sample size 9

Research contact person
Name of lead principal investigator
1st name Yukihiro
Middle name
Last name Saito
Organization Asahikawa medical university
Division name Dep. Surgery, Div. Vascular surgery
Zip code 078-8510
Address 2-1-1-1 Midorigaoka-Higashi, Asahikawa, Hokkaido, Japan
TEL 0166-68-2880
Email lymph_chiken@asahikawa-med.ac.jp

Public contact
Name of contact person
1st name Yukihiro
Middle name
Last name Saito
Organization Asahikawa medical university
Division name Dep. Surgery, Div. Vascular surgery
Zip code 078-8510
Address 2-1-1-1 Midorigaoka-Higashi, Asahikawa, Hokkaido, Japan
TEL 0166-68-2880
Homepage URL
Email lymph_chiken@asahikawa-med.ac.jp

Sponsor
Institute Asahikawa medical university
Institute
Department

Funding Source
Organization Asahikawa medical university
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Asahikawa medical university
Address 2-1-1-1 Midorigaoka-Higashi, Asahikawa, Hokkaido, Japan
Tel 0166-68-2880
Email lymph_chiken@asahikawa-med.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
2018 Year 07 Month 01 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
2018 Year 05 Month 21 Day
Date of IRB
2018 Year 05 Month 17 Day
Anticipated trial start date
2018 Year 08 Month 07 Day
Last follow-up date
2019 Year 09 Month 19 Day
Date of closure to data entry
2019 Year 10 Month 30 Day
Date trial data considered complete
2019 Year 11 Month 01 Day
Date analysis concluded
2020 Year 09 Month 30 Day

Other
Other related information

Management information
Registered date
2018 Year 06 Month 27 Day
Last modified on
2020 Year 07 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037816

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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