UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033159 |
|---|---|
| Receipt number | 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 | 2022/06/29 09:31:44 |
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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
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
lymph_chiken@asahikawa-med.ac.jp
Sponsor or person
Institute
Asahikawa medical university
Institute
Department
Personal name
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
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
Completed
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
| 2022 | Year | 06 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037816
