UMIN-CTR Clinical Trial

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	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037816