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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000014918
Receipt No. R000017293
Scientific Title Gene Therapy using Intramuscular Administration of AMG0001 in Patients with Peripheral Arterial Disease
Date of disclosure of the study information 2014/08/30
Last modified on 2019/08/28

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Basic information
Public title Gene Therapy using Intramuscular Administration of AMG0001 in Patients with Peripheral Arterial Disease
Acronym Angiogenic Gene Therapy with HGF Gene
Scientific Title Gene Therapy using Intramuscular Administration of AMG0001 in Patients with Peripheral Arterial Disease
Scientific Title:Acronym Angiogenic Gene Therapy with HGF Gene
Region
Japan

Condition
Condition Arteriosclerosis Obliterans (ASO)
Buerger's disease (Thromboangiitis Obliterans: TAO)
Classification by specialty
Medicine in general Cardiology Vascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The effectiveness and safety of AMG0001 for arteriosclerosis obliterans (ASO) and Buerger's disease will be examined.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Improvement of pain at rest and ischemic ulcer
Key secondary outcomes

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 Gene
Interventions/Control_1 An AMG0001 formulation (2.5 mg/ml, 2.1 ml/vial) will be prepared before use and administered to 8 sites with ischemia in the target limb, 0.5 mg of AMG0001 per site (total dose: 4.0 mg).
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
85 years-old >
Gender Male and Female
Key inclusion criteria (1) Patients who personally give informed consent in writing
(2) Patients aged 20 or older but younger than 85
(3) Patients who have a stenosis or occlusion in superficial femoral artery, popliteal artery, or artery below the popliteal of the treated limb confirmed by MRA or CTA.
(4) The mean ankle pressure is less than 70 mmHg or ABI is not more than 0.6 during the observation period. (However, this shall not apply in the case of Buerger's disease.)
(5) Those who have the following clinical symptoms due to stenosis or occlusion.
・ Rest pain(Fontaine III)
VAS is at least 20 mm during the observation period
・ Ulcer(Fontaine IV)
(6) Patients in whom revascularization in the treated limb is difficult, or patients who are determined that the adaptation is not impossible but there are some risks in surgery
(7) Patients showing no symptom of improvement in the treated limb despite the conduct of conventional medical treatment or intervention for more than two weeks in the observation period after obtaining informed consent. The conventional medical treatment or intervention needs to be continued more than two weeks before obtaining the informed consent.
(8) Patients who agree to contraception by a sperm passage blocking method until the end of Week 12 of treatment after obtaining informed consent
(9) Inpatient, outpatient allowed
Key exclusion criteria (1) Patients with a necrotized ulcer and/or an ulcer with exposed tendon or bone in the treated or non-treated limb
(2) Patients in whom alcohol or drug dependence had been noted 90 days or less before obtaining informed consent
(3) Patient with malignant tumor history or merger. Patients with no recurrence of breast cancer more than 10 years, and with no recurrence of all other tumor types before obtaining informed consent, may be enrolled in the clinical research. Patients must been completed the cancer screening tests as defined in the protocol.
(4) Patient with serious cardiac, renal or hematological disease, but excluding plateau chronic maintenance dialysis patients.
(5) Patients with HIV antigen or antibody positive
(6) Patients who underwent revascularization or amputation in the treated or non-treated limb, excluding small incision, necrotomy or onychectomy etc.
(7) Patients who underwent sympathectomy or sympathetic block 90 days or less before obtaining informed consent
(8) Patients with an invasive infectious disease which is difficult to control with antibiotics
(9) Patients with proliferative diabetic retinopathy of untreated or treatment-resistant, or patients with neovascularization-type age-related macular degeneration
(10) Patients with diabetic neuropathy (diffuse symmetrical neuropathy)
(11) Participation in another clinical trial 30 days or less before obtaining informed consent
(12) Past history of gene therapy excluding AMG0001
(13) Pregnant or breast-feeding women, women with suspected pregnancy, and women who desire to become pregnant during the clinical research
(14) Patients who were judged to be unsuitable for the clinical research by the attending physician
Target sample size 6

Research contact person
Name of lead principal investigator
1st name Hiromi
Middle name
Last name Rakugi
Organization Osaka University Hospital
Division name Geriatrics and Hypertension
Zip code 565-0871
Address B-6, 2-2 Yamadaoka Suita,Osaka
TEL 06-6879-3852
Email rakugi@geriat.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name Munehisa
Middle name
Last name Shimamura
Organization Osaka University Graduate School of Medicine
Division name Department of Health Development and Medicine
Zip code 565-0871
Address 2-2 Yamada-oka, Suita, Osaka
TEL 06-6210-8359
Homepage URL
Email shimamuu@cgt.med.osaka-u.ac.jp

Sponsor
Institute Osaka University Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s) AnGes MG, Inc.

IRB Contact (For public release)
Organization Department of Medical Innovation Osaka University Hospital, Osaka University Hospital
Address Yamada-oka 2-2, Suita, Osaka, 565-0871, Japan
Tel 06-6210-8296
Email irb-jimu@hp-mctr.med.osaka-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
2014 Year 08 Month 30 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 6
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
2014 Year 08 Month 07 Day
Date of IRB
2014 Year 02 Month 20 Day
Anticipated trial start date
2014 Year 09 Month 08 Day
Last follow-up date
2019 Year 04 Month 17 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 08 Month 21 Day
Last modified on
2019 Year 08 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017293

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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