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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000730
Receipt No. R000000877
Scientific Title Randomized, double-blind, placebo-controlled study of AMG0001(HGF plasmid) for patients with arteriosclerosis obliterans
Date of disclosure of the study information 2007/06/04
Last modified on 2010/10/06

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Basic information
Public title Randomized, double-blind, placebo-controlled study of AMG0001(HGF plasmid) for patients with arteriosclerosis obliterans
Acronym Randomized, double-blind, placebo-controlled study of AMG0001(HGF plasmid) for patients with arteriosclerosis obliterans
Scientific Title Randomized, double-blind, placebo-controlled study of AMG0001(HGF plasmid) for patients with arteriosclerosis obliterans
Scientific Title:Acronym Randomized, double-blind, placebo-controlled study of AMG0001(HGF plasmid) for patients with arteriosclerosis obliterans
Region
Japan

Condition
Condition Arteriosclerosis obliterans
Classification by specialty
Cardiology Vascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The superiority of the efficacy of AMG0001 for arteriosclerosis obliterans (ASO) over placebo will be determined using the ischemic ulcer improvement rate and resting pain improvement rate as major variables.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes Improvement of pain at rest and ischemic ulcer
Key secondary outcomes Time course of pain at rest and Ischemic ulcer
Ankle brachial index
Fontaine classification
Angiogenesis
Incidence of subjects without analgesic
Quality of life
Amputation of drug-administered leg
Adverse events
Investigations and vital signs
Serum HGF level
Serum anti-HGF antibody
Serum anti-Escherichia protein antibody
Serum anti-DNA antibody

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 An AMG0001 formulation (2.5 mg/ml, 1.85 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 A placebo, an injectable form externally indistinguishable from the AMG0001 formulation, will be prepared before use and administered to 8 sites in the same manner as the AMG0001 formulation.
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
40 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 40 or older but younger than 85
3. Fontaine III (resting pain) or IV (ischemic ulcer)
4. Patients in whom hemodynamic parameters meet both of the following criteria:
* ABPI at rest is not more than 0.6 during the observation period.
* The mean ankle pressure is less than 70 mmHg during the observation period.
5. Patients in whom revascularization in the treated limb is difficult
6. Patients in whom symptoms are not improved in the treated limbs despite the conduct of conventional medical treatment or intervention for 4 weeks or more
7. Patients who agree to contraception by a sperm passage blocking method until the end of Week 12 of treatment after giving informed consent
Key exclusion criteria 1. Patients with a necrotized ulcer and/or an ulcer with exposed tendon or bone
2. Patients in whom alcohol or drug dependence had been noted 90 days or less before informed consent was obtained or who had been treated for it
3. Past history of or complication with cancer
4. Patients with serious cardiac, hepatic, renal, or hematological disease
5. Patients with intercurrent hepatitis B or C, AIDS, or ATL
6. Patients who underwent revascularization or amputation (not necrotomy) 90 days or less before giving informed consent
7. Patients who underwent sympathectomy or sympathetic block 180 days or less before giving informed consent
8. Patients with an invasive infectious disease which is difficult to control with antibiotics
9. Patients with proliferating diabetic retinopathy (untreated or in the middle or late stage of proliferating retinopathy) or neovascularization-type age-related macular degeneration
10. Participation in another clinical trial 90 days or less before giving informed consent
11. Pregnant or breast-feeding women, women with suspected pregnancy, and women who desire to become pregnant during the trial
12. Past history of cell therapy
13. Past history of gene therapy
14. Blood sampling (or donation) of 200 ml or more, 30 days or less before giving informed consent, or 400 ml or more, 90 (120 in the case of women) days or less before giving informed consent
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Shigematsu
Organization Tokyo Medical University
Division name Second Department of Surgery
Zip code
Address 6-7-1, nishi-shinjuku, Shinjuku-ku, Tokyo, Japan 160-0023
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Anges MG, Inc.
Division name Regulatory affairs
Zip code
Address 5-20-14, shiba, Minato-ku, Tokyo, Japan 108-0014
TEL
Homepage URL
Email

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 Japan

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

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 JapicCTI-050186
Org. issuing International ID_1 Japan Pharmaceutical Information Center
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2007 Year 06 Month 04 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pubmed/20393508
Number of participants that the trial has enrolled
Results Analysis of efficacy was performed in 40 patients with critical limb ischemia (CLI).
The primary end point was the improvement of rest pain in patients without ulcers (Rutherford 4) or the reduction of ulcer size in patients with ulcer(s) (Rutherford 5).
The overall improvement rate of the primary end point was 70.4% (19/27) in HGF group and 30.8% (4/13) in placebo group, showing a significant difference (P=0.014). In Rutherford 5 patients, HGF achieved a significantly higher improvement rate (100% [11/11]) than placebo (40% [2/5]; P=0.018). HGF plasmid also improved QOL. There were no major safety problems. HGF gene therapy is safe and effective for CLI.

Gene Ther. 2010 Sep;17(9):1152-61. Epub 2010 Apr 15.
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
2003 Year 11 Month 14 Day
Date of IRB
Anticipated trial start date
2004 Year 02 Month 01 Day
Last follow-up date
2008 Year 08 Month 01 Day
Date of closure to data entry
2008 Year 09 Month 01 Day
Date trial data considered complete
2008 Year 10 Month 01 Day
Date analysis concluded
2009 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2007 Year 06 Month 04 Day
Last modified on
2010 Year 10 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000877

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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