UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000730 |
|---|---|
| Receipt number | 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 10:49:06 |
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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
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
Sponsor or person
Institute
Anges MG, Inc.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000877
