Status:
UNKNOWN
Randomized Phase IIb Trial of DVC1-0101
Lead Sponsor:
Kyushu University
Collaborating Sponsors:
Ministry of Health, Labour and Welfare, Japan
Japan Agency for Medical Research and Development
Conditions:
Intermittent Claudication
Peripheral Arterial Disease
Eligibility:
All Genders
30+ years
Phase:
PHASE2
Brief Summary
DVC1-0101 is a gene therapy medicine to treat peripheral arterial disease (PAD) based on recombinant F-gene-deleted, non-transmissible Sendai virus (rSeV/dF) expressing human fibroblast growth factor-...
Detailed Description
DVC1-0101 is a gene therapy medicine to treat peripheral arterial disease (PAD) based on recombinant F-gene-deleted, non-transmissible Sendai virus (rSeV/dF) expressing human fibroblast growth factor-...
Eligibility Criteria
Inclusion
- 1\) Meet criteria (1) to (5) below and are confirmed as such by at least 1 specialist qualified by the Japanese Society for Cardiovascular Surgery and at least 1 physician with deep experience Cardiovascular Intervention.
- arteriosclerosis obliterans with stable symptoms, have intermittent claudication (ACD \< 260 m) and are able to walk on a treadmill
- resting ankle-brachial pressure index \< 0.9
- refuse revascularization, risk of revascularization may be greater than the benefit, or develop obliteration after revascularization
- angiographic findings show patency from the abdominal aorta through to the proximal side of the external iliac artery
- angiographic findings meet the above criterion (4), and have stenosis or obliteration under the femoropopliteal region with morphology defined as type C or D based on TASCII
- 2\) Administering cilostazol for at least 1 month and still meet criterion 1).
- 3\) Aged 30 and over.
- 4\) Either sex, either inpatients or outpatients.
- 5\) Able to give written consent for themselves.
Exclusion
- Have ischemic ulcer.
- Diagnosed with Buerger's disease.
- Have a current or past history of life-threatening allergies.
- Have been shown or are suspected to have cancer.
- With concurrent proliferative intraocular neovascularization.
- With poorly controlled diabetes mellitus.
- With concurrent cardiac failure.
- With untreated severe arrhythmia.
- Have or are suspected to have interstitial pneumonia.
- Have progressive hepatic disorders.
- Have moderate or severe hepatic disorders. (1) aspartate aminotransferase or alanine aminotransferase \>2.5 times the upper limit (2) Prothrombin time is 14 seconds or longer (3) Serum bilirubin \>2.0 times the upper limit
- Diagnosed with hepatic cirrhosis (classified as B or C on the Child-Pugh).
- Have an inflammatory disease.
- Treated with immunosuppressants or corticosteroids for the treatment of various inflammatory diseases or after organ transplantation.
- Underwent extirpative surgery of a malignant tumor in the past 5 years.
- Have had a cerebral hemorrhage or cerebral infarction in the past 6 months.
- With blood diseases.
- With moderate or severe renal dysfunction (CCr \<40 mL/min)
- With alcohol or drug dependence.
- Pregnant/lactating female, or who wish or are suspected to be pregnant.
- Positive HIV antibodies.
- Took part in any other clinical studies or research in the past 30 days.
- Have allergic to the antibiotics and/or the Ribavirin.
- Not permitted to participate in this study by the principal investigator or sub-investigator for any other reasons.
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT02276937
Start Date
October 1 2014
End Date
August 1 2024
Last Update
October 4 2023
Active Locations (4)
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1
Matsuyama Red-Cross Hospital
Matsuyama, Ehime, Japan
2
Kyushu University Hospital
Fukuoka, Japan, 812-8582
3
Kyushu Central Hospital
Fukuoka, Japan, 815-8588
4
Morinomiya Hospital
Osaka, Japan, 536-0025