Unique ID issued by UMIN | UMIN000014926 |
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Receipt number | R000017367 |
Scientific Title | DVC1-0101 for Intermittent Claudication Secondary to Peripheral Artery Disease: a Randomized Phase IIb Trial |
Date of disclosure of the study information | 2014/09/01 |
Last modified on | 2023/02/27 10:01:20 |
DVC1-0101 for Intermittent Claudication Secondary to Peripheral Artery Disease: a Randomized Phase IIb Trial
Randomized Phase IIb Trial of DVC1-0101
DVC1-0101 for Intermittent Claudication Secondary to Peripheral Artery Disease: a Randomized Phase IIb Trial
Randomized Phase IIb Trial of DVC1-0101
Japan |
Severe Intermittent Claudication (IC) Secondary to Peripheral Artery Disease
Cardiology | Vascular surgery |
Others
NO
The primary objective of the study is to investigate the clinical efficacy of DVC1-0101 (1x10^9 ciu/leg, 5x10^9 ciu/leg) in patients with IC. We also aim to examine the dose-response relationship using the rate of improvement in walking function as an indicator.
Safety,Efficacy
Exploratory
Explanatory
Phase II
Primary endpoints: at 6 months after gene transfer
- Rate of increase in absolute claudication distance (ACD)
- ACD
- Peak walking time
- Initial claudication distance (ICD)
- Claudication onset time
Secondary endpoints: at 6 months after gene transfer
- Measurement of oxygen dynamics in the leg muscles by near infrared spectroscopy after a treadmill load test
- Proportion of subjects in whom readministration was not required
- Evaluation of QOL based on the Walking Impairment
Questionnaire (WIQ)
- Time-course changes using clinical stage classifications
(Fontaine classification, Rutherford classification)
- Ankle-brachial pressure index
- Toe-brachial pressure index
- Time-course changes in pain at rest evaluated by the visual analogue scale
- Time-course changes in pain at rest evaluated by the frequency of analgesic use
- Incidence of cardiovascular events (to be followed up to 5 years after administration)
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
NO
NO
Central registration
3
Treatment
Medicine | Gene |
Placebo (0 ciu/limb), single intramuscular injection
DVC1-0101 low dose (1x10^9 ciu/limb), single intramuscular injection
DVC1-0101 high dose (5x10^9 ciu/limb), single intramuscular injection
30 | years-old | <= |
Not applicable |
Male and Female
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.
(1) arteriosclerosis obliterans with stable symptoms, have intermittent
claudication (ACD < 200 m) and are able to walk on a treadmill
(2) resting ABI < 0.9
(3) refuse revascularization, risk of revascularization may be greater than
the benefit, or develop obliteration after revascularization
(4) angiographic findings show patency from the abdominal aorta through
to the proximal side of the external iliac artery
(5) 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 meet criterion 1).
3) Aged 30 and over.
4) Either sex, either inpatients or outpatients.
5) Able to give written consent for themselves.
1) Have ischemic ulcer.
2) Diagnosed with Buerger's disease.
3) Have a current or past history of life-threatening allergies.
4) Have been shown or are suspected to have cancer.
5) With concurrent proliferative intraocular neovascularization.
6) With poorly controlled diabetes mellitus.
7) With concurrent cardiac failure.
8) With untreated severe arrhythmia.
9) Have or are suspected to have interstitial pneumonia.
10) Have progressive hepatic disorders.
11) Have moderate or severe hepatic disorders.
(1) AST or ALT >2.5 times the upper limit
(2) Prothrombin time is 14 seconds or longer
(3) Serum bilirubin >2.0 times the upper limit
12) Diagnosed with hepatic cirrhosis (classified as B or C on the Child-Pugh).
13) Have an inflammatory disease.
14) Treated with immunosuppressants or corticosteroids for the treatment of various inflammatory diseases or after organ transplantation.
15) Underwent extirpative surgery of a malignant tumor in the past 5 years.
16) Have had a cerebral hemorrhage or cerebral infarction in the past 6 months.
17) With blood diseases.
18) With moderate or severe renal dysfunction (CCr <40 mL/min)
19) With alcohol or drug dependence.
20) Pregnant/lactating female, or who wish or are suspected to be pregnant.
21) Positive HIV antibodies.
22) Took part in any other clinical studies or research in the past 30 days.
23) Have allergic to the antibiotics and/or the Ribavirin.
24) Not permitted to participate in this study by the principal investigator or sub-investigator for any other reasons.
30
1st name | |
Middle name | |
Last name | Yoshikazu Yonemitsu MD PhD FAHA |
Kyushu University
R&D Laboratory for Innovative Biotherapeutics, Graduate School of Pharmaceutical Sciences
812-8582
3-1-1 Maidashi, Higashi-ku, Fukuoka
092-642-6337
yonemitu@med.kyushu-u.ac.jp
1st name | |
Middle name | |
Last name | Yoshikazu Yonemitsu MD PhD FAHA |
Kyushu University
R&D Laboratory for Innovative Biotherapeutics, Graduate School of Pharmaceutical Sciences
812-8582
3-1-1 Maidashi, Higashi-ku, Fukuoka
092-642-6337
yonemitu@med.kyushu-u.ac.jp
Kyushu University
Japan Agency for Medical Research and Development
I'rom Group Co., Ltd.
Other
JAPAN
Kyushu University Institutional Review Board
3-1-1 Maidashi, Higashi-ku, Fukuoka
092-642-5774
bysirb@jimu.kyushu-u.ac.jp
YES
NCT02276937
U.S. National Institutes of Health
九州大学病院(福岡県)、松山赤十字病院(愛媛県)、森之宮病院(大阪府)、東京都済生会中央病院(東京都)、九州中央病院(福岡県)
2014 | Year | 09 | Month | 01 | Day |
Unpublished
27
No longer recruiting
2014 | Year | 08 | Month | 25 | Day |
2013 | Year | 11 | Month | 26 | Day |
2014 | Year | 10 | Month | 01 | Day |
2022 | Year | 11 | Month | 25 | Day |
2022 | Year | 11 | Month | 30 | Day |
2022 | Year | 12 | Month | 31 | Day |
2023 | Year | 02 | Month | 28 | Day |
Published study protocol:
Tanaka M, Matsumoto T, Morisaki K, Kyuragi R, Fujino Y, Yoshida K, Yonemitsu Y, Maehara Y.
Efficacy and Safety of DVC1-0101 for Intermittent Claudication Secondary to Peripheral Artery Disease: Study Protocol of a Randomized Phase IIb Trial.
Protocol: J Clin Trials 2013, 3: 138
doi: 10.4172/2167-0870.1000138
Result of Phase I/IIa trial:
Yonemitsu Y, Matsumoto T, Itoh H, Okazaki J, Uchiyama M, Yoshida K, Onimaru M, Onohara T, Inoguchi H, Kyuragi R, Guntani A, Shimokawa M, Ban H, Inoue M, Zhu T, Hasegawa M, Nakanishi Y, Maehara Y.
DVC1-0101 to treat peripheral arterial disease: Phase I/IIa, open-label, dose escalation clinical trial: Molecular Therapy 2013, 21:707-714.
2014 | Year | 08 | Month | 22 | Day |
2023 | Year | 02 | Month | 27 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017367
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