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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000014926
Receipt No. 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 2019/12/20

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Basic information
Public title DVC1-0101 for Intermittent Claudication Secondary to Peripheral Artery Disease: a Randomized Phase IIb Trial
Acronym Randomized Phase IIb Trial of DVC1-0101
Scientific Title DVC1-0101 for Intermittent Claudication Secondary to Peripheral Artery Disease: a Randomized Phase IIb Trial
Scientific Title:Acronym Randomized Phase IIb Trial of DVC1-0101
Region
Japan

Condition
Condition Severe Intermittent Claudication (IC) Secondary to Peripheral Artery Disease
Classification by specialty
Cardiology Vascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 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.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes 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
Key secondary outcomes 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)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment Central registration

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine Gene
Interventions/Control_1 Placebo (0 ciu/limb), single intramuscular injection
Interventions/Control_2 DVC1-0101 low dose (1x10^9 ciu/limb), single intramuscular injection
Interventions/Control_3 DVC1-0101 high dose (5x10^9 ciu/limb), single intramuscular injection
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
30 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 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.
Key exclusion criteria 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.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshikazu Yonemitsu MD PhD FAHA
Organization Kyushu University
Division name R&D Laboratory for Innovative Biotherapeutics, Graduate School of Pharmaceutical Sciences
Zip code 812-8582
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka
TEL 092-642-6337
Email yonemitu@med.kyushu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshikazu Yonemitsu MD PhD FAHA
Organization Kyushu University
Division name R&D Laboratory for Innovative Biotherapeutics, Graduate School of Pharmaceutical Sciences
Zip code 812-8582
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka
TEL 092-642-6337
Homepage URL
Email yonemitu@med.kyushu-u.ac.jp

Sponsor
Institute Kyushu University
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization JAPAN

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

IRB Contact (For public release)
Organization Kyushu University Institutional Review Board
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka
Tel 092-642-5774
Email bysirb@jimu.kyushu-u.ac.jp

Secondary IDs
Secondary IDs YES
Study ID_1 NCT02276937
Org. issuing International ID_1 U.S. National Institutes of Health
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 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)

Other administrative information
Date of disclosure of the study information
2014 Year 09 Month 01 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
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 Open public recruiting
Date of protocol fixation
2014 Year 08 Month 25 Day
Date of IRB
2013 Year 11 Month 26 Day
Anticipated trial start date
2014 Year 10 Month 01 Day
Last follow-up date
2021 Year 08 Month 25 Day
Date of closure to data entry
2021 Year 11 Month 30 Day
Date trial data considered complete
2021 Year 11 Month 30 Day
Date analysis concluded
2022 Year 02 Month 28 Day

Other
Other related information 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.

Management information
Registered date
2014 Year 08 Month 22 Day
Last modified on
2019 Year 12 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017367

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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