UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014926
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

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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 or person

Institute

Kyushu University

Institute

Department

Personal name



Funding Source

Organization

Japan Agency for Medical Research and Development
I'rom Group Co., Ltd.

Organization

Division

Category of Funding Organization

Other

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)、東京都済生会中央病院(東京都)、九州中央病院(福岡県)


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

27

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

No longer 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

2022 Year 11 Month 25 Day

Date of closure to data entry

2022 Year 11 Month 30 Day

Date trial data considered complete

2022 Year 12 Month 31 Day

Date analysis concluded

2023 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

2023 Year 02 Month 27 Day



Link to view the page

Value
https://center6.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