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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000014307
Receipt No. R000016659
Scientific Title Phase IIb double blinded parallel group dose response study for DVC1-0101 to treat severe intermittent claudication
Date of disclosure of the study information 2014/09/01
Last modified on 2014/06/18

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Basic information
Public title Phase IIb double blinded parallel group dose response study for DVC1-0101 to treat severe intermittent claudication
Acronym Phase IIb study of DVC1-0101
Scientific Title Phase IIb double blinded parallel group dose response study for DVC1-0101 to treat severe intermittent claudication
Scientific Title:Acronym Phase IIb study of DVC1-0101
Region
Japan

Condition
Condition PAD patients with severe intermittent claudication graded as Fontaine IIb and III
Classification by specialty
Vascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The primary objective of the study is to investigate the safety and clinical efficacy of DVC1-0101 (1x10e9 ciu/leg, 5x10e9 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 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes - Rate of increase in absolute claudication distance (ACD)
- ACD
- Peak walking time
- Initial claudication distance (ICD)
- Claudication onset time
Key secondary outcomes - 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 YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine Gene
Interventions/Control_1 Placebo (0ciu/leg)
Interventions/Control_2 Low dose (1x10e9 ciu/leg)
Interventions/Control_3 High dose (5x10e9 ciu/leg)
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
80 years-old >=
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 specialist qualified by the Japanese Association
of Cardiovascular Intervention and Therapeutics.
(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 40 years to 80 years.
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 concurrent cardiac failure (NYHA class II-IV)
7) With untreated severe arrhythmia
8) Have or are suspected to have interstitial pneumonia
9) Have progressive hepatic disorders
10) 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
11) Diagnosed with hepatic cirrhosis (classified as B or C on the Child-Pugh)
12) Have an inflammatory disease
13) Treated with immunosuppressants or corticosteroids for the treatment of various inflammatory diseases or after organ transplantation
14) Underwent extirpative surgery of a malignant tumor in the past 5 years
15) Have had a cerebral hemorrhage or cerebral infarction in the past 6 months
16) With blood diseases
17) With moderate or severe renal dysfunction (CCr < 40 mL/min)
18) With alcohol or drug dependence
19) Pregnant/lactating female, or who wish or are suspected to be pregnant
20) Positive HIV antibodies
21) Took part in any other clinical studies or research in the past 30 days
22) Not permitted to participate
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshihiko Maehara MD PhD FACS
Organization Kyushu University Hospital
Division name Vascular Surgery
Zip code
Address 3-1-1 Maidashi, Higashi-ku
TEL 092-642-5461
Email maehara@surg2.med.kyushu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takuya Matsumoto
Organization Kyushu University Hospital
Division name Vascular Surgery
Zip code
Address 3-1-1 Maidashi, Higashi-ku
TEL 092-642-5469
Homepage URL
Email takum@surg2.med.kyushu-u.ac.jp

Sponsor
Institute Kyushu University Hospital
Institute
Department

Funding Source
Organization Japanese Ministry of Health, Labor, and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 九州大学病院

Other administrative information
Date of disclosure of the study information
2014 Year 09 Month 01 Day

Related information
URL releasing protocol http://omicsgroup.org/journals/efficacy-and-safety-of-dvc-for-intermittent-claudication-secondary-to-peripheral-artery-disease-study-protocol-of-a-randomized-phase-iib-trial-2167-0870.1000138.php?aid=18026
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 Preinitiation
Date of protocol fixation
2013 Year 06 Month 20 Day
Date of IRB
Anticipated trial start date
2014 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 06 Month 18 Day
Last modified on
2014 Year 06 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016659

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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