UMIN-CTR Clinical Trial

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

PAD patients with severe intermittent claudication graded as Fontaine IIb and III

Classification by specialty

Vascular surgery

Classification by malignancy

Others

Genomic information

NO

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

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)

Study type

Interventional

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

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

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

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

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

Institute

Kyushu University Hospital

Institute

Department

Personal name

Organization

Japanese Ministry of Health, Labor, and Welfare

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

九州大学病院

Date of disclosure of the study information

2014

Year

09

Month

01

Day

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

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

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 related information

Registered date

2014

Year

06

Month

18

Day

Last modified on

2014

Year

06

Month

18

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016659