Intermittent ClaudicationPhase 2NCT02276937

Randomized Phase IIb Trial of DVC1-0101

A Phase 2 study testing DVC1-0101 in people with Intermittent Claudication and Peripheral Arterial Disease, run by Kyushu University at 4 sites in Japan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 30 years and older
Conditions the study is for: Intermittent Claudication, Peripheral Arterial Disease
What is being tested?: DVC1-0101
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 30 participants
Where: 4 sitesJapan
Study dates: Oct 2014to Aug 2024
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 30 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.
arteriosclerosis obliterans with stable symptoms, have intermittent claudication (ACD < 260 m) and are able to walk on a treadmill
resting ankle-brachial pressure index < 0.9
refuse revascularization, risk of revascularization may be greater than the benefit, or develop obliteration after revascularization
angiographic findings show patency from the abdominal aorta through to the proximal side of the external iliac artery
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

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2) Administering cilostazol for at least 1 month and still meet criterion 1).
3) Aged 30 and over.
4) Either sex, either inpatients or outpatients.
5) Able to give written consent for themselves.

Who cannot join

Have ischemic ulcer.
Diagnosed with Buerger's disease.
Have a current or past history of life-threatening allergies.
Have been shown or are suspected to have cancer.
With concurrent proliferative intraocular neovascularization.
With poorly controlled diabetes mellitus.

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With concurrent cardiac failure.
With untreated severe arrhythmia.
Have or are suspected to have interstitial pneumonia.
Have progressive hepatic disorders.
Have moderate or severe hepatic disorders. (1) aspartate aminotransferase or alanine aminotransferase >2.5 times the upper limit (2) Prothrombin time is 14 seconds or longer (3) Serum bilirubin >2.0 times the upper limit
Diagnosed with hepatic cirrhosis (classified as B or C on the Child-Pugh).
Have an inflammatory disease.
Treated with immunosuppressants or corticosteroids for the treatment of various inflammatory diseases or after organ transplantation.
Underwent extirpative surgery of a malignant tumor in the past 5 years.
Have had a cerebral hemorrhage or cerebral infarction in the past 6 months.
With blood diseases.
With moderate or severe renal dysfunction (CCr <40 mL/min)
With alcohol or drug dependence.
Pregnant/lactating female, or who wish or are suspected to be pregnant.
Positive HIV antibodies.
Took part in any other clinical studies or research in the past 30 days.
Have allergic to the antibiotics and/or the Ribavirin.
Not permitted to participate in this study by the principal investigator or sub-investigator for any other reasons.

Trial locations and contacts

4 sites in 1 country.

Japan4 sites

Kyushu University Hospital
Fukuoka, 812-8582
Kyushu Central Hospital
Fukuoka, 815-8588
Matsuyama Red-Cross Hospital
Matsuyama, Ehime
Morinomiya Hospital
Osaka, 536-0025

Other trials in Japan

About this study

Official title: DVC1-0101 for Intermittent Claudication Secondary to Peripheral Artery Disease: a Randomized Phase IIb Trial

The primary objective of the current Phase IIb study is to investigate the clinical efficacy of DVC1-0101 (1x10^9 ciu/leg, 5x10^9 ciu/leg) in patients with IC.

Read the detailed description

DVC1-0101 is a gene therapy medicine to treat peripheral arterial disease (PAD) based on recombinant F-gene-deleted, non-transmissible Sendai virus (rSeV/dF) expressing human fibroblast growth factor-2 (FGF-2) gene. The previous Phase I/IIa study demonstrated no serious adverse event related to the administration, and suggested possible improvement of local blood flow and walking performance of PAD patients.

The primary objective of the current Phase IIb 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.

Conditions: Intermittent Claudication, Peripheral Arterial Disease
Being tested: DVC1-0101
Keywords: Recombinant Sendai virus, fibroblast growth factor-2, treadmill
Medical subject headings: Intermittent Claudication, Peripheral Arterial Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DVC1-0101Drug
Also called rSeV/dF expressing human FGF-2 gene
The investigational product will be drawn into a disposable 1 mL syringe using a 23G needle. A total of 0.5 mL of investigational product will be injected intramuscularly into each administration site. After administration, the administration sites will be wrapped with dressings.

Study groups in NCT02276937
Study group	Role	What they receive
Placebo (0 ciu/limb)	Placebo comparator	Placebo control Receives: Drug: DVC1-0101
DVC1-0101 low dose (1x10^9 ciu/limb)	Active comparator	Low dose cohort Receives: Drug: DVC1-0101
DVC1-0101 high dose (5x10^9 ciu/limb)	Active comparator	High dose cohort Receives: Drug: DVC1-0101

What is being measured

The primary outcome is the main question the study is designed to answer.

Walking performance assessed by treadmill utilizing Gardner's method
Change rate from baseline in absolute claudication distance (%ACD) at 6 months Change of ACD from baseline at 6 months Change of peak walking time from baseline at 6 months Change of initial claudication distance (ICD) from baseline at 6 months Change of claudication onset time from baseline at 6 months
Measured: 6 months

Secondary outcomes (7)

NIRS measurement
Measurement of oxygen dynamics in the leg muscles by near infrared spectroscopy after a treadmill
Measured: Pre, day 14, 1, 2, 3, 4, 5, and 6 months
Readministration
Proportion of subjects in whom readministration was not required
Measured: 6 months
WIQ
Evaluation of QOL based on the Walking Impairment Questionnaire (WIQ)
Measured: Pre, 1, 3, and 6 months
Clinical stage classifications
Time-course changes using clinical stage classifications (Fontaine classification, Rutherford classification)
Measured: Pre, day 14, 1, 2, 3, 4, 5, and 6 months
ABI/TBI
Ankle-brachial pressure index/ Toe-brachial pressure index
Measured: Pre, day 14, 1, 3, and 6 months
VAS
visual analogue scale (VAS) and pain at rest evaluated by the frequency of analgesic use
Measured: Pre, day 1, 2, 3, 5, 7, 14 and monthly until 6 months
MACE
Incidence of cardiovascular events (to be followed up to 5 years after administration)
Measured: Monthly until 1 year after gene transfer

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2014Aug 2024

First posted28 Oct 2014 (estimated)
Study startOct 2014
Primary completionDec 2021
Study completionAug 2024 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Intermittent ClaudicationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 30 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02276937
Sponsor's protocol ID: CTR-001
Other IDs: UMIN000014926
Status last verified: Oct 2023
First submitted: 22 Oct 2014
Last updated: 4 Oct 2023
Results posted: No
Data monitoring committee: Yes

Publications

Yonemitsu Y, Matsumoto T, Itoh H, Okazaki J, Uchiyama M, Yoshida K, Onimaru M, Onohara T, Inoguchi H, Kyuragi R, Shimokawa M, Ban H, Tanaka M, Inoue M, Shu T, Hasegawa M, Nakanishi Y, Maehara Y. DVC1-0101 to treat peripheral arterial disease: a Phase I/IIa open-label dose-escalation clinical trial. Mol Ther. 2013 Mar;21(3):707-14. doi: 10.1038/mt.2012.279. Epub 2013 Jan 15.
PubMed 23319060
Matsumoto T, Tanaka M, Yoshiya K, Yoshiga R, Matsubara Y, Horiuchi-Yoshida K, Yonemitsu Y, Maehara Y. Improved quality of life in patients with no-option critical limb ischemia undergoing gene therapy with DVC1-0101. Sci Rep. 2016 Jul 15;6:30035. doi: 10.1038/srep30035.
PubMed 27418463

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
EVERO Drug-coated Balloon (DCB) Randomized Trial
Peripheral Vascular Disease, Peripheral Arterial Disease
Recruiting
Personalised Multicomponent Exercise Programme in Peripheral Arterial Disease
Peripheral Arterial Disease, Intermittent Claudication
Active, not recruitingPhase 4
Ramipril Treatment of Claudication: Oxidative Damage and Muscle Fibrosis
Peripheral Arterial Disease
RecruitingPhase 3
Improving Mobility After Revascularization in Peripheral Artery Disease
Peripheral Artery Disease, Intermittent Claudication
Recruiting
Passive Calf Stretching Therapy in Peripheral Artery Disease
Peripheral Artery Disease, Claudication, Intermittent

All Intermittent Claudication trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: DVC1-0101 for Intermittent Claudication Secondary to Peripheral Artery Disease: a Randomized Phase IIb Trial
ClinicalTrials.gov ID: NCT02276937
Acronym / sponsor ID: CTR-001
Conditions: Intermittent Claudication, Peripheral Arterial Disease
Keywords: Recombinant Sendai virus, fibroblast growth factor-2, treadmill
Phase: Phase 2
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 30 participants (estimated)
Lead sponsor: Kyushu UniversityUniversity, hospital or other
Collaborators: Ministry of Health, Labour and Welfare, Japan, Japan Agency for Medical Research and Development
Study start: Oct 2014 (actual)
Primary completion: Dec 2021 (actual)
Study completion: Aug 2024 (estimated)
First posted: 28 Oct 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The primary objective of the current Phase IIb study is to investigate the clinical efficacy of DVC1-0101 (1x10^9 ciu/leg, 5x10^9 ciu/leg) in patients with IC.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Placebo (0 ciu/limb)	Placebo comparator	Drug: DVC1-0101Placebo control
DVC1-0101 low dose (1x10^9 ciu/limb)	Active comparator	Drug: DVC1-0101Low dose cohort
DVC1-0101 high dose (5x10^9 ciu/limb)	Active comparator	Drug: DVC1-0101High dose cohort

Who may qualify

Ages: 30 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

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.
arteriosclerosis obliterans with stable symptoms, have intermittent claudication (ACD < 260 m) and are able to walk on a treadmill
resting ankle-brachial pressure index < 0.9
refuse revascularization, risk of revascularization may be greater than the benefit, or develop obliteration after revascularization
angiographic findings show patency from the abdominal aorta through to the proximal side of the external iliac artery

Key exclusion criteria (24 listed)

Have ischemic ulcer.
Diagnosed with Buerger's disease.
Have a current or past history of life-threatening allergies.
Have been shown or are suspected to have cancer.
With concurrent proliferative intraocular neovascularization.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DVC1-0101Also: rSeV/dF expressing human FGF-2 geneThe investigational product will be drawn into a disposable 1 mL syringe using a 23G needle. A total of 0.5 mL of investigational product will be injected intramuscularly into each administration site. After administration, the administration sites will be wrapped with dressings.	Drug	DVC1-0101 high dose (5x10^9 ciu/limb), DVC1-0101 low dose (1x10^9 ciu/limb), Placebo (0 ciu/limb)

Primary outcome

Walking performance assessed by treadmill utilizing Gardner's method
Time frame: 6 months
Change rate from baseline in absolute claudication distance (%ACD) at 6 months Change of ACD from baseline at 6 months Change of peak walking time from baseline at 6 months Change of initial claudication distance (ICD) from baseline at 6 months Change of claudication onset time from baseline at 6 months

7 secondary outcomes

NIRS measurement
Time frame: Pre, day 14, 1, 2, 3, 4, 5, and 6 months
Readministration
Time frame: 6 months
WIQ
Time frame: Pre, 1, 3, and 6 months
Clinical stage classifications
Time frame: Pre, day 14, 1, 2, 3, 4, 5, and 6 months
ABI/TBI
Time frame: Pre, day 14, 1, 3, and 6 months
VAS
Time frame: Pre, day 1, 2, 3, 5, 7, 14 and monthly until 6 months
MACE
Time frame: Monthly until 1 year after gene transfer

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2023.
Background: PubMed 23319060Yonemitsu Y, Matsumoto T, Itoh H, Okazaki J, Uchiyama M, Yoshida K, Onimaru M, Onohara T, Inoguchi H, Kyuragi R, Shimokawa M, Ban H, Tanaka M, Inoue M, Shu T, Hasegawa M, Nakanishi Y, Maehara Y. DVC1-0101 to treat peripheral arterial disease: a Phase I/IIa open-label dose-escalation clinical trial. Mol Ther. 2013 Mar;21(3):707-14. doi: 10.1038/mt.2012.279. Epub 2013 Jan 15.
Background: PubMed 27418463Matsumoto T, Tanaka M, Yoshiya K, Yoshiga R, Matsubara Y, Horiuchi-Yoshida K, Yonemitsu Y, Maehara Y. Improved quality of life in patients with no-option critical limb ischemia undergoing gene therapy with DVC1-0101. Sci Rep. 2016 Jul 15;6:30035. doi: 10.1038/srep30035.

Related trials for Intermittent Claudication

Recruiting
EVERO Drug-coated Balloon (DCB) Randomized Trial
Peripheral Vascular Disease, Peripheral Arterial Disease
Recruiting
Personalised Multicomponent Exercise Programme in Peripheral Arterial Disease
Peripheral Arterial Disease, Intermittent Claudication
Active, not recruitingPhase 4
Ramipril Treatment of Claudication: Oxidative Damage and Muscle Fibrosis
Peripheral Arterial Disease
RecruitingPhase 3
Improving Mobility After Revascularization in Peripheral Artery Disease
Peripheral Artery Disease, Intermittent Claudication
Recruiting
Passive Calf Stretching Therapy in Peripheral Artery Disease
Peripheral Artery Disease, Claudication, Intermittent

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Yoshikazu Yonemitsu study chair

Kyushu University

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing DVC1-0101 in people with Intermittent Claudication and Peripheral Arterial Disease, run by Kyushu University at 4 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 4 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Walking performance assessed by treadmill utilizing Gardner's method (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02276937, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2023.