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Randomized Phase IIb Trial of DVC1-0101

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ClinicalTrials.gov Identifier: NCT02276937
Recruitment Status : Recruiting
First Posted : October 28, 2014
Last Update Posted : June 10, 2019
Sponsor:
Collaborators:
CPC Clinical Research (Collorado, USA)
Iberica Co. Ltd. (Fukuoka, Japan)
Ministry of Health, Labour and Welfare, Japan
Information provided by (Responsible Party):
Yoshikazu Yonemitsu, Kyushu University

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Intermittent Claudication Peripheral Arterial Disease Drug: DVC1-0101 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: DVC1-0101 for Intermittent Claudication Secondary to Peripheral Artery Disease: a Randomized Phase IIb Trial
Study Start Date : October 2014
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : February 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo (0 ciu/limb)
Placebo control
Drug: DVC1-0101
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.
Other Name: rSeV/dF expressing human FGF-2 gene

Active Comparator: DVC1-0101 low dose (1x10^9 ciu/limb)
Low dose cohort
Drug: DVC1-0101
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.
Other Name: rSeV/dF expressing human FGF-2 gene

Active Comparator: DVC1-0101 high dose (5x10^9 ciu/limb)
High dose cohort
Drug: DVC1-0101
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.
Other Name: rSeV/dF expressing human FGF-2 gene




Primary Outcome Measures :
  1. 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

  2. Walking performance assessed by treadmill utilizing Gardner's method [ Time Frame: 6 months ]
    Change of ACD from baseline at 6 months

  3. Walking performance assessed by treadmill utilizing Gardner's method [ Time Frame: 6 months ]
    Change of peak walking time from baseline at 6 months

  4. Walking performance assessed by treadmill utilizing Gardner's method [ Time Frame: 6 months ]
    Change of initial claudication distance (ICD) from baseline at 6 months

  5. Walking performance assessed by treadmill utilizing Gardner's method [ Time Frame: 6 months ]
    Change of claudication onset time from baseline at 6 months Change of claudication onset time from baseline


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


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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 < 260 m) and are able to walk on a treadmill
  2. resting ankle-brachial pressure index < 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 still meet criterion 1).

3) Aged 30 and over.

4) Either sex, either inpatients or outpatients.

5) Able to give written consent for themselves.

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) 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
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02276937


Contacts
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Contact: Yoshikazu Yonemitsu, MD PhD FAHA +81-92-642-6337 ext 6337 yonemitu@med.kyushu-u.ac.jp
Contact: Michiko Tanaka, RN PhD +81-92-642-6310 ext 6310 tmiciko@med.kyushu-u.ac.jp

Locations
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Japan
Matsuyama Red-Cross Hospital Recruiting
Matsuyama, Ehime, Japan
Contact: Terutoshi Yamaoka, MD, PhD         
Kyushu University Hospital Recruiting
Fukuoka, Japan, 812-8582
Contact: Yoshikazu Yonemitsu, MD PhD FAHA    +81-92-642-6337 ext 6337    yonemitu@med.kyushu-u.ac.jp   
Contact: Michiko Tanaka, RN PhD    +81-92-642-6310    tmiciko@med.kyushu-u.ac.jp   
Sponsors and Collaborators
Kyushu University
CPC Clinical Research (Collorado, USA)
Iberica Co. Ltd. (Fukuoka, Japan)
Ministry of Health, Labour and Welfare, Japan
Publications:
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Responsible Party: Yoshikazu Yonemitsu, Professor, Kyushu University
ClinicalTrials.gov Identifier: NCT02276937    
Other Study ID Numbers: CTR-001
UMIN000014926 ( Registry Identifier: UMIN CTR )
First Posted: October 28, 2014    Key Record Dates
Last Update Posted: June 10, 2019
Last Verified: June 2019
Keywords provided by Yoshikazu Yonemitsu, Kyushu University:
Recombinant Sendai virus
fibroblast growth factor-2
treadmill
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Intermittent Claudication
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases