NCT02276937

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 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2014

Longer than P75 for phase_2

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

October 22, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 28, 2014

Completed
7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

October 4, 2023

Status Verified

October 1, 2023

Enrollment Period

7.2 years

First QC Date

October 22, 2014

Last Update Submit

October 3, 2023

Conditions

Intermittent ClaudicationPeripheral Arterial Disease

Keywords

Recombinant Sendai virusfibroblast growth factor-2treadmill

Outcome Measures

Primary Outcomes (1)

  • 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

    6 months

Secondary Outcomes (7)

  • NIRS measurement

    Pre, day 14, 1, 2, 3, 4, 5, and 6 months

  • Readministration

    6 months

  • WIQ

    Pre, 1, 3, and 6 months

  • Clinical stage classifications

    Pre, day 14, 1, 2, 3, 4, 5, and 6 months

  • ABI/TBI

    Pre, day 14, 1, 3, and 6 months

  • +2 more secondary outcomes

Study Arms (3)

Placebo (0 ciu/limb)

PLACEBO COMPARATOR

Placebo control

Drug: DVC1-0101

DVC1-0101 low dose (1x10^9 ciu/limb)

ACTIVE COMPARATOR

Low dose cohort

Drug: DVC1-0101

DVC1-0101 high dose (5x10^9 ciu/limb)

ACTIVE COMPARATOR

High dose cohort

Drug: DVC1-0101

Interventions

DVC1-0101DRUG

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.

Also known as: rSeV/dF expressing human FGF-2 gene
DVC1-0101 high dose (5x10^9 ciu/limb)DVC1-0101 low dose (1x10^9 ciu/limb)Placebo (0 ciu/limb)

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.
  • 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.
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Matsuyama Red-Cross Hospital

Matsuyama, Ehime, Japan

Location

Kyushu University Hospital

Fukuoka, 812-8582, Japan

Location

Kyushu Central Hospital

Fukuoka, 815-8588, Japan

Location

Morinomiya Hospital

Osaka, 536-0025, Japan

Location

Related Publications (2)

  • 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.

    PMID: 23319060BACKGROUND

  • 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.

    PMID: 27418463BACKGROUND

MeSH Terms

Conditions

Intermittent ClaudicationPeripheral Arterial Disease

Condition Hierarchy (Ancestors)

Peripheral Vascular DiseasesVascular DiseasesCardiovascular DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsAtherosclerosisArteriosclerosisArterial Occlusive Diseases

Study Officials

  • Yoshikazu Yonemitsu

    Kyushu University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 22, 2014

First Posted

October 28, 2014

Study Start

October 1, 2014

Primary Completion

December 1, 2021

Study Completion

August 1, 2024

Last Updated

October 4, 2023

Record last verified: 2023-10

Locations

JP(4)