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Randomized Phase IIb Trial of DVC1-0101

NCT02276937 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-10-04

No results posted yet for this study

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.

Conditions

  • Intermittent Claudication
  • Peripheral Arterial Disease

Interventions

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.

Sponsors & Collaborators

  • Ministry of Health, Labour and Welfare, Japan

    collaborator OTHER_GOV

  • Japan Agency for Medical Research and Development

    collaborator OTHER_GOV

  • Kyushu University

    lead OTHER

Principal Investigators

  • Yoshikazu Yonemitsu · Kyushu University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2021-12-31
Completion
2024-08-31

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02276937 on ClinicalTrials.gov