Trials / Unknown
UnknownNCT02276937
Randomized Phase IIb Trial of DVC1-0101
DVC1-0101 for Intermittent Claudication Secondary to Peripheral Artery Disease: a Randomized Phase IIb Trial
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- Kyushu University · Academic / Other
- Sex
- All
- Age
- 30 Years
- Healthy volunteers
- Not accepted
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.
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2014-10-01
- Primary completion
- 2021-12-01
- Completion
- 2024-08-01
- First posted
- 2014-10-28
- Last updated
- 2023-10-04
Locations
4 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT02276937. Inclusion in this directory is not an endorsement.