Trials / Active Not Recruiting
Active Not RecruitingNCT05837143
Myocardial Telomere Recapping Study for Dilated Cardiomyopathy
An Exploratory Clinical Study of JV001 in the Treatment of Patients With Heart Failure Due to Dilated Cardiomyopathy (Telomere Recapping to Restore Mitochondrial Biogenesis Study for Dilated Cardiomyopathy)
- Status
- Active Not Recruiting
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- Shanghai East Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The aim of this study is to determine the safety and feasibility of giving an adeno-associated viral vector expressing a modified telomerase protein (TERT), driven by cardiac troponin T promoter (AAV9-cTnT-modTERT), to 12 dilated cardiomyopathic patients.
Detailed description
It is an open-label, 6+6 design study involving two dosages ( 2×10\^11vg/kg, and 6×10\^11vg/kg) aimed to explore the safety, pharmacokinetics, immunology, and preliminary efficacy of JV001.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | JV001 | JV001 (AAV9/modTERT) will be delivered by a percutaneous method in the catheter laboratory. Dose: 2×10\^11vg/kg，or 6×10\^11vg/kg. |
Timeline
- Start date
- 2023-03-30
- Primary completion
- 2025-07-30
- Completion
- 2025-12-30
- First posted
- 2023-05-01
- Last updated
- 2024-07-16
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05837143. Inclusion in this directory is not an endorsement.