Trials / Completed
CompletedNCT04135417
Safety and Efficacy Assessment of HAV in Patients Needing Vascular Access for Dialysis
A Phase 2 Assessment of Humacyte's Human Acellular Vessel in Patients Needing Vascular Access for Dialysis
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- Humacyte, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a Phase 2, prospective, multicenter, open-label, single-arm study of the Human Acellular Vessel (HAV).
Detailed description
This is a Phase 2, prospective, multicenter, open-label, single-arm study. Subjects who sign informed consent would undergo study-specific screening assessments within 45 days from the day of informed consent. Eligible study subjects will receive a HAV and will be followed to 12 months post-implantation at routine study visits regardless of patency status. After 12 months, subjects with a patent HAV will be followed (while the HAV remains patent) for up to 2 years (24 months) post implantation at study visits every 6 months.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | HAV | Surgical implantation of the HAV and subsequent use of the implanted vascular conduit for hemodialysis vascular access. |
Timeline
- Start date
- 2019-11-12
- Primary completion
- 2021-05-15
- Completion
- 2022-03-02
- First posted
- 2019-10-22
- Last updated
- 2024-03-19
- Results posted
- 2024-02-23
Locations
2 sites across 1 country: Poland
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04135417. Inclusion in this directory is not an endorsement.