Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
HAV · 1 trial · 4 indications
Frequency and severity of AEs of each patient will be documented
Assess changes in the PRA response (number of participants) over the 2 months after graft implantation
Frequency and severity of all adverse events (AEs), serious adverse events (SAEs) and adverse events of special interest (AESI) of each patient will be documented.
| Arm | Type | Description |
|---|---|---|
| HAV | EXPERIMENTAL | The HAV is a tissue-engineered vascular conduit (6mm diameter) for hemodialysis access in patients with end-stage renal disease. HAV for this study will be manufactured using the commercial manufacturing system.It will be implanted in the forearm or upper arm using standard vascular surgical techniques. All subjects will be required to start taking daily aspirin (75 or 325 mg) on Day 1 after surgical implantation of HAV unless they are already taking another antiplatelet agent. If low molecular weight heparin (LMWH) is administered post-operatively, aspirin or other antiplatelet agents should be initiated after stopping LMWH. Subjects who are known to be aspirin-sensitive should take another antiplatelet agent at the discretion of the Principal Investigator. |
| Name | Type | Description |
|---|---|---|
| HAV | BIOLOGICAL | Surgical implantation of the HAV and subsequent use of the implanted vascular conduit for hemodialysis vascular access. |
Inclusion Criteria: 1. Subjects with ESRD who are not, or who are no longer candidates for creation of an autologous AV fistula and therefore need placement of an AV graft in the arm (upper or forearm) for hemodialysis therapy. 2. Already established on hemodialysis 3. At least 18 years of age at S...
HAV is an investigational therapy being studied for use in patients with renal failure, including end stage renal disease, who need vascular access for hemodialysis. It is being developed by Humacyte, Inc. (NASDAQ: HUMA) and is currently in Phase 2 clinical development.
HAV is a monoclonal antibody, but its specific molecular target has not been disclosed. The therapy is being evaluated for its safety and efficacy in providing vascular access for dialysis in patients with renal failure.
HAV is being developed by Humacyte, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol HUMA. Humacyte is conducting clinical research to assess the therapy's potential in patients needing vascular access for dialysis.
HAV is in Phase 2 clinical development. It has completed a Phase 2 trial, and it is not yet approved by the FDA. The therapy has received FDA designations including Regenerative Medicine Advanced Therapy (RMAT), Fast Track, and Priority Review.
HAV has been studied in a completed Phase 2 clinical trial with the identifier NCT04135417. The trial, titled 'Safety and Efficacy Assessment of HAV in Patients Needing Vascular Access for Dialysis,' enrolled 30 patients in Poland with renal failure, end stage renal disease, and vascular access needs.
HAV is the investigational therapy developed by Humacyte, Inc. for vascular access in dialysis patients. It is a monoclonal antibody being evaluated for safety and efficacy in this setting, and it is distinct from other products in Humacyte's pipeline.