Trial Outcomes & Findings for Safety and Efficacy Assessment of HAV in Patients Needing Vascular Access for Dialysis (NCT NCT04135417)

NCT ID: NCT04135417

Last Updated: 2024-03-19

Results Overview

Frequency and severity of AEs of each patient will be documented

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 30 participants
• Primary outcome timeframe: Up to 3 months post-implantation
• Results posted on: 2024-03-19

Participant Flow

Participant milestones

Measure	HAV (Continued in Description) 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. HAV: Surgical implantation of the HAV and subsequent use of the implanted vascular conduit for hemodialysis vascular access.
Overall Study STARTED	30
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Efficacy Assessment of HAV in Patients Needing Vascular Access for Dialysis

Baseline characteristics by cohort

Measure	HAV (Continued in Description) n=30 Participants 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. HAV: Surgical implantation of the HAV and subsequent use of the implanted vascular conduit for hemodialysis vascular access.
Age, Continuous	67.5 years n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	30 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	30 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Poland	30 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 3 months post-implantation

Frequency and severity of AEs of each patient will be documented

Outcome measures

Measure

HAV (Continued in Description) n=30 Participants 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. HAV: Surgical implantation of the HAV and subsequent use of the implanted vascular conduit for hemodialysis vascular access.

Cumulative Number of Subjects With Adverse Events Indicating Possible Mechanical Failure or Weakness of the HAV

0 participants

PRIMARY outcome

Timeframe: 2 months post implantation

Assess changes in the PRA response (number of participants) over the 2 months after graft implantation

Outcome measures

Measure

HAV (Continued in Description) n=30 Participants 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. HAV: Surgical implantation of the HAV and subsequent use of the implanted vascular conduit for hemodialysis vascular access.

Number of Participants With Baseline Change of Panel Reactive Antibody (PRA) Value

2 participants

PRIMARY outcome

Timeframe: Up to 3 months post-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.

Outcome measures

Measure	HAV (Continued in Description) n=30 Participants 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. HAV: Surgical implantation of the HAV and subsequent use of the implanted vascular conduit for hemodialysis vascular access.
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI) All AEs	12 participants
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI) All SAEs	7 participants
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI) All AESI	8 participants

PRIMARY outcome

Timeframe: 3 months post-implantation

Outcome measures

Measure	HAV (Continued in Description) n=30 Participants 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. HAV: Surgical implantation of the HAV and subsequent use of the implanted vascular conduit for hemodialysis vascular access.
Number of Participants With Primary Patency, Primary Assisted Patency and Secondary Patency Loss of primary patency at Month 3	1 participants
Number of Participants With Primary Patency, Primary Assisted Patency and Secondary Patency Loss of primary assisted patency at Month 3	1 participants
Number of Participants With Primary Patency, Primary Assisted Patency and Secondary Patency Loss of secondary patency at Month 3	0 participants

SECONDARY outcome

Timeframe: 12 months post-implantation

Population: In total, 4 subjects (13%) had an increase in PRA levels from Baseline that remained elevated through Month 12.

Assess changes in the PRA response (number of subjects) over the 12 months after graft implantation

Outcome measures

Measure

HAV (Continued in Description) n=30 Participants 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. HAV: Surgical implantation of the HAV and subsequent use of the implanted vascular conduit for hemodialysis vascular access.

Number of Participants With Baseline Change of Panel Reactive Antibody (PRA) Value

4 participants

SECONDARY outcome

Timeframe: Up to 12 months post-implantation

Frequency and severity of AEs/SAE of each patient will be documented

Outcome measures

Measure	HAV (Continued in Description) n=30 Participants 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. HAV: Surgical implantation of the HAV and subsequent use of the implanted vascular conduit for hemodialysis vascular access.
Number of Participants With All AEs/SAEs Number of Participants with All AEs	25 Participants
Number of Participants With All AEs/SAEs Number of Participants with All SAEs	19 Participants

Adverse Events

HAV (Continued in Description)

Serious events: 19 serious events

Other events: 10 other events

Deaths: 3 deaths

Serious adverse events

Measure	HAV (Continued in Description) n=30 participants at risk 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. HAV: Surgical implantation of the HAV and subsequent use of the implanted vascular conduit for hemodialysis vascular access.
Cardiac disorders Bradycardia, Cardiac failure	6.7% 2/30 • 24 months
Gastrointestinal disorders Gastritis	3.3% 1/30 • 24 months
Infections and infestations Bacterial sepsis, Bronchitis, C diff infection, Corona virus infection, continued in description	26.7% 8/30 • 24 months
Injury, poisoning and procedural complications Anatomic stenosis, Fall, Vascular access site hematoma, continued in description	40.0% 12/30 • 24 months
Nervous system disorders Ischemic stroke	3.3% 1/30 • 24 months
Vascular disorders Brachiocephalic vein stenosis	16.7% 5/30 • 24 months

Other adverse events

Measure	HAV (Continued in Description) n=30 participants at risk 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. HAV: Surgical implantation of the HAV and subsequent use of the implanted vascular conduit for hemodialysis vascular access.
Cardiac disorders Ventricular tachycardia	3.3% 1/30 • 24 months
Gastrointestinal disorders Haemorrhoids	3.3% 1/30 • 24 months
General disorders Implant site erythema	3.3% 1/30 • 24 months
Injury, poisoning and procedural complications Vascular access site haemorrhage	3.3% 1/30 • 24 months
Metabolism and nutrition disorders Hypercholesterolemia	3.3% 1/30 • 24 months
Musculoskeletal and connective tissue disorders Arthritis	3.3% 1/30 • 24 months
Vascular disorders Vascular stenosis	13.3% 4/30 • 24 months

Additional Information

Shamik Parikh, Chief Medical Officer

Humacyte Inc.

Phone: 919-313-9633

Email: sparikh@humacyte.com

Results disclosure agreements

• Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days from the time submitted to the sponsor for review. The sponsor can require changes to the communication and can extend the embargo.
• Publication restrictions are in place

Restriction type: OTHER