NCT04135417Phase 2Completed

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

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2021-05-15Actual

Enrollment · participants30Actual

Source updated2024-03-19Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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No recorded changes are available for this view and time period. Our history may be incomplete; this does not establish that the trial stayed unchanged.

Study details

Conditions studied

Renal Failure; End Stage Renal Disease; Vascular Access; Hemodialysis

Treatments or interventions studied

HAVBiological

Primary outcomes · main study measures

Read the study measures

measure: Cumulative Number of Subjects With Adverse Events Indicating Possible Mechanical Failure or Weakness of the HAV; description: Frequency and severity of AEs of each patient will be documented; timeFrame: Up to 3 months post-implantation; measure: Number of Participants With Baseline Change of Panel Reactive Antibody (PRA) Value; description: Assess changes in the PRA response (number of participants) over the 2 months after graft implantation; timeFrame: 2 months post implantation; measure: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI); description: 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.; timeFrame: Up to 3 months post-implantation; measure: Number of Participants With Primary Patency, Primary Assisted Patency and Secondary Patency; timeFrame: 3 months post-implantation

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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