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NCT03183245 (Biological- Human Acellular Vessel… in Hemodialysis): BVCT ex-ante prediction vs. reported outcome

On 14 Jul 2024, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 31 Jul 2024 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially sufficient.

Clinical Trial

NCTID
NCT03183245
Drug Name
Biological- Human Acellular Vessel (HAV) Procedure- Arteriovenous fistula (AVF)
Drug MoA
tissue-engineer acellular vascular conduit
Drug Modality
bioengineered acellular tissue (Device)
Drug Class
First-In-Class
Therapeutic Area
Renal Replacement Therapy
Indication
Hemodialysis
Human Patients
240
Sponsor
Humacyte
Phase
Phase 3

Prediction of , index 1677

Prospective Prediction
Prediction Index
1677
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient clinical benefit in patency/infection/aneurysm increasingly superior to AVF as time progresses)
Technical Prediction
SUCCESS (statistically significant clinical benefit in proportion of subjects with functional patency at month 6 non-inferior to AVF and proportion of subjects with secondary patency at month 12 superior to AVF)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
17 days in advance
Readout Data Interpretation
functional patency at month 6 and secondary patency at month 12 jointly superior to SoC AV fistula (p=0.0071).
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially sufficient
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official title
A Phase 3 Study to Compare the Efficacy and Safety of Humacyte's Human Acellular Vessel With That of an Autologous Arteriovenous Fistula in Subjects With End Stage Renal Disease
Phase
Phase 3
Status
Completed
Enrollment
242
Lead sponsor
Humacyte, Inc.
Conditions
Renal Failure; End Stage Renal Disease; Hemodialysis; Vascular Access
Interventions
BIOLOGICAL: Human Acellular Vessel (HAV); PROCEDURE: Arteriovenous fistula (AVF); OTHER: Hemodialysis
Design
Randomized · Parallel · None
Primary purpose
Treatment
Start
2017-09-29
Primary completion
2024-04-22
Completion
2025-06-19
Primary outcomes
  • Proportion of subjects with functional patency at 6 months post study access (SA) creation (6 months post SA creation)
  • Proportion of subjects with secondary patency of SA at 12 months post SA creation. (12 months post SA creation)

NCT03183245 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials