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HAVG

Phase 1

End-stage Renal Disease | Monoclonal antibody | Nephrology |Humacyte, Inc.|Last Updated: Aug 19, 2022

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment20
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01840956Safety and Efficacy of a Vascular Prosthesis for Hemodialysis Access in Patients With End-Stage Renal DiseasePHASE1 COMPLETED 20 — — May 23, 2013Apr 28, 2016Aug 19, 20223 United States
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Study Endpoints
Primary Endpoints
HAVG graft assessment
From baseline to week 26 after HAVG implantation.

The incidence of aneurysm formation, anastomotic bleeding or rupture, graft infection and irritation/inflammation/infection at the implantation site will be assessed by Doppler ultrasound and tabulated.

HAVG patency rate
at Week 26 after HAVG implantation

Determine the patency (primary, primary assisted and secondary) rate of the Humacyte HAVG by Doppler ultrasound.

Adverse Events
From baseline to week 26 after HAVG implantation.

Frequency and severity of AEs of each patient will be documented.

HAVG graft interventions
From baseline to week 26 after HAVG implantation.

Graft interventions of each patient will be documented.

Secondary Endpoints
Change from baseline in Panel Reactive Antibody
From baseline to day 29, weeks 12 and 26 after HAVG implantation.
Development of IgG antibodies
From baseline to day 29, weeks 12 and 26 after HAVG implantation.
Graft interventions
At each visit, i.e. day 1, day 4-7, day 15, day 29, day 57, week 12, week 16, 20, 26 after HAVG implantation.
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
HAVGEXPERIMENTALSurgical placement of HAVG
Interventions
NameTypeDescription
HAVGBIOLOGICALHAVG is implanted into patients' arm.
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Eligibility Criteria
Age Range18 Years — 80 Years
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Patients 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 upper extremity to start or maintain hemodialysis therapy * Age 18 to 80 years old, inclusive * Suitable anatomy for impl...

Countries:United States
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