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HAVG

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment20

FDA Designations

PRIORITY_REVIEW

Clinical trial landscape

HAVG · 1 trial · 2 indications

Phase 1 1
NCT01840956Safety and Efficacy of a Vascular Prosthesis for Hemodialysis Access in Patients With End-Stage Renal DiseaseEnd-stage Renal Disease
COMPLETED20 Analytics
PHASE1COMPLETED
Safety and Efficacy of a Vascular Prosthesis for Hemodialysis Access in Patients With End-Stage Renal Disease
End-stage Renal Disease
NCT0184095620
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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 to 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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Frequently asked questions about HAVG

What is HAVG used for in End-Stage Renal Disease?

HAVG is an investigational monoclonal antibody being developed for patients with End-Stage Renal Disease. It is being studied as a vascular prosthesis for hemodialysis access in patients with this condition, according to a completed Phase 1 clinical trial.

What does HAVG target?

HAVG is a monoclonal antibody, but its specific molecular target has not been disclosed. The drug is being investigated for use as a vascular prosthesis to provide hemodialysis access in patients with End-Stage Renal Disease.

Who makes HAVG?

HAVG is being developed by Humacyte, Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol HUMA. The company is conducting clinical research on this investigational therapy for End-Stage Renal Disease.

What phase is HAVG in?

HAVG is in Phase 1 clinical development. A Phase 1 trial has been completed, and the drug remains investigational. It has not been approved by the FDA and is still undergoing clinical evaluation for End-Stage Renal Disease.

What clinical trials is HAVG in?

HAVG has one completed clinical trial registered as NCT01840956, titled 'Safety and Efficacy of a Vascular Prosthesis for Hemodialysis Access in Patients With End-Stage Renal Disease.' This Phase 1 study enrolled 20 participants in the United States and was not randomized or blinded.

Is HAVG FDA approved?

HAVG is not FDA approved. It is an investigational drug that has received Priority Review designation from the FDA, but it remains in clinical development. A Phase 1 trial has been completed, and the drug is still being studied for End-Stage Renal Disease.