Overview

Phase III Study of Chondrocyte Alginate Gel Suspension in Pediatric Patients With Vesicoureteral Reflux

Status:
Unknown status

Trial end date:
1969-12-31

Target enrollment:

Participant gender:

Summary

OBJECTIVES: I. Determine the safety and efficacy of chondrocyte alginate gel suspension in pediatric patients with vesicoureteral reflux. II. Determine the long term efficacy of this treatment regimen in this patient population. III. Evaluate the short and long term avoidance of surgery or antibiotic therapy after this treatment regimen in this patient population. IV. Estimate the risk:benefit ratio of this treatment regimen in these patients.

Phase:

Phase 3

Details

Lead Sponsor:

FDA Office of Orphan Products Development

Collaborator:

Curis, Inc.

Treatments:

Alginic acid