MedTrace Logo

Study of Subcutaneous Rehydration With Recombinant Human Hyaluronidase for Infants and Children

NCT00477152 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2011-12-01

Study results available
· View outcomes & findings →

Summary

The aim of the study is to evaluate the safety, effectiveness and ease of use of subcutaneous (SC) rehydration using HYLENEX-augmented SC infusion of fluids and electrolytes for the rehydration of pediatric patients with mild to moderate dehydration.

Conditions

Interventions

DRUG

hyaluronidase (human recombinant)/rehydration fluid

Single 150 U subcutaneous (SC) HYLENEX dose administered immediately prior to start of SC infusion of rehydration fluid. Additional 150 U HYLENEX dose to be administered prior to any additional fluid infusion beyond 24 hours.

Sponsors & Collaborators

  • Halozyme Therapeutics

    collaborator INDUSTRY

  • PPD Development, LP

    collaborator INDUSTRY

  • Baxter Healthcare Corporation

    lead INDUSTRY

Principal Investigators

  • George E Harb, MD · Baxter Healthcare Corporation

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Months
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2008-06-30
Completion
2008-06-30

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00477152 on ClinicalTrials.gov