Study of Subcutaneous Rehydration With Recombinant Human Hyaluronidase for Infants and Children - Full Text View

Purpose

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

Condition	Intervention	Phase
Dehydration	Drug: hyaluronidase (human recombinant)/rehydration fluid	Phase IV

ChemIDplus related topics:

Hyaluronate Sodium Hyaluronic acid Hyaluronidase

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Official Title:	INcreased Flow Utilizing Subcutaneously-Enabled Pediatric Rehydration (INFUSE-Pediatric Rehydration Study): Phase IV Study of Subcutaneous Rehydration With Recombinant Human Hyaluronidase (HYLENEX) for Infants and Children

Further study details as provided by Baxter Healthcare Corporation:

Primary Outcome Measures:

Rehydration success rate (effectiveness) in children treated with HYLENEX-augmented fluid infusion [ Time Frame: 1-3 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety of HYLENEX-augmented fluid infusion in children [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]

Enrollment:	51
Study Start Date:	August 2007
Study Completion Date:	June 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
HYLENEX-augmented SC rehydration: Experimental	Drug: hyaluronidase (human recombinant)/rehydration fluid single 150 U SC dose administered immediately prior to start of SC infusion of rehydration fluid

Eligibility

Ages Eligible for Study:	2 Months to 10 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Child, 2 months to 10 years of age
Body weight less than 42 kg
Presenting at emergency department with mild to moderate dehydration requiring parenteral rehydration

Exclusion Criteria:

In shock or life-threatening situation (other than dehydration)
Severe dehydration
Requires IV therapy for another indication
Indwelling IV catheter (excepting one intended strictly for clinical laboratory sample collection)
Already received rehydration therapy IV within prior 48 hours or substantial oral fluid immediately before enrollment
Condition precluding subcutaneous injection or infusion site evaluation in anterior thigh or other elected infusion site
Reason for hospital admission or extended ED stay other than dehydration
Known hypersensitivity to hyaluronidase or another ingredient in HYLENEX
Hyponatremia or hypernatremia
Hypokalemia
Medical condition likely to interfere with ability to fully complete study or have protocol-specified assessments
Medical history, screening examination finding or historical clinical laboratory result precluding safe participation in study or which might adversely effect interpretation of study results
Participated in study of any investigational drug or device within 30 days prior to this study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00477152

Sponsors and Collaborators

Baxter Healthcare Corporation

Halozyme Therapeutics

PPD

Investigators


Study Director:	George E Harb, MD	Baxter Healthcare Corporation

More Information

Responsible Party:	Baxter Healthcare Corporation ( George E. Harb, MD )
Study ID Numbers:	1838-003
First Received:	May 18, 2007
Last Updated:	September 25, 2008
ClinicalTrials.gov Identifier:	NCT00477152
Health Authority:	United States: Food and Drug Administration

Keywords provided by Baxter Healthcare Corporation:

dehydration

fluid therapy

pediatrics

emergency medicine

hyaluronoglucosaminidase

hyaluronidase

hypodermoclysis

clysis

subcutaneous hydration

subcutaneous rehydration

hyaluronan

rHuPH20

Study placed in the following topic categories:

Metabolic Diseases

Hyaluronic Acid

Emergencies

Water-Electrolyte Imbalance

Metabolic disorder

Dehydration

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on October 10, 2008

Sponsors and Collaborators:	Baxter Healthcare Corporation Halozyme Therapeutics PPD
Information provided by:	Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:	NCT00477152