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Study of Subcutaneous Rehydration With Recombinant Human Hyaluronidase for Infants and Children (INFUSE-PR)

This study has been completed.

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




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