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

Tracking Information

First Received Date ^ICMJE

May 18, 2007

Last Updated Date

September 25, 2008

Start Date ^ICMJE

August 2007

Primary Completion Date

June 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Rehydration success rate (effectiveness) in children treated with HYLENEX-augmented fluid infusion

Change History

Complete list of historical versions of study NCT00477152 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Safety of HYLENEX-augmented fluid infusion in children

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Dehydration

Intervention ^ICMJE

Drug: hyaluronidase (human recombinant)/rehydration fluid

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

June 2008

Primary Completion Date

June 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

2 Months to 10 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00477152

Responsible Party

George E. Harb, MD, Baxter Healthcare Corporation

Study ID Numbers ^ICMJE

1838-003

Study Sponsor ^ICMJE

Baxter Healthcare Corporation

Collaborators ^ICMJE

Halozyme Therapeutics
PPD

Investigators ^ICMJE

Study Director:

George E Harb, MD

Baxter Healthcare Corporation

Information Provided By

Baxter Healthcare Corporation

Verification Date

September 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP