Subcutaneous Rehydration Compared to Intravenous Rehydration - Full Text View

Sponsors and Collaborators:	Halozyme Therapeutics Baxter Healthcare Corporation
Information provided by:	Halozyme Therapeutics
ClinicalTrials.gov Identifier:	NCT00773175

Purpose

Randomized (1:1 ratio) study of SC versus IV fluid rehydration in mildly to moderately dehydrated pediatric patients.

Condition	Intervention	Phase
Dehydration	Drug: recombinant human hyaluronidase	Phase IV

Drug Information available for: Hyaluronidase

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Subcutaneous Rehydration With Hylenex Compared to Intravenous Rehydration in Infants and Young Children With Mild to Moderate Dehydration

Further study details as provided by Halozyme Therapeutics:

Primary Outcome Measures:

Mean total volume of fluid administered at a single infusion site, from the start to the cessation of fluid administration. [ Time Frame: During the infusion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Proportion (%) of patients administered at least 200 mL total volume at a single infusion site, from the start to the cessation of fluid administration. [ Time Frame: During the infusion ] [ Designated as safety issue: No ]
Total volume administered at all infusion sites, from start to cessation of fluid administration for (1) the mean volume and (2) the proportion achieving > 200 mL. [ Time Frame: During the infusion ] [ Designated as safety issue: No ]
Mean maximum flow rate achieved (averaged over any 60 minute period of time). [ Time Frame: During the infusion ] [ Designated as safety issue: No ]
Proportion (%) of patients achieving a maximum flow rate (averaged over any 60 minute period of time) of > 2 mL/min. [ Time Frame: During the infusion ] [ Designated as safety issue: No ]
Safety and tolerability of infusion based on AEs, physical examinations including assessment of infusion sites, vital signs, and pain assessments (FLACC scoring). [ Time Frame: During the infusion ] [ Designated as safety issue: No ]

Estimated Enrollment:	186
Study Start Date:	October 2008
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Subcutaneous: Active Comparator Isotonic fluid rehydration by SC administration with hylenex (150 Units in 1 mL)	Drug: recombinant human hyaluronidase 150 Units in 1 mL
Intravenous: Active Comparator Isotonic fluid rehydration by IV	Drug: recombinant human hyaluronidase 150 Units in 1 mL

Detailed Description:

This is a prospective, randomized (1:1 ratio), open-label, parallel group, multicenter, multi-national, study of SC versus IV fluid rehydration in mildly to moderately dehydrated pediatric patients treated in the Emergency Department (ED), inpatient pediatric unit, and/or outpatient urgent care facility. It is expected that up to 186 patients, in order to achieve 148 evaluable patients, will be randomized in a 1:1 ratio to receive isotonic fluid rehydration by either SC administration with hylenex (150 Units) or IV without hylenex.

Eligibility

Ages Eligible for Study:	up to 3 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Children of either gender from one month to <3 years of age.
Patients with mild or moderate dehydration
Healthy child except for the underlying etiology for dehydration
Pre-dehydration body weight ≥ 5th percentile for age
Parents or legal guardian(s) available to provide informed consent.

Exclusion Criteria:

Severe dehydration
Shock or life-threatening situation (life expectancy < 10 days).
Requirement for IV access for any indication other than for treatment of dehydration.
Indwelling IV catheter, except for one intended only for collection of clinical laboratory specimens.
Any condition precluding SC infusion or infusion site evaluation
Any reason (prior to study enrollment) for a hospital admission or an extended stay in the ED for other than dehydration.
Known hypersensitivity to hyaluronidase or hylenex.
Known hyponatremia (< 130 mEg/L) or hypernatremia (> 155 mEq/L).
Known hypokalemia (< 3.0 mEq/L).
Any medical condition likely to interfere with the patient's ability to fully complete all protocol-specified interventions, the ability to undergo all protocol-specified assessments, or likely to prolong the patient's need for medical attention beyond that required for treatment of dehydration.
Participation in an investigational drug or device study within 30 days prior to enrollment in this study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00773175

Locations

United States, Connecticut
Connecticut Children's Medical Center	Recruiting
Hartford, Connecticut, United States, 06106
Contact: Bertha Robbins 860-545-9523 brobbin@ccmckids.org
Principal Investigator: Sharon Smith, MD
United States, Florida
Tampa General Hospital Children's Medical Center	Recruiting
Tampa, Florida, United States, 33606
Contact: Denise Fife, RN 813-844-7829 dafife@tgh.org
Principal Investigator: Neil Reinhardt, MD
United States, Georgia
Children's Healthcare of Atlanta - Scottish Rite	Recruiting
Atlanta, Georgia, United States, 30342
Contact: Phillip Spandorfer, MD 404-256-3178
Principal Investigator: Phillip Spandorfer, MD
North Georgia Clinical Research	Recruiting
Dalton, Georgia, United States, 30721
Contact: Ronald Tull, MD, FAAP 706-876-2159 respy@whitespediatrics.com
Principal Investigator: Ronald Tull, MD, FAAP
United States, Indiana
Memorial Hospital	Recruiting
South Bend, Indiana, United States, 46601
Contact: George Maher, DO 574-647-7883 gmaher@memorialsb.org
Principal Investigator: George Maher, DO
United States, Missouri
The Children's Mercy Hospital & Clinics	Recruiting
Kansas City, Missouri, United States, 64108
Contact: Shirlee S Rusk, RN 816-234-3299 ssrusk@cmh.edu
Principal Investigator: Beth Schissel, MD
United States, New Jersey
St. Joseph's Children's Hospital	Recruiting
Paterson, New Jersey, United States, 07503
Contact: JoAnne Neville 973-754-3072 Nevillej@sjhmc.org
Principal Investigator: Michael Lamacchia, MD
United States, New York
Staten Island University Hospital Emergency Department	Recruiting
Staten Island, New York, United States, 10305
Contact: Barry Hahn, MD 917-363-7573 barry_hahn@yahoo.com
Principal Investigator: Barry Hahn, MD
United States, Ohio
Rainbow Children's and Babies Hospital	Recruiting
Cleveland, Ohio, United States, 44106
Contact: Haitham Haddad, MD 216-844-1332 Eloise.lemon @Uhhospitals.org
Principal Investigator: Haitham Haddad, MD
United States, Texas
Texas Children's Hospital	Not yet recruiting
Houston, Texas, United States, 77030
Contact: Victor Gonzalez, MD 832-824-5977 vmgonza1@texaschildrens.org
Principal Investigator: Coburn H Allen, MD
Children's Medical Center Dallas	Recruiting
Dallas, Texas, United States, 75235
Contact: Pam Okada, MD 214-456-2683
Principal Investigator: Pam Okada, MD

Sponsors and Collaborators

Halozyme Therapeutics

Baxter Healthcare Corporation

Investigators

Principal Investigator:

Coburn H Allen, MD

Texas Children's Hospital

More Information

Responsible Party:	Baxter Healthcare Corporation ( George Harb, Therapeutic Area Lead )
Study ID Numbers:	HZ2-08-03
Study First Received:	October 15, 2008
Last Updated:	December 17, 2008
ClinicalTrials.gov Identifier:	NCT00773175
Health Authority:	United States: Food and Drug Administration

Keywords provided by Halozyme Therapeutics:

pediatric
hylenex
subcutaneous infusion

hyaluronidase
rHuPH20
recombinant human hyaluronidase

Study placed in the following topic categories:

Metabolic Diseases
Water-Electrolyte Imbalance
Metabolic disorder
Dehydration

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 14, 2009