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Sponsors and Collaborators: |
Halozyme Therapeutics Baxter Healthcare Corporation |
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Information provided by: | Halozyme Therapeutics |
ClinicalTrials.gov Identifier: | NCT00773175 |
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 |
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 |
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)
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Drug: recombinant human hyaluronidase
150 Units in 1 mL
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Intravenous: Active Comparator
Isotonic fluid rehydration by IV
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Drug: recombinant human hyaluronidase
150 Units in 1 mL
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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.
Ages Eligible for Study: | up to 3 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Principal Investigator: | Coburn H Allen, MD | Texas Children's Hospital |
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 |
pediatric hylenex subcutaneous infusion |
hyaluronidase rHuPH20 recombinant human hyaluronidase |
Metabolic Diseases Water-Electrolyte Imbalance Metabolic disorder Dehydration |
Pathologic Processes |