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

• Status: Completed
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Baxter Healthcare Corporation
• Collaborators: Halozyme Therapeutics; PPD

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 (Gorelick dehydration classification: presence of 1 to 6 [of possible 10] moderate or severe signs and symptoms) requiring parenteral rehydration

Exclusion Criteria:

• In shock or life-threatening situation (other than dehydration)

• Severe dehydration

• Requires intravenous (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 emergency department 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