At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 52 enrolled
Drug / intervention
hyaluronidase (human recombinant)/rehydration fluiddrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 4 clinical trial evaluating hyaluronidase (human recombinant)/rehydration fluid for Dehydration. Completed, enrolled 52 participants.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDehydration
Countries--
CollaboratorsHalozyme Therapeutics, PPD Development, LP
Timeline
Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 2007
Enrollment StartAug 2007
Primary CompletionJun 2008
TodayJul 2026
First PostedMay 22, 2007
Enrollment StartAug 1, 2007
Primary CompletionJun 1, 2008
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 19.1 years ago
Interventions
hyaluronidase (human recombinant)/rehydration fluiddrug
Single 150 U subcutaneous (SC) HYLENEX dose administered immediately prior to start of SC infusion of rehydration fluid. Additional 150 U HYLENEX dose to be administered prior to any additional fluid infusion beyond 24 hours.