drugset / Trial / NCT00477152
Study of Subcutaneous Rehydration With Recombinant Human Hyaluronidase for Infants and Children
Phase 4
Completed
52 enrolled
Baxter Healthcare Corporation
Halozyme Therapeutics · collabPPD Development, LP · collab
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2007-08
- Primary completion
- 2008-06
- Completion
- 2008-06
Publications
- Background Gorelick MH, Shaw KN, Murphy KO. Validity and reliability of clinical signs in the diagnosis of dehydration in children. Pediatrics. 1997 May;99(5):E6. doi: 10.1542/peds.99.5.e6.
- Results Allen CH, Etzwiler LS, Miller MK, Maher G, Mace S, Hostetler MA, Smith SR, Reinhardt N, Hahn B, Harb G; INcreased Flow Utilizing Subcutaneously-Enabled Pediatric Rehydration Study Collaborative Research Group. Recombinant human hyaluronidase-enabled subcutaneous pediatric rehydration. Pediatrics. 2009 Nov;124(5):e858-67. doi: 10.1542/peds.2008-3588. Epub 2009 Oct 5.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | rHuPH20 | Protein / enzyme biologic | 150 iu | Subcutaneous |
Indications
No indication recorded.