NCT01116102

Study of In-line Pressure Using Various Techniques of Subcutaneous Administration of Fluids Enabled by Human Recombinant Hyaluronidase (INFUSE-AT1A)

The INcreased Flow Utilizing Subcutaneously-Enabled Fluids Administration Technique 1A Study (INFUSE-AT 1A): A Randomized, Parallel Group Study to Evaluate the In-line Pressure, Flow Rate, Safety and Tolerability of Hylenex-facilitated Subcutaneous Fluid Administration In Healthy Volunteers Using Various Subcutaneous Infusion Techniques

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Baxter Healthcare Corporation · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The purpose is to characterize the in-line pressure profiles associated with several infusion technique factors during subcutaneous (SC) infusion of Lactated Ringer's solution, preceded by recombinant human hyaluronidase (hylenex). The safety and tolerability of hylenex-augmented SC infusion of Lactated Ringer's solution fluid is also being evaluated.

Conditions

• Dehydration

Interventions

Type	Name	Description
DRUG	Subcutaneous HYLENEX (recombinant human hyaluronidase) and Lactated Ringer's solution	Subcutaneous administration of 150 U HYLENEX, followed by 1000 mL Lactated Ringer's solution

Timeline

• Start date: 2010-05-01
• Primary completion: 2010-05-01
• Completion: 2010-06-01
• First posted: 2010-05-04
• Last updated: 2011-10-24
• Results posted: 2011-10-18

Locations

1 site across 1 country: United States