Study of Techniques of Subcutaneous Administration of Fluids Enabled by Human Recombinant Hyaluronidase
Information source: Baxter Healthcare Corporation
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Dehydration
Intervention: Lactated Ringer's solution and recombinant human hyaluronidase (Drug); Lactated Ringer's solution and recombinant human hyaluronidase (Drug); Lactated Ringer's solution and recombinant human hyaluronidase (Drug); Lactated Ringer's solution and recombinant human hyaluronidase (Drug); Lactated Ringer's solution and recombinant human hyaluronidase (Drug); Lactated Ringer's solution and recombinant human hyaluronidase (Drug); Lactated Ringer's solution and recombinant human hyaluronidase (Drug); Lactated Ringer's solution and recombinant human hyaluronidase (Drug); Lactated Ringer's solution and recombinant human hyaluronidase (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Baxter Healthcare Corporation Official(s) and/or principal investigator(s):
George Harb, MD, MPH, Study Director, Affiliation: Baxter Healthcare Corporation
Summary
The purpose is to evaluate the ease of use and technical challenges encountered during
subcutaneous infusion of Lactated Ringer's solution, preceded by recombinant human
hyaluronidase (hylenex), utilizing commonly used angiocatheter gauges and button delivery
systems. The safety and tolerability of hylenex-augmented SC infusion of LR through these
delivery systems is also being evaluated.
Clinical Details
Official title: INcreased Flow Utilizing Subcutaneously-Enabled Fluids Administration Technique Study (INFUSE-AT): A Randomized, Open-Label, Parallel Group, Phase IV, Study Evaluating the Techniques of Administration of Subcutaneous Fluids Enabled by Human Recombinant Hyaluronidase (Hylenex) in Healthy Adult Volunteers
Study design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Technical challenges (tube kinks, catheter dislodgement, catheter pull-out, infusion pump beeping, other pump failure, intervention to maintain infusion, other technical challenges) during infusion
Secondary outcome: Multiple ease-of-use measuresSafety and tolerability (catheter placement-associated pain, infusion site reactions, other adverse events)
Eligibility
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- male or female, aged 18 to 60 years
- intact normal skin without potentially obscuring features on both anterior thighs in
the area intended for infusion
- agreeing to no fluid intake for 12 hours prior to start of study infusion
- vital signs within normal range or, if outside normal range, deemed not clinically
significant
- metabolic panel, hematology, virology and standard 10-test urine dipstick tests within
normal range, or if outside normal range, deemed not clinically significant
- if female of child-bearing potential,negative serum pregnancy tests
- negative urine drug screens
- written informed consent for participation
Exclusion Criteria:
- lower extremity edema
- lower extremity pathology that could interfere with study outcome
- history of cardiovascular disease
- rales on lung auscultation
- known allergy to hyaluronidase or other ingredient in the formulation of hylenex
- pregnancy or breast-feeding a child
- exposure to any experimental drug within 30 days prior to study participation
- previous participation in this study
Locations and Contacts
MDS Pharma Services, Lincoln, Nebraska 68502, United States; Recruiting
Angie Badgett, Phone: 402-437-6351, Email: angie.badgett@mdsinc.com
MDS Pharma Services, Neptune, New Jersey 07753, United States; Recruiting
Brandi Carmona, Phone: 732-502-8900, Ext: 6990, Email: brandi.carmona@mdsinc.com
Additional Information
MDS Pharma Services Study Participation Web Page
Starting date: December 2008
Ending date: January 2009
Last updated: December 11, 2008
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