Study of Techniques of Subcutaneous Administration of Fluids Enabled by Human Recombinant Hyaluronidase

NCT ID: NCT00807885

Last Updated: 2011-10-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2009-01-31

Brief Summary

The purpose is to evaluate the ease of use and technical challenges encountered during subcutaneous infusion of Lactated Ringer's (LR) 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.

Conditions

Dehydration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tegaderm-secured 24 ga Teflon catheter

subcutaneous administration of a single 150 U dose of hylenex, followed by subcutaneous infusion (delivered by large volume infusion pump) of 1000 mL Lactated Ringer's solution, both delivered through a 24-gauge, 0.75 inch long, Teflon angiocatheter secured with Tegaderm

Group Type: EXPERIMENTAL

hylenex-facilitated subcutaneous Lactated Ringer's infusion

Intervention Type: DRUG

single subcutaneous 150 U dose of hylenex, followed by subcutaneous infusion of 1000 mL Lactated Ringer's solution

Tape-secured 24 ga Teflon catheter

subcutaneous administration of a single 150 U dose of hylenex, followed by subcutaneous infusion (delivered by large volume infusion pump) of 1000 mL Lactated Ringer's solution, both delivered through a 24-gauge, 0.75 inch long, Teflon angiocatheter secured with a tape double chevron

Group Type: EXPERIMENTAL

hylenex-facilitated subcutaneous Lactated Ringer's infusion

Intervention Type: DRUG

single subcutaneous 150 U dose of hylenex, followed by subcutaneous infusion of 1000 mL Lactated Ringer's solution

Tegaderm-secured 24 ga polyurethane catheter

subcutaneous administration of a single 150 U dose of hylenex, followed by subcutaneous infusion (delivered by large volume infusion pump) of 1000 mL Lactated Ringer's solution, both delivered through a 24-gauge, 0.75 inch long, polyurethane angiocatheter secured with Tegaderm

Group Type: EXPERIMENTAL

hylenex-facilitated subcutaneous Lactated Ringer's infusion

Intervention Type: DRUG

single subcutaneous 150 U dose of hylenex, followed by subcutaneous infusion of 1000 mL Lactated Ringer's solution

Tape-secured 24 ga polyurethane catheter

subcutaneous administration of a single 150 U dose of hylenex, followed by subcutaneous infusion (delivered by large volume infusion pump) of 1000 mL Lactated Ringer's solution, both delivered through a 24-gauge, 0.75 inch long, polyurethane angiocatheter secured with a tape double chevron

Group Type: EXPERIMENTAL

hylenex-facilitated subcutaneous Lactated Ringer's infusion

Intervention Type: DRUG

single subcutaneous 150 U dose of hylenex, followed by subcutaneous infusion of 1000 mL Lactated Ringer's solution

Tegaderm-secured 20 ga Teflon catheter

subcutaneous administration of a single 150 U dose of hylenex, followed by subcutaneous infusion (delivered by large volume infusion pump) of 1000 mL Lactated Ringer's solution, both delivered through a 20-gauge, 1.0 inch long, Teflon angiocatheter secured with Tegaderm

Group Type: EXPERIMENTAL

hylenex-facilitated subcutaneous Lactated Ringer's infusion

Intervention Type: DRUG

single subcutaneous 150 U dose of hylenex, followed by subcutaneous infusion of 1000 mL Lactated Ringer's solution

Tape-secured 20 ga Teflon catheter

subcutaneous administration of a single 150 U dose of hylenex, followed by subcutaneous infusion (delivered by large volume infusion pump) of 1000 mL Lactated Ringer's solution, both delivered through a 20-gauge, 1.0 inch long, Teflon angiocatheter secured with a tape double chevron

Group Type: EXPERIMENTAL

hylenex-facilitated subcutaneous Lactated Ringer's infusion

Intervention Type: DRUG

single subcutaneous 150 U dose of hylenex, followed by subcutaneous infusion of 1000 mL Lactated Ringer's solution

Tegaderm-secured 20 ga polyurethane catheter

subcutaneous administration of a single 150 U dose of hylenex, followed by subcutaneous infusion (delivered by large volume infusion pump) of 1000 mL Lactated Ringer's solution, both delivered through a 20-gauge, 1.0 inch long, polyurethane angiocatheter secured with Tegaderm

Group Type: EXPERIMENTAL

hylenex-facilitated subcutaneous Lactated Ringer's infusion

Intervention Type: DRUG

single subcutaneous 150 U dose of hylenex, followed by subcutaneous infusion of 1000 mL Lactated Ringer's solution

Tape-secured 20 ga polyurethane catheter

subcutaneous administration of a single 150 U dose of hylenex, followed by subcutaneous infusion (delivered by large volume infusion pump) of 1000 mL Lactated Ringer's solution, both delivered through a 20-gauge, 1.0 inch long, polyurethane angiocatheter secured with a tape double chevron

Group Type: EXPERIMENTAL

hylenex-facilitated subcutaneous Lactated Ringer's infusion

Intervention Type: DRUG

single subcutaneous 150 U dose of hylenex, followed by subcutaneous infusion of 1000 mL Lactated Ringer's solution

SC button with 27 ga X 9 mm needle

subcutaneous administration of a single 150 U dose of hylenex, followed by subcutaneous infusion (delivered by large volume infusion pump) of 1000 mL Lactated Ringer's solution, both delivered through a button-type subcutaneous delivery system (with a 27-gauge, 9 mm long metal needle)

Group Type: EXPERIMENTAL

hylenex-facilitated subcutaneous Lactated Ringer's infusion

Intervention Type: DRUG

single subcutaneous 150 U dose of hylenex, followed by subcutaneous infusion of 1000 mL Lactated Ringer's solution

Interventions

hylenex-facilitated subcutaneous Lactated Ringer's infusion

single subcutaneous 150 U dose of hylenex, followed by subcutaneous infusion of 1000 mL Lactated Ringer's solution

Intervention Type: DRUG

Other Intervention Names

hylenex; rHuPH20; LR; LR solution

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Halozyme Therapeutics

INDUSTRY

Sponsor Role: collaborator

Baxter Healthcare Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

George Harb, MD, MPH

Role: STUDY_DIRECTOR

Baxter Healthcare Corporation

Locations

MDS Pharma Services

Lincoln, Nebraska, United States

MDS Pharma Services

Neptune City, New Jersey, United States

Countries

United States

Other Identifiers

1838-007

Identifier Type: -

Identifier Source: org_study_id