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

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.

Study Overview

• Status: Terminated
• Conditions: Dehydration
• Intervention / Treatment: Drug: Subcutaneous HYLENEX (recombinant human hyaluronidase) and Lactated Ringer's solution

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • West Virginia
    • Morgantown, West Virginia, United States, 26505
      • Kendle International, Inc. Drug Study Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female, aged 18 to 60 years, inclusive.
• Body mass index 19.0 to 35.0 kg/m2
• Intact normal skin without potentially obscuring tattoos, pigmentation, or lesions on the upper back in the area intended for infusion
• Free from any clinically significant abnormality on the basis of medical/medication history or physical examination
• Vital signs and clinical laboratory parameters within normal range or, if outside normal range, deemed not clinically significant
• Negative urine drug and alcohol screens.

Exclusion Criteria:

• Upper back pathology that could interfere with study outcome.
• History of congestive heart failure, known coronary heart disease, active or recent pulmonary disease, or renal insufficiency.
• Rales on lung auscultation.
• Known allergy to hyaluronidase or any other ingredient in the formulation of hylenex recombinant
• Treatment with furosemide, benzodiazepines, or phenytoin.
• Pregnancy or breastfeeding.
• Exposure to any experimental drug within 30 days prior to study admission, or previous participation in this study.
• Any other reason which, in the investigator's opinion, would prevent the safe participation in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 24 ga catheter, dose flush, single-step rate scheme; Single 150 U subcutaneous (SC) dose of HYLENEX and 3 mL Lactated Ringer's solution flush administered through 24 gauge plastic catheter; followed by SC infusion of 1000 mL Lactated Ringer's solution via large-volume infusion pump at 250 mL/h for the first hour and 200 mL/hr for the remainder of the infusion.	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; Other Names: rHuPH20; LR solution
Experimental: 24 ga catheter, no dose flush, single-step rate scheme; Single 150 U subcutaneous (SC) dose of HYLENEX (without a Lactated Ringer's solution flush) administered through 24 gauge plastic catheter; followed by SC infusion of 1000 mL Lactated Ringer's solution via large-volume infusion pump at 250 mL/h for the first hour and 200 mL/hr for the remainder of the infusion.	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; Other Names: rHuPH20; LR solution
Experimental: 24 ga catheter, dose flush, up-titrated rate scheme; Single 150 U subcutaneous (SC) dose of HYLENEX and 3 mL Lactated Ringer's solution flush administered through 24 gauge plastic catheter; followed by SC infusion of 1000 mL Lactated Ringer's solution via large-volume infusion pump at 50 mL/h for the first 5 min, 100 mL/h for the next 5 min, 285 mL/h for the next 50 min and 200 mL/h for the remainder of the infusion.	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; Other Names: rHuPH20; LR solution
Experimental: 24 ga catheter, no dose flush, up-titrated rate scheme; Single 150 U subcutaneous (SC) dose of HYLENEX (without a Lactated Ringer's solution flush) administered through 24 gauge plastic catheter; followed by SC infusion of 1000 mL Lactated Ringer's solution via large-volume infusion pump at 50 mL/h for the first 5 min, 100 mL/h for the next 5 min, 285 mL/h for the next 50 min and 200 mL/h for the remainder of the infusion.	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; Other Names: rHuPH20; LR solution
Experimental: 25 ga needle, dose flush, single-step rate scheme; Single 150 U subcutaneous (SC) dose of HYLENEX and 3 mL Lactated Ringer's solution flush administered through 25 gauge metal butterfly needle; followed by SC infusion of 1000 mL Lactated Ringer's solution via large-volume infusion pump at 250 mL/h for the first hour and 200 mL/hr for the remainder of the infusion.	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; Other Names: rHuPH20; LR solution
Experimental: 25 ga needle, no dose flush, single-step rate scheme; Single 150 U subcutaneous (SC) dose of HYLENEX (without a Lactated Ringer's solution flush) administered through 25 gauge metal butterfly needle; followed by SC infusion of 1000 mL Lactated Ringer's solution via large-volume infusion pump at 250 mL/h for the first hour and 200 mL/hr for the remainder of the infusion.	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; Other Names: rHuPH20; LR solution
Experimental: 25 ga needle, dose flush, up-titrated rate scheme; Single 150 U subcutaneous (SC) dose of HYLENEX and 3 mL Lactated Ringer's solution flush administered through 25 gauge metal butterfly needle; followed by SC infusion of 1000 mL Lactated Ringer's solution via large-volume infusion pump at 50 mL/h for the first 5 min, 100 mL/h for the next 5 min, 285 mL/h for the next 50 min and 200 mL/h for the remainder of the infusion.	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; Other Names: rHuPH20; LR solution
Experimental: 25 ga needle, no dose flush, up-titrated rate scheme; Single 150 U subcutaneous (SC) dose of HYLENEX (without a Lactated Ringer's solution flush) administered through 25 gauge metal butterfly needle; followed by SC infusion of 1000 mL Lactated Ringer's solution via large-volume infusion pump at 50 mL/h for the first 5 min, 100 mL/h for the next 5 min, 285 mL/h for the next 50 min and 200 mL/h for the remainder of the infusion.	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; Other Names: rHuPH20; LR solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Measured In-line Fluid Pressure	Maximum fluid pressure measured (15 sec period) in delivery line during subcutaneous fluid infusion at specified time point after start of infusion	each minute for the first 15 minutes of fluid infusion, every 5 minutes for the next 45 minutes of infusion, and every 15 minutes thereafter until the end of infusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Attempts Needed for Successful Subcutaneous Catheter/Needle Placement		end of catheter/needle placement
Cumulative Fluid Volume Delivered		each minute for the first 15 minutes of fluid infusion, every 5 minutes for the next 45 minutes of infusion, and every 15 minutes thereafter until the end of infusion
Technical Challenges Encountered During Fluid Infusion	Observed challenges, including catheter kinking, catheter/needle dislodgement/pull-out, infusion pump alarm, other technical problems	at any occurence of a defined challenge or at end of infusion if no challenges occurred

Collaborators and Investigators

• Sponsor: Baxter Healthcare Corporation
• Collaborators: Halozyme Therapeutics

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): May 1, 2010
• Study Completion (Actual): June 1, 2010

Study Registration Dates

• First Submitted: April 30, 2010
• First Submitted That Met QC Criteria: May 3, 2010
• First Posted (Estimate): May 4, 2010

Study Record Updates

• Last Update Posted (Estimate): October 24, 2011
• Last Update Submitted That Met QC Criteria: October 17, 2011
• Last Verified: October 1, 2011

More Information

Terms related to this study

• Keywords: dehydration; hyaluronan; hyaluronidase; fluid therapy; hyaluronoglucosaminidase; hypodermoclysis; clysis; subcutaneous hydration; subcutaneous rehydration; rHuPH20
• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Water-Electrolyte Imbalance; Dehydration; Pharmaceutical Solutions
• Other Study ID Numbers: 1838-009