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

This study has been terminated.
(Strategic business decision (not related to safety or efficacy concerns))
Sponsor:
Collaborator:
Halozyme Therapeutics
Information provided by (Responsible Party):
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT01116102
First received: April 30, 2010
Last updated: October 17, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention Phase
Dehydration
Drug: Subcutaneous HYLENEX (recombinant human hyaluronidase) and Lactated Ringer's solution
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Baxter Healthcare Corporation:

Primary Outcome Measures:
  • Maximum Measured In-line Fluid Pressure [ Time Frame: 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 ] [ Designated as safety issue: No ]
    Maximum fluid pressure measured (15 sec period) in delivery line during subcutaneous fluid infusion at specified time point after start of infusion


Secondary Outcome Measures:
  • Number of Attempts Needed for Successful Subcutaneous Catheter/Needle Placement [ Time Frame: end of catheter/needle placement ] [ Designated as safety issue: No ]
  • Cumulative Fluid Volume Delivered [ Time Frame: 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 ] [ Designated as safety issue: No ]
  • Technical Challenges Encountered During Fluid Infusion [ Time Frame: at any occurence of a defined challenge or at end of infusion if no challenges occurred ] [ Designated as safety issue: No ]
    Observed challenges, including catheter kinking, catheter/needle dislodgement/pull-out, infusion pump alarm, other technical problems


Enrollment: 20
Study Start Date: May 2010
Study Completion Date: June 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01116102

Locations
United States, West Virginia
Kendle International, Inc. Drug Study Unit
Morgantown, West Virginia, United States, 26505
Sponsors and Collaborators
Baxter Healthcare Corporation
Halozyme Therapeutics
Investigators
Study Director: George Harb, MD, MPH Baxter Healthcare Corporation
  More Information

No publications provided

Responsible Party: Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT01116102     History of Changes
Other Study ID Numbers: 1838-009
Study First Received: April 30, 2010
Results First Received: September 12, 2011
Last Updated: October 17, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Baxter Healthcare Corporation:
dehydration
fluid therapy
hyaluronoglucosaminidase
hyaluronidase
hypodermoclysis
clysis
subcutaneous hydration
subcutaneous rehydration
hyaluronan
rHuPH20

Additional relevant MeSH terms:
Dehydration
Water-Electrolyte Imbalance
Metabolic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014