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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Metabolic Diseases
Pathologic Processes
Water-Electrolyte Imbalance
Pharmaceutical Solutions
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014