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

NCT ID: NCT01116102

Last Updated: 2011-10-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2010-06-30

Brief Summary

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.

Conditions

Dehydration

Study Design

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

Study Groups

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.

Group Type: EXPERIMENTAL

Subcutaneous HYLENEX (recombinant human hyaluronidase) and Lactated Ringer's solution

Intervention Type: DRUG

Subcutaneous administration of 150 U HYLENEX, followed by 1000 mL Lactated Ringer's solution

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.

Group Type: EXPERIMENTAL

Subcutaneous HYLENEX (recombinant human hyaluronidase) and Lactated Ringer's solution

Intervention Type: DRUG

Subcutaneous administration of 150 U HYLENEX, followed by 1000 mL Lactated Ringer's solution

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.

Group Type: EXPERIMENTAL

Subcutaneous HYLENEX (recombinant human hyaluronidase) and Lactated Ringer's solution

Intervention Type: DRUG

Subcutaneous administration of 150 U HYLENEX, followed by 1000 mL Lactated Ringer's solution

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.

Group Type: EXPERIMENTAL

Subcutaneous HYLENEX (recombinant human hyaluronidase) and Lactated Ringer's solution

Intervention Type: DRUG

Subcutaneous administration of 150 U HYLENEX, followed by 1000 mL Lactated Ringer's solution

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.

Group Type: EXPERIMENTAL

Subcutaneous HYLENEX (recombinant human hyaluronidase) and Lactated Ringer's solution

Intervention Type: DRUG

Subcutaneous administration of 150 U HYLENEX, followed by 1000 mL Lactated Ringer's solution

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.

Group Type: EXPERIMENTAL

Subcutaneous HYLENEX (recombinant human hyaluronidase) and Lactated Ringer's solution

Intervention Type: DRUG

Subcutaneous administration of 150 U HYLENEX, followed by 1000 mL Lactated Ringer's solution

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.

Group Type: EXPERIMENTAL

Subcutaneous HYLENEX (recombinant human hyaluronidase) and Lactated Ringer's solution

Intervention Type: DRUG

Subcutaneous administration of 150 U HYLENEX, followed by 1000 mL Lactated Ringer's solution

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.

Group Type: EXPERIMENTAL

Subcutaneous HYLENEX (recombinant human hyaluronidase) and Lactated Ringer's solution

Intervention Type: DRUG

Subcutaneous administration of 150 U HYLENEX, followed by 1000 mL Lactated Ringer's solution

Interventions

Subcutaneous HYLENEX (recombinant human hyaluronidase) and Lactated Ringer's solution

Subcutaneous administration of 150 U HYLENEX, followed by 1000 mL Lactated Ringer's solution

Intervention Type: DRUG

Other Intervention Names

rHuPH20; LR solution

Eligibility 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.

• 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

Kendle International, Inc. Drug Study Unit

Morgantown, West Virginia, United States

Countries

United States

Other Identifiers

1838-009

Identifier Type: -

Identifier Source: org_study_id