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

Baxter

Status and phase: Terminated; Phase 4

Conditions: Dehydration

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01116102

1838-009

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 8 patient groups

24 ga catheter, dose flush, single-step rate scheme

Experimental group

Description:

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.

Treatment:

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

24 ga catheter, no dose flush, single-step rate scheme

Experimental group

Description:

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.

Treatment:

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

24 ga catheter, dose flush, up-titrated rate scheme

Experimental group

Description:

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.

Treatment:

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

24 ga catheter, no dose flush, up-titrated rate scheme

Experimental group

Description:

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.

Treatment:

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

25 ga needle, dose flush, single-step rate scheme

Experimental group

Description:

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.

Treatment:

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

25 ga needle, no dose flush, single-step rate scheme

Experimental group

Description:

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.

Treatment:

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

25 ga needle, dose flush, up-titrated rate scheme

Experimental group

Description:

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.

Treatment:

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

25 ga needle, no dose flush, up-titrated rate scheme

Experimental group

Description:

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.

Treatment:

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