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

NCT01116102 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2011-10-24

Study results available
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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

Interventions

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

Sponsors & Collaborators

  • Halozyme Therapeutics

    collaborator INDUSTRY

  • Baxter Healthcare Corporation

    lead INDUSTRY

Principal Investigators

  • George Harb, MD, MPH · Baxter Healthcare Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2010-05-31
Completion
2010-06-30

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01116102 on ClinicalTrials.gov