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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01116102
• Date of registration: 30/04/2010
• Primary sponsor: Baxter Healthcare Corporation
• Public title: Study of In-line Pressure Using Various Techniques of Subcutaneous Administration of Fluids Enabled by Human Recombinant Hyaluronidase (INFUSE-AT1A) INFUSE-AT1A
• Scientific 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
• Date of first enrolment: May 2010
• Target sample size: 20
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT01116102
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: George Harb, MD, MPH
• Affiliation: Baxter Healthcare Corporation

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 60 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Dehydration

Intervention(s)

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

Primary Outcome(s)

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]

Secondary Outcome(s)

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]

Number of Attempts Needed for Successful Subcutaneous Catheter/Needle Placement [Time Frame: end of catheter/needle placement]

Technical Challenges Encountered During Fluid Infusion [Time Frame: at any occurence of a defined challenge or at end of infusion if no challenges occurred]

Secondary ID(s)

1838-009

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Halozyme Therapeutics