Study of Techniques of Subcutaneous Administration of Fluids Enabled by Human Recombinant Hyaluronidase
Official Title
INcreased Flow Utilizing Subcutaneously-Enabled Fluids Administration Technique Study (INFUSE-AT): A Randomized, Open-Label, Parallel Group, Phase IV, Study Evaluating the Techniques of Administration of Subcutaneous Fluids Enabled by Human Recombinant Hyaluronidase (Hylenex) in Healthy Adult Volunteers
Acronym
INFUSE-AT
Organization
Baxter Healthcare CorporationINDUSTRY
Status Module
Record Verification Date
Oct 2011
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Dec 2008
Primary Completion Date
Jan 2009Actual
Completion Date
Jan 2009Actual
First Submitted Date
Dec 10, 2008
First Submission Date that Met QC Criteria
Dec 11, 2008
First Posted Date
Dec 12, 2008Estimated
Results Waived
Not provided
Results First Submitted Date
Sep 12, 2011
Results First Submitted that Met QC Criteria
Sep 12, 2011
Results First Posted Date
Oct 18, 2011Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Oct 21, 2011
Last Update Posted Date
Oct 26, 2011Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Baxter Healthcare CorporationINDUSTRY
Collaborators
Name
Class
Halozyme Therapeutics
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose is to evaluate the ease of use and technical challenges encountered during subcutaneous infusion of Lactated Ringer's (LR) solution, preceded by recombinant human hyaluronidase (hylenex), utilizing commonly used angiocatheter gauges and button delivery systems. The safety and tolerability of hylenex-augmented SC infusion of LR through these delivery systems is also being evaluated.
Detailed Description
Not provided
Conditions Module
Conditions
Dehydration
Keywords
dehydration
fluid therapy
hyaluronoglucosaminidase
hyaluronidase
hypodermoclysis
clysis
subcutaneous hydration
subcutaneous rehydration
hyaluronan
rHuPH20
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 4
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
100Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Tegaderm-secured 24 ga Teflon catheter
Experimental
subcutaneous administration of a single 150 U dose of hylenex, followed by subcutaneous infusion (delivered by large volume infusion pump) of 1000 mL Lactated Ringer's solution, both delivered through a 24-gauge, 0.75 inch long, Teflon angiocatheter secured with Tegaderm
subcutaneous administration of a single 150 U dose of hylenex, followed by subcutaneous infusion (delivered by large volume infusion pump) of 1000 mL Lactated Ringer's solution, both delivered through a 24-gauge, 0.75 inch long, Teflon angiocatheter secured with a tape double chevron
subcutaneous administration of a single 150 U dose of hylenex, followed by subcutaneous infusion (delivered by large volume infusion pump) of 1000 mL Lactated Ringer's solution, both delivered through a 24-gauge, 0.75 inch long, polyurethane angiocatheter secured with Tegaderm
subcutaneous administration of a single 150 U dose of hylenex, followed by subcutaneous infusion (delivered by large volume infusion pump) of 1000 mL Lactated Ringer's solution, both delivered through a 24-gauge, 0.75 inch long, polyurethane angiocatheter secured with a tape double chevron
single subcutaneous 150 U dose of hylenex, followed by subcutaneous infusion of 1000 mL Lactated Ringer's solution
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Technical Challenges
Protocol-specified challenges encountered during subcutaneous (SC) hylenex administration and/or SC infusion of Lactated Ringer's solution, including SC catheter kinking, catheter/button dislodgement, catheter/button pull-out, infusion pump alarm, other pump failure, healthcare provider intervention to secure/maintain SC infusion eg, re-taping, catheter/button manipulation, etc, and any other type of technical challenge encountered
throughout subcutaneous hylenex and fluid administration period (continuous)
Secondary Outcomes
Measure
Description
Time Frame
Attempts Needed to Successfully Place Subcutaneous Catheter/Button
from start of first attempt until completion of catheter/button placement
Time Needed to Successfully Place Subcutaneous Catheter/Button
from start of first attempt until completion of catheter/button placement
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
male or female, aged 18 to 60 years
intact normal skin without potentially obscuring features on both anterior thighs in the area intended for infusion
agreeing to no fluid intake for 12 hours prior to start of study infusion
vital signs within normal range or, if outside normal range, deemed not clinically significant
metabolic panel, hematology, virology and standard 10-test urine dipstick tests within normal range, or if outside normal range, deemed not clinically significant
if female of child-bearing potential,negative serum pregnancy tests
negative urine drug screens
written informed consent for participation
Exclusion Criteria:
lower extremity edema
lower extremity pathology that could interfere with study outcome
history of cardiovascular disease
rales on lung auscultation
known allergy to hyaluronidase or other ingredient in the formulation of hylenex
pregnancy or breast-feeding a child
exposure to any experimental drug within 30 days prior to study participation
previous participation in this study
Accepts Healthy Volunteers
Yes
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
60 Years
Standard Ages
Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
George Harb, MD, MPH
Baxter Healthcare Corporation
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
MDS Pharma Services
Lincoln
Nebraska
68502
United States
MDS Pharma Services
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Not provided
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Tegaderm-secured 24 ga Teflon Catheter
FG001
Tape-secured 24 ga Teflon Catheter
FG002
Tegaderm-secured 24 ga Polyurethane Catheter
FG003
Tape-secured 24 ga Polyurethane Catheter
FG004
Tegaderm-secured 20 ga Teflon Catheter
FG005
Tape-secured 20 ga Teflon Catheter
FG006
Tegaderm-secured 20 ga Polyurethane Catheter
FG007
Tape-secured 20 ga Polyurethane Catheter
FG008
SC Button With 27 ga X 9 mm Needle
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
FG00010 subjects
FG00111 subjects
FG00211 subjects
FG00310 subjects
FG00412 subjects
FG00512 subjects
FG00612 subjects
FG00711 subjects
FG00811 subjects
COMPLETED
FG00010 subjects
FG00111 subjects
FG00211 subjects
FG00310 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Tegaderm-secured 24 ga Teflon Catheter
BG001
Tape-secured 24 ga Teflon Catheter
BG002
Tegaderm-secured 24 ga Polyurethane Catheter
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Outcome Measures Module
Outcome Measures
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Technical Challenges
Protocol-specified challenges encountered during subcutaneous (SC) hylenex administration and/or SC infusion of Lactated Ringer's solution, including SC catheter kinking, catheter/button dislodgement, catheter/button pull-out, infusion pump alarm, other pump failure, healthcare provider intervention to secure/maintain SC infusion eg, re-taping, catheter/button manipulation, etc, and any other type of technical challenge encountered
ITT (all treated subjects)
Posted
Number
participants
throughout subcutaneous hylenex and fluid administration period (continuous)
subcutaneous administration of a single 150 U dose of hylenex, followed by subcutaneous infusion (delivered by large volume infusion pump) of 1000 mL Lactated Ringer's solution, both delivered through a 20-gauge, 1.0 inch long, Teflon angiocatheter secured with Tegaderm
subcutaneous administration of a single 150 U dose of hylenex, followed by subcutaneous infusion (delivered by large volume infusion pump) of 1000 mL Lactated Ringer's solution, both delivered through a 20-gauge, 1.0 inch long, Teflon angiocatheter secured with a tape double chevron
subcutaneous administration of a single 150 U dose of hylenex, followed by subcutaneous infusion (delivered by large volume infusion pump) of 1000 mL Lactated Ringer's solution, both delivered through a 20-gauge, 1.0 inch long, polyurethane angiocatheter secured with Tegaderm
subcutaneous administration of a single 150 U dose of hylenex, followed by subcutaneous infusion (delivered by large volume infusion pump) of 1000 mL Lactated Ringer's solution, both delivered through a 20-gauge, 1.0 inch long, polyurethane angiocatheter secured with a tape double chevron
subcutaneous administration of a single 150 U dose of hylenex, followed by subcutaneous infusion (delivered by large volume infusion pump) of 1000 mL Lactated Ringer's solution, both delivered through a button-type subcutaneous delivery system (with a 27-gauge, 9 mm long metal needle)
from start of Lactated Ringer's (LR) infusion until 1000 mL LR infused
Neptune City
New Jersey
07753
United States
12 subjects
FG00511 subjectsSubject completed treatment, but lost to follow-up
FG00612 subjects
FG00711 subjects
FG00811 subjects
0 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
0 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
BG003
Tape-secured 24 ga Polyurethane Catheter
BG004
Tegaderm-secured 20 ga Teflon Catheter
BG005
Tape-secured 20 ga Teflon Catheter
BG006
Tegaderm-secured 20 ga Polyurethane Catheter
BG007
Tape-secured 20 ga Polyurethane Catheter
BG008
SC Button With 27 ga X 9 mm Needle
BG009
Total
Total of all reporting groups
10
BG00111
BG00211
BG00310
BG00412
BG00512
BG00612
BG00711
BG00811
BG009100
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
Between 18 and 65 years
BG00010
BG00111
BG00211
BG00310
BG004
>=65 years
BG0000
BG0010
BG0020
BG0030
BG004
Age Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00034.6± 9.39
BG00136.0± 10.6
BG00233.8± 10.4
BG00335.3± 10.9
BG00434.0± 12.5
BG00534.3± 10.3
BG00633.6± 10.7
BG00732.4± 12.7
BG00836.6± 12.3
BG00934.5± 10.8
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0003
BG0011
BG0028
BG0033
BG0043
BG0056
BG0065
BG0074
BG0085
BG00938
Male
BG0007
BG00110
BG0023
BG0037
BG004
Region of Enrollment
Number
participants
Title
Denominators
Categories
United States
Title
Measurements
BG00010
BG00111
BG00211
BG00310
BG00412
BG00512
BG00612
BG00711
BG00811
BG009100
OG002
Tegaderm-secured 24 ga Polyurethane Catheter
OG003
Tape-secured 24 ga Polyurethane Catheter
OG004
Tegaderm-secured 20 ga Teflon Catheter
OG005
Tape-secured 20 ga Teflon Catheter
OG006
Tegaderm-secured 20 ga Polyurethane Catheter
OG007
Tape-secured 20 ga Polyurethane Catheter
OG008
SC Button With 27 ga X 9 mm Needle
Units
Counts
Participants
OG00010
OG00111
OG00211
OG00310
OG00412
OG00512
OG00612
OG00711
OG00811
Title
Denominators
Categories
Subjects with at Least One Technical Challenge
Title
Measurements
OG0002
OG0013
OG0022
OG0032
OG0042
OG0052
OG0063
OG0072
OG0083
Subjects with No Technical Challenges
Title
Measurements
OG0008
OG0018
OG0029
OG003
Subjects with 1 TEchnical Challenge
Title
Measurements
OG0002
OG0013
OG0022
OG003
Subjects with 2 Technical Challenges
Title
Measurements
OG0000
OG0010
OG0020
OG003
Subjects with 3 Technical Challenges
Title
Measurements
OG0000
OG0010
OG0020
OG003
Subjects with Catheter Kinking
Title
Measurements
OG0000
OG0011
OG0020
OG003
Subjects with Catheter Dislodgement
Title
Measurements
OG0000
OG0010
OG0020
OG003
Subjects with Catheter Pulled Out
Title
Measurements
OG0000
OG0010
OG0020
OG003
Subjects with Infusion Pump Alarm
Title
Measurements
OG0002
OG0012
OG0022
OG003
Subjects with Infusion Pump Failure
Title
Measurements
OG0000
OG0010
OG0020
OG003
Secondary
Attempts Needed to Successfully Place Subcutaneous Catheter/Button
ITT (all treated subjects)
Posted
Number
participants
from start of first attempt until completion of catheter/button placement
ID
Title
Description
OG000
Tegaderm-secured 24 ga Teflon Catheter
OG001
Tape-secured 24 ga Teflon Catheter
OG002
Tegaderm-secured 24 ga Polyurethane Catheter
OG003
Tape-secured 24 ga Polyurethane Catheter
OG004
Tegaderm-secured 20 ga Teflon Catheter
OG005
Tape-secured 20 ga Teflon Catheter
OG006
Tegaderm-secured 20 ga Polyurethane Catheter
OG007
Tape-secured 20 ga Polyurethane Catheter
OG008
SC Button With 27 ga X 9 mm Needle
Units
Counts
Participants
OG00010
OG00111
OG00211
OG003
Title
Denominators
Categories
1 Attempt
Title
Measurements
OG00010
OG00111
OG00210
OG003
Secondary
Time Needed to Successfully Place Subcutaneous Catheter/Button
ITT (all treated subjects)
Posted
Median
Full Range
seconds
from start of first attempt until completion of catheter/button placement
ID
Title
Description
OG000
Tegaderm-secured 24 ga Teflon Catheter
OG001
Tape-secured 24 ga Teflon Catheter
OG002
Tegaderm-secured 24 ga Polyurethane Catheter
OG003
Tape-secured 24 ga Polyurethane Catheter
OG004
Tegaderm-secured 20 ga Teflon Catheter
OG005
Tape-secured 20 ga Teflon Catheter
OG006
Tegaderm-secured 20 ga Polyurethane Catheter
OG007
Tape-secured 20 ga Polyurethane Catheter
OG008
SC Button With 27 ga X 9 mm Needle
Units
Counts
Participants
OG00010
OG00111
OG00211
OG003
Title
Denominators
Categories
Title
Measurements
OG00023(1 to 39)
OG00143(2 to 84)
OG00230(2 to 63)
OG003
Secondary
Time Required to Infuse 1000 mL Fluid
ITT (all treated subjects)
Posted
Mean
Standard Deviation
hours
from start of Lactated Ringer's (LR) infusion until 1000 mL LR infused
ID
Title
Description
OG000
Tegaderm-secured 24 ga Teflon Catheter
OG001
Tape-secured 24 ga Teflon Catheter
OG002
Tegaderm-secured 24 ga Polyurethane Catheter
OG003
Tape-secured 24 ga Polyurethane Catheter
OG004
Tegaderm-secured 20 ga Teflon Catheter
OG005
Tape-secured 20 ga Teflon Catheter
OG006
Tegaderm-secured 20 ga Polyurethane Catheter
OG007
Tape-secured 20 ga Polyurethane Catheter
OG008
SC Button With 27 ga X 9 mm Needle
Units
Counts
Participants
OG00010
OG00111
OG00211
OG003
Title
Denominators
Categories
Title
Measurements
OG0006.82± 0.058
OG0016.78± 0.098
OG0026.81± 0.013
OG003
0
10
6
10
EG001
Tape-secured 24 ga Teflon Catheter
0
11
5
11
EG002
Tegaderm-secured 24 ga Polyurethane Catheter
0
11
9
11
EG003
Tape-secured 24 ga Polyurethane Catheter
0
10
7
10
EG004
Tegaderm-secured 20 ga Teflon Catheter
1
12
9
12
EG005
Tape-secured 20 ga Teflon Catheter
0
12
10
12
EG006
Tegaderm-secured 20 ga Polyurethane Catheter
0
12
10
12
EG007
Tape-secured 20 ga Polyurethane Catheter
0
11
10
11
EG008
SC Button With 27 ga X 9 mm Needle
0
11
8
11
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected11 at risk
EG0030 affected10 at risk
EG0041 affected12 at risk
EG0050 affected12 at risk
EG0060 affected12 at risk
EG0070 affected11 at risk
EG0080 affected11 at risk
EG0003 affected10 at risk
EG0012 affected11 at risk
EG0024 affected11 at risk
EG0032 affected10 at risk
EG0042 affected12 at risk
EG0053 affected12 at risk
EG0062 affected12 at risk
EG0074 affected11 at risk
EG0083 affected11 at risk
Infusion site pain
General disorders
MedDRA (11.0)
Systematic Assessment
EG0002 affected10 at risk
EG0014 affected11 at risk
EG0024 affected11 at risk
EG0033 affected10 at risk
EG0046 affected12 at risk
EG0059 affected12 at risk
EG0068 affected12 at risk
EG0078 affected11 at risk
EG0083 affected11 at risk
Infusion site swelling
General disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected11 at risk
EG0021 affected11 at risk
EG0032 affected10 at risk
EG0043 affected12 at risk
EG0054 affected12 at risk
EG0063 affected12 at risk
EG0070 affected11 at risk
EG0081 affected11 at risk
Headache
Nervous system disorders
MedDRA (11.0)
Non-systematic Assessment
EG0001 affected10 at risk
EG0010 affected11 at risk
EG0021 affected11 at risk
EG0030 affected10 at risk
EG0041 affected12 at risk
EG0051 affected12 at risk
EG0060 affected12 at risk
EG0072 affected11 at risk
EG0080 affected11 at risk
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA (11.0)
Non-systematic Assessment
EG0002 affected10 at risk
EG0011 affected11 at risk
EG0020 affected11 at risk
EG0033 affected10 at risk
EG0041 affected12 at risk
EG0052 affected12 at risk
EG0060 affected12 at risk
EG0070 affected11 at risk
EG0082 affected11 at risk
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
For this study, Baxter requires a review of any planned PI results communications (eg, for confidential information) up to 90 days prior to submission or communication. Baxter may request an additional delay of up to 60 days (eg, to allow for intellectual property protection).