Study of Subcutaneous Rehydration With Recombinant Human Hyaluronidase for Infants and Children (INFUSE-PR)

This study has been completed.

Sponsor:

Collaborators:

Halozyme Therapeutics

PPD

Information provided by (Responsible Party):

Baxter Healthcare Corporation

ClinicalTrials.gov Identifier:

NCT00477152

First received: May 18, 2007

Last updated: November 22, 2011

Last verified: November 2011

History of Changes

Results First Received: September 12, 2011

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Dehydration
Intervention:	Drug: hyaluronidase (human recombinant)/rehydration fluid

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects recruited in emergency department after presenting with signs of mild to moderate dehydration

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
HYLENEX-augmented Subcutaneous (SC) Rehydration	Single 150 U subcutaneous (SC) HYLENEX dose administered immediately prior to start of SC infusion of rehydration fluid. Additional 150 U HYLENEX dose to be administered prior to any additional fluid infusion beyond 24 hours.

Participant Flow: Overall Study

	HYLENEX-augmented Subcutaneous (SC) Rehydration
STARTED	52 ^[1]
COMPLETED	49 ^[2]
NOT COMPLETED	3
Parent withdrew consent	2
Adverse Event	1

[1]	One patient withdrawn prior to treatment, so not included in analyses.
[2]	Two patients treated, but assessments incomplete. All available data included in analyses for these.

Baseline Characteristics

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Outcome Measures

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1. Primary:

HYLENEX-facilitated Subcutaneous (SC) Rehydration Success [ Time Frame: At emergency department discharge (mean time to discharge = 7.03 ± 7.57 hr) ]

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2. Primary:

Modified HYLENEX-facilitated Subcutaneous (SC) Rehydration Success [ Time Frame: At emergency department discharge (mean time to discharge = 7.03 ± 7.57 hr) ]

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3. Secondary:

Number of Attempts Needed to Successfully Place Subcutaneous (SC) Catheter [ Time Frame: At end of placement of SC catheter ]

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4. Secondary:

Post-treatment Gorelick Dehydration Score [ Time Frame: At baseline and at either the end of subcutaneous infusion (mean duration = 5.73 ± 9.15 hr) or emergency department discharge (mean time to discharge = 7.03 ± 7.57 hr) ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Baxter's agreements with PIs vary per individual PI, but contain common elements. For this study, PIs are restricted from independently publishing results until the earlier of the primary multicenter publication or 1 year after study completion. Baxter requires a review of 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).

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: George Harb, MD, MPH
Organization: Baxter Halthcare Corporation
e-mail: george_harb@baxter.com

Publications of Results:

Allen CH, Etzwiler LS, Miller MK, Maher G, Mace S, Hostetler MA, Smith SR, Reinhardt N, Hahn B, Harb G; INcreased Flow Utilizing Subcutaneously-Enabled Pediatric Rehydration Study Collaborative Research Group. Recombinant human hyaluronidase-enabled subcutaneous pediatric rehydration. Pediatrics. 2009 Nov;124(5):e858-67. Epub 2009 Oct 5.

Other Publications:

Gorelick MH, Shaw KN, Murphy KO. Validity and reliability of clinical signs in the diagnosis of dehydration in children. Pediatrics. 1997 May;99(5):E6.

Responsible Party:	Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:	NCT00477152 History of Changes
Other Study ID Numbers:	1838-003
Study First Received:	May 18, 2007
Results First Received:	September 12, 2011
Last Updated:	November 22, 2011
Health Authority:	United States: Food and Drug Administration

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