Study of Subcutaneous Rehydration With Recombinant Human Hyaluronidase for Infants and Children

NCT00477152 | Completed Phase 4 Results

• 1 other identifier: 1838-003
• Study Type: interventional
• Target: 52
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of the study is to evaluate the safety, effectiveness and ease of use of subcutaneous (SC) rehydration using HYLENEX-augmented SC infusion of fluids and electrolytes for the rehydration of pediatric patients with mild to moderate dehydration.

Conditions

Dehydration

Keywords

dehydration; fluid therapy; pediatrics; emergency medicine; hyaluronoglucosaminidase; hyaluronidase; hypodermoclysis; clysis; subcutaneous hydration; subcutaneous rehydration; hyaluronan; rHuPH20

Outcome Measures

Primary Outcomes (2)

• HYLENEX-facilitated Subcutaneous (SC) Rehydration Success

  Successfully rehydrated (as medically judged by treating physician) without rescue therapy (ie, without receiving fluids via an alternate route), and discharged to home

  At emergency department discharge (mean time to discharge = 7.03 ± 7.57 hr)

• Modified HYLENEX-facilitated Subcutaneous (SC) Rehydration Success

  Successfully rehydrated (as medically judged by treating physician) without rescue therapy (ie, without receiving fluids via an alternate route), regardless of emergency department discharge destination

  At emergency department discharge (mean time to discharge = 7.03 ± 7.57 hr)

Secondary Outcomes (2)

• Number of Attempts Needed to Successfully Place Subcutaneous (SC) Catheter

  At end of placement of SC catheter

• Post-treatment Gorelick Dehydration Score

  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)

Study Arms (1)

HYLENEX-augmented subcutaneous (SC ) rehydration

EXPERIMENTAL

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.

Drug: hyaluronidase (human recombinant)/rehydration fluid

Interventions

hyaluronidase (human recombinant)/rehydration fluid DRUG

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.

Also known as: HYLENEX recombinant

HYLENEX-augmented subcutaneous (SC ) rehydration

Eligibility Criteria

• Age: 2 Months - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Child, 2 months to 10 years of age
• Body weight less than 42 kg
• Presenting at emergency department with mild to moderate dehydration (Gorelick dehydration classification: presence of 1 to 6 \[of possible 10\] moderate or severe signs and symptoms) requiring parenteral rehydration

You may not qualify if:

• In shock or life-threatening situation (other than dehydration)
• Severe dehydration
• Requires intravenous (IV) therapy for another indication
• Indwelling IV catheter (excepting one intended strictly for clinical laboratory sample collection)
• Already received rehydration therapy IV within prior 48 hours or substantial oral fluid immediately before enrollment
• Condition precluding subcutaneous injection or infusion site evaluation in anterior thigh or other elected infusion site
• Reason for hospital admission or extended emergency department stay other than dehydration
• Known hypersensitivity to hyaluronidase or another ingredient in HYLENEX
• Hyponatremia or hypernatremia
• Hypokalemia
• Medical condition likely to interfere with ability to fully complete study or have protocol-specified assessments
• Medical history, screening examination finding or historical clinical laboratory result precluding safe participation in study or which might adversely effect interpretation of study results
• Participated in study of any investigational drug or device within 30 days prior to this study

Sponsors & Collaborators

• Baxter Healthcare Corporation: lead
• Halozyme Therapeutics: collaborator
• PPD Development, LP: collaborator

Related Publications (2)

• 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. doi: 10.1542/peds.99.5.e6.

  PMID: 9113963 BACKGROUND

• 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. doi: 10.1542/peds.2008-3588. Epub 2009 Oct 5.

  PMID: 19805455 RESULT

MeSH Terms

Conditions

Dehydration

Interventions

Hyaluronoglucosaminidase

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glycoside Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Polysaccharide-Lyases; Carbon-Oxygen Lyases; Lyases

Results Point of Contact

• Title: George Harb, MD, MPH
• Organization: Baxter Halthcare Corporation

george_harb@baxter.com

Study Officials

• George E Harb, MD

  Baxter Healthcare Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2007
• First Posted: May 22, 2007
• Study Start: August 1, 2007
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: December 1, 2011
• Results First Posted: November 23, 2011

Record last verified: 2011-11