Subcutaneous Rehydration Compared to Intravenous Rehydration (PEDs-II)

Halozyme

Status and phase

Completed

Phase 4

Conditions

Dehydration

Treatments

Drug: recombinant human hyaluronidase

Study type

Interventional

Funder types

Industry

Identifiers

NCT00773175

HZ2-08-03

Details and patient eligibility

About

Randomized (1:1 ratio) study of subcutaneous (SC) versus intravenous (IV) fluid rehydration in mildly to moderately dehydrated pediatric patients.

Full description

This is a prospective, randomized (1:1 ratio), open-label, parallel group, multicenter, multi-national, study of SC versus IV fluid rehydration in mildly to moderately dehydrated pediatric patients treated in the Emergency Department (ED), inpatient pediatric unit, and/or outpatient urgent care facility. It is expected that up to 186 patients, in order to achieve 148 evaluable patients, will be randomized in a 1:1 ratio to receive isotonic fluid rehydration by either SC administration with hylenex (150 Units) or IV without hylenex.

Enrollment

148 patients

Sex

All

Ages

30 days to 10 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Children of either gender from one month to ≤10 years of age.
Patients with mild or moderate dehydration
Healthy child except for the underlying etiology for dehydration
Pre-dehydration body weight ≥ 5th percentile for age
Parents or legal guardian(s) available to provide informed consent.

Exclusion criteria

Severe dehydration
Shock or life-threatening situation (life expectancy < 10 days).
Requirement for IV access for any indication other than for treatment of dehydration.
Indwelling IV catheter, except for one intended only for collection of clinical laboratory specimens.
Any condition precluding SC infusion or infusion site evaluation
Any reason (prior to study enrollment) for a hospital admission or an extended stay in the ED for other than dehydration.
Known hypersensitivity to hyaluronidase or hylenex.
Known hyponatremia (< 130 milliequivalents per liter [mEq/L]) or hypernatremia (> 155 mEq/L).
Known hypokalemia (< 3.0 mEq/L).
Any medical condition likely to interfere with the patient's ability to fully complete all protocol-specified interventions, the ability to undergo all protocol-specified assessments, or likely to prolong the patient's need for medical attention beyond that required for treatment of dehydration.
Participation in an investigational drug or device study within 30 days prior to enrollment in this study.