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Study of Subcutaneous Hydration Enabled by Human Recombinant Hyaluronidase (Hylenex) (INFUSE-NSLR)

This study has been completed.
Sponsor:
Collaborator:
Baxter Healthcare Corporation
Information provided by:
Halozyme Therapeutics
ClinicalTrials.gov Identifier:
NCT00656370
First received: April 3, 2008
Last updated: April 27, 2010
Last verified: April 2010
History of Changes
Results First Received: February 18, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Healthy
Intervention: Drug: recombinant human hyaluronidase

  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
The first subject entered screening on 19 DEC 2007 and the last subject entered screening on 23 JAN 2008. A total of 25 subjects were assessed for eligibility and signed an Informed Consent Form.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Seven subjects were excluded during screening: 6 did not meet inclusion criteria and 1 withdrew consent. An additional 3 subjects were screened as alternates, but were not enrolled. 15 subjects were randomized and completed stage 1.

Reporting Groups
  Description
NS, LR In Stage 1, the comparison will be NS solution to LR solution. Each subject will receive simultaneous SC infusions of 500 mL (from a 500 mL bag) of solution in each anterior thigh, consisting of NS in one thigh and LR in the other thigh. The thighs (left vs. right) to receive NS and LR will be randomized and double blinded. Immediately prior to the infusions, each thigh will have 150 units of hylenex simultaneously injected.

Participant Flow:   Overall Study
    NS, LR  
STARTED     25 [1]
COMPLETED     15 [2]
NOT COMPLETED     10  
Screen Failures                 7  
Alternates                 3  
[1] 25 subjects were assessed for eligibility and signed an Informed Consent Form.
[2] 15 subjects were randomized and completed stage 1.



  Baseline Characteristics
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Reporting Groups
  Description
NS, LR In Stage 1, the comparison will be NS solution to LR solution. Each subject will receive simultaneous SC infusions of 500 mL (from a 500 mL bag) of solution in each anterior thigh, consisting of NS in one thigh and LR in the other thigh. The thighs (left vs. right) to receive NS and LR will be randomized and double blinded. Immediately prior to the infusions, each thigh will have 150 units of hylenex simultaneously injected.

Baseline Measures
    NS, LR  
Number of Participants  
[units: participants]
 		  15  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     15  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation 		  41  ± 14.9  
Gender  
[units: participants]
 		 
Female     14  
Male     1  
Region of Enrollment  
[units: participants]
 		 
United States     15  



  Outcome Measures
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1.  Primary:   The Subject's Assessment of Discomfort at the Infusion Site on a Visual Analog Scale (VAS).   [ Time Frame: Approximate times which ranged from zero minutes at baseline to maximal post-infusion of 240 minutes. ]
  Show Outcome Measure 1

2.  Secondary:   Safety Assessment of 15 Participants Who Were Included in the Safety Data Set.   [ Time Frame: Baseline, Mid-Infusion Right and Left, Post-Infusion Right and Left, Discharge Right and Left ]
  Show Outcome Measure 2

3.  Secondary:   Average Infusion Flow Rate (mL/hr) Derived From the Time to Infuse up to 500mL of Solution   [ Time Frame: During infusion ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Change in Circumference of the Thigh at the Infusion Site   [ Time Frame: Before the infusion, during the infusion, after the infusion, and discharge ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Time From the Beginning of Infusion Until the Thigh Circumference Returns to Within 5% of Baseline Circumference.   [ Time Frame: Before the infusion until discharge ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Subject's Global Preference for Infusion (Left vs. Right Thigh)   [ Time Frame: End of infusion ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  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:
unchecked 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.
unchecked 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.


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
No text entered.  


Results Point of Contact:  
Name/Title: Jonathan Leff, M.D., Chief Medical Officer
Organization: Halozyme Therapeutics Incorporated
phone: 858-704-8177
e-mail: jleff@halozyme.com


No publications provided


Responsible Party: Jonathan Leff, M.D., Halozyme Therapeutics
ClinicalTrials.gov Identifier: NCT00656370     History of Changes
Other Study ID Numbers: HZ2-07-03
Study First Received: April 3, 2008
Results First Received: February 18, 2010
Last Updated: April 27, 2010
Health Authority: United States: Food and Drug Administration