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Efficacy Study of DX-88 (Ecallantide) to Treat Acute Attacks of Hereditary Angioedema (HAE)

This study has been completed.
Sponsor:
Information provided by:
Dyax Corp.
ClinicalTrials.gov Identifier:
NCT00457015
First received: April 4, 2007
Last updated: April 9, 2010
Last verified: April 2010
History of Changes
Results First Received: December 30, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Hereditary Angioedema
Interventions: Drug: ecallantide
Drug: Phosphate Buffer Saline (PBS), pH 7.0

  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
n/a

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients were screened in advance of presenting with an HAE attack but were randomized only upon attack.

Reporting Groups
  Description
KALBITOR (Ecallantide) KALBITOR (ecallantide, DX-88) 30 mg given as three 10 mg/mL subcutaneous injections.
Placebo Placebo, Phosphate Buffer Saline (PBS), pH 7.0 given as 3 subcutaneous injections.

Participant Flow:   Overall Study
    KALBITOR (Ecallantide)     Placebo  
STARTED     48     48  
COMPLETED     48     47  
NOT COMPLETED     0     1  
Left study site against medical advice                 0                 1  



  Baseline Characteristics
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Reporting Groups
  Description
KALBITOR (Ecallantide) KALBITOR (ecallantide, DX-88) 30 mg given as three 10 mg/mL subcutaneous injections.
Placebo Placebo, Phosphate Buffer Saline (PBS), pH 7.0 given as 3 subcutaneous injections.
Total Total of all reporting groups

Baseline Measures
    KALBITOR (Ecallantide)     Placebo     Total  
Number of Participants  
[units: participants]
 		  48     48     96  
Age  
[units: years]
Mean ± Standard Deviation 		  37.0  ± 13.12     38.0  ± 12.19     37.5  ± 12.61  
Gender  
[units: participants]
 		     
Female     37     28     65  
Male     11     20     31  
Region of Enrollment  
[units: participants]
 		     
United States     47     48     95  
Canada     1     0     1  
Symptom Complexes at Baseline [1]
[units: symptom complexes]
 		     
Internal Head/Neck     8     13     21  
Stomach/GI     18     27     45  
Genital/Buttocks     6     5     11  
External Head/Neck     14     9     23  
Cutaneous     34     21     55  
[1] More than one baseline symptom complex could be reported per patient; hence the number of complexes is greater than the number of patients in each group. Patient were to have at least one symptom complex that was moderate or severe. The total number of symptom complexes was 155.



  Outcome Measures
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1.  Primary:   Change From Baseline in Mean Symptom Complex Severity (MSCS) Score at 4 Hours Post-dose   [ Time Frame: baseline, 4 hours post-dose ]
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2.  Secondary:   Treatment Outcome Score at 4 Hours Post-Dose   [ Time Frame: 4 hours post-dose ]
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3.  Secondary:   Patients With Significant Improvement in Overall Response   [ Time Frame: 4 hours post-dose ]
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4.  Secondary:   Patients With a Successful Response at 4 Hours Post-dosing, Based on the Change From Baseline in the MSCS Score   [ Time Frame: baseline, 4 hours post-dosing ]
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5.  Secondary:   Proportion of Patients Maintaining a Significant Improvement in Overall Response Through 24 Hours   [ Time Frame: 24 hours post-dosing ]
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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:
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: Patrick T Horn
Organization: Dyax Corp.
phone: 617 250 5948
e-mail: phorn@dyax.com


No publications provided by Dyax Corp.

Publications automatically indexed to this study:


Responsible Party: Bill Pullman, MD, PhD, Executive Vice President, Chief Development Officer, Dyax Corp.
ClinicalTrials.gov Identifier: NCT00457015     History of Changes
Other Study ID Numbers: EDEMA4 (DX-88/20)
Study First Received: April 4, 2007
Results First Received: December 30, 2009
Last Updated: April 9, 2010
Health Authority: United States: Food and Drug Administration