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Trial record 7 of 38 for:    "Hereditary angioedema" | United States

A Study to Evaluate the Safety and Pharmacology of Subcutaneous Administration of CINRYZE With Recombinant Human Hyaluronidase

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ClinicalTrials.gov Identifier: NCT01426763
Recruitment Status : Completed
First Posted : August 31, 2011
Results First Posted : January 4, 2013
Last Update Posted : April 15, 2014
Sponsor:
Collaborator:
Halozyme Therapeutics
Information provided by (Responsible Party):
Shire

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label)
Condition: Hereditary Angioedema
Intervention: Biological: CINRYZE with rHuPH20

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
SC CINRYZE With rHuPH20 Dose Level 1 Subcutaneous (SC) injection of 1000 Units of CINRYZE with 20,000 Units of recombinant human hyaluronidase (rHuPH20) twice weekly for two weeks
SC CINRYZE With rHuPH20 Dose Level 2 Subcutaneous injection of 2000 Units of CINRYZE with 40,000 Units of rHuPH20 twice weekly for two weeks

Participant Flow:   Overall Study
    SC CINRYZE With rHuPH20 Dose Level 1   SC CINRYZE With rHuPH20 Dose Level 2
STARTED   6   6 
COMPLETED   6   6 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
SC CINRYZE With rHuPH20 Dose Level 1 Subcutaneous injection of 1000 Units of CINRYZE with 20,000 Units of rHuPH20 twice weekly for two weeks
SC CINRYZE With rHuPH20 Dose Level 2 Subcutaneous injection of 2000 Units of CINRYZE with 40,000 Units of rHuPH20 twice weekly for two weeks
Total Total of all reporting groups

Baseline Measures
   SC CINRYZE With rHuPH20 Dose Level 1   SC CINRYZE With rHuPH20 Dose Level 2   Total 
Overall Participants Analyzed 
[Units: Participants]
 6   6   12 
Age 
[Units: Years]
Mean (Standard Deviation)
 31.5  (7.79)   33.7  (10.27)   32.6  (8.76) 
Gender 
[Units: Participants]
     
Female   3   4   7 
Male   3   2   5 


  Outcome Measures

1.  Primary:   Incidence and Severity of Adverse Events, Number of Subjects With Local Injection Site Reactions, and Number of Subjects Who Discontinue Study Drug or Withdraw From the Study   [ Time Frame: 18 days ]

2.  Secondary:   C1 Inhibitor (C1 INH) and C4 Levels   [ Time Frame: 18 days ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

3.  Secondary:   Number of Subjects With C1 INH Antibodies   [ Time Frame: Through 30 days after final dose ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  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.


  More Information

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.


Results Point of Contact:  
Name/Title: Chief Scientific Officer
Organization: ViroPharma
phone: 610-458-7300



Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01426763     History of Changes
Other Study ID Numbers: 0624-204
First Submitted: August 25, 2011
First Posted: August 31, 2011
Results First Submitted: November 30, 2012
Results First Posted: January 4, 2013
Last Update Posted: April 15, 2014