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Switchover Trial From Imiglucerase to Plant Cell Expressed Recombinant Human Glucocerebrosidase

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Protalix
ClinicalTrials.gov Identifier:
NCT00712348
First received: July 7, 2008
Last updated: May 30, 2014
Last verified: May 2014
Results First Received: April 30, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Gaucher Disease
Intervention: Drug: Taliglucerase alfa

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Taliglucerase Alfa

Open label taliglucerase alfa treatment

Taliglucerase alfa: Intravenous infusion every 2 weeks


Participant Flow:   Overall Study
    Taliglucerase Alfa  
STARTED     31  
COMPLETED     30  
NOT COMPLETED     1  
Withdrawal by Subject                 1  



  Baseline Characteristics
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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
Taliglucerase Alfa

Open label taliglucerase alfa treatment

Taliglucerase alfa: Intravenous infusion every 2 weeks


Baseline Measures
    Taliglucerase Alfa  
Number of Participants  
[units: participants]
  31  
Age  
[units: participants]
 
<=18 years     5  
Between 18 and 65 years     25  
>=65 years     1  
Age  
[units: years]
Mean ± Standard Deviation
  41.6  ± 17.4  
Gender  
[units: participants]
 
Female     14  
Male     17  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     0  
Native Hawaiian or Other Pacific Islander     1  
Black or African American     0  
White     30  
More than one race     0  
Unknown or Not Reported     0  
Region of Enrollment  
[units: participants]
 
United States     7  
Canada     1  
Spain     4  
Australia     3  
Israel     9  
United Kingdom     2  
Serbia     4  
Singapore     1  
Religion  
[units: participants]
 
JEWISH - ASHKENAZI     14  
JEWISH - NONASHKENAZI     0  
NON JEWISH     15  
UNREPORTED     2  



  Outcome Measures
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1.  Primary:   Hemoglobin   [ Time Frame: Every 3 months from Baseline to Month 9 ]

2.  Other Pre-specified:   Platelet Count   [ Time Frame: Every 3 months from Baseline to Month 9 ]

3.  Other Pre-specified:   Spleen Volume   [ Time Frame: Baseline and 9 Months ]

4.  Other Pre-specified:   Liver Volume   [ Time Frame: Baseline and 9 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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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 NOT 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.


Results Point of Contact:  
Name/Title: VP Medical Affairs
Organization: Protalix Ltd.
phone: +972-4-9028100
e-mail: raul@protalix.com


No publications provided


Responsible Party: Protalix
ClinicalTrials.gov Identifier: NCT00712348     History of Changes
Other Study ID Numbers: PB-06-002
Study First Received: July 7, 2008
Results First Received: April 30, 2014
Last Updated: May 30, 2014
Health Authority: United States: Food and Drug Administration
Israel: Ministry of Health