Open Label Study to Assess Safety and Immunogenicity of Omalizumab Liquid Formulation.

This study has been completed.
Sponsor:
Collaborators:
Genentech, Inc.
Tanox
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00500539
First received: July 11, 2007
Last updated: May 31, 2011
Last verified: May 2011
Results First Received: November 17, 2010  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Asthma
Intervention: Drug: omalizumab

  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
No text entered.

Reporting Groups
  Description
Omalizumab The determined dose was injected subcutaneously every 2 weeks or every 4 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level; a dosing table was used.

Participant Flow for 2 periods

Period 1:   Treatment Period (24 Weeks)
    Omalizumab  
STARTED     155  
COMPLETED     140  
NOT COMPLETED     15  
Adverse Event                 4  
Unsatisfactory therapeutic effect                 1  
Subject withdrew consent                 1  
Lost to Follow-up                 2  
Administrative problems                 2  
Protocol Deviation                 5  

Period 2:   Follow-up Period (16 Weeks)
    Omalizumab  
STARTED     148 [1]
COMPLETED     136  
NOT COMPLETED     12  
Adverse Event                 1  
Subject withdrew consent                 2  
Lost to Follow-up                 3  
Administrative problems                 1  
Death                 1  
Protocol Deviation                 1  
Missing                 3  
[1] Participants could discontinue study drug and still enter the follow-up period.



  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
Omalizumab The determined dose was injected subcutaneously every 2 weeks or every 4 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level; a dosing table was used.

Baseline Measures
    Omalizumab  
Number of Participants  
[units: participants]
  155  
Age  
[units: participants]
 
<=18 years     13  
Between 18 and 65 years     135  
>=65 years     7  
Age  
[units: years]
Mean ± Standard Deviation
  42.7  ± 14.32  
Gender  
[units: participants]
 
Female     95  
Male     60  



  Outcome Measures
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1.  Primary:   The Number of Participants With Confirmed Positive Human Antihuman Antibody (HAHA) Results at the End of the 16-week Follow-up Period   [ Time Frame: 16 weeks after last dose ]

2.  Secondary:   Number of Participants Who Experienced Adverse Events (AEs) and Serious Adverse Events (SAEs) During the Treatment Period   [ Time Frame: 24 weeks treatment period + 4 weeks for following up participants ]

3.  Secondary:   Number of Participants Who Experienced Adverse Events (AEs) and Serious Adverse Events (SAEs) During the Follow-up Period   [ Time Frame: Last 12 weeks of the follow-up period (initial 4 weeks of the follow-up period were included in the treatment period for AE reporting) ]


  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 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: Study Director
Organization: Novartis Pharmaceuticals
phone: 862-778-8300


No publications provided by Novartis

Publications automatically indexed to this study:

Responsible Party: external affairs, Novartis
ClinicalTrials.gov Identifier: NCT00500539     History of Changes
Other Study ID Numbers: CIGE025C2303
Study First Received: July 11, 2007
Results First Received: November 17, 2010
Last Updated: May 31, 2011
Health Authority: United States: Food and Drug Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Germany: Paul-Ehrlich-Institut
Spain: Spanish Agency of Medicines