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A Study of Xolair in Peanut-Allergic Subjects Previously Enrolled in Study Q2788g

This study has been completed.
Sponsor:
Information provided by:
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT00382148
First received: September 26, 2006
Last updated: November 12, 2009
Last verified: November 2009
Results First Received: November 5, 2009  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Peanut Hypersensitivity
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 (Placebo in Q2788g) Either a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks or 0.008 mg/kg/IgE (IU/mL) every 2 weeks (based on dosing table)
Omalizumab (Omalizumab in Q2788g) Either a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks or 0.008 mg/kg/IgE (IU/mL) every 2 weeks (based on dosing table)

Participant Flow:   Overall Study
    Omalizumab (Placebo in Q2788g)     Omalizumab (Omalizumab in Q2788g)  
STARTED     4     7  
COMPLETED     3     7  
NOT COMPLETED     1     0  



  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.
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Reporting Groups
  Description
Omalizumab (Placebo in Q2788g) Either a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks or 0.008 mg/kg/IgE (IU/mL) every 2 weeks (based on dosing table)
Omalizumab (Omalizumab in Q2788g) Either a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks or 0.008 mg/kg/IgE (IU/mL) every 2 weeks (based on dosing table)
Total Total of all reporting groups

Baseline Measures
    Omalizumab (Placebo in Q2788g)     Omalizumab (Omalizumab in Q2788g)     Total  
Number of Participants  
[units: participants]
  4     7     11  
Age, Customized [1]
[units: participants]
     
6 to < 12     0     2     2  
>= 12     4     5     9  
Age  
[units: years]
Mean ± Standard Deviation
  32.0  ± 23.5     17.3  ± 8.9     22.6  ± 16.4  
Gender  
[units: participants]
     
Female     2     2     4  
Male     2     5     7  
[1] Safety-analysis population



  Outcome Measures
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1.  Primary:   Serious Adverse Events   [ Time Frame: Through Week 52 ]

2.  Secondary:   Food Allergen Exposure, Assessed on Patient-reported Questionnaire   [ Time Frame: Every 4 weeks through Week 52 ]

3.  Secondary:   Food-allergic Reactions As Assessed by the Ewan Scale   [ Time Frame: Through Week 52 ]

4.  Secondary:   Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs   [ Time Frame: Through Week 52 ]


  Serious Adverse Events
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Time Frame No text entered.
Additional Description No text entered.

Reporting Groups
  Description
Omalizumab (Placebo in Q2788g) Either a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks or 0.008 mg/kg/IgE (IU/mL) every 2 weeks (based on dosing table)
Omalizumab (Omalizumab in Q2788g) Either a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks or 0.008 mg/kg/IgE (IU/mL) every 2 weeks (based on dosing table)

Serious Adverse Events
    Omalizumab (Placebo in Q2788g)     Omalizumab (Omalizumab in Q2788g)  
Total, serious adverse events      
# participants affected / at risk     0/4 (0.00%)     1/7 (14.29%)  
Injury, poisoning and procedural complications      
Overdose 1    
# participants affected / at risk     0/4 (0.00%)     1/7 (14.29%)  
Psychiatric disorders      
Depression 1    
# participants affected / at risk     0/4 (0.00%)     1/7 (14.29%)  
1 Term from vocabulary, MedDRA (10.0)




  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