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

This study has been completed.
Sponsor:
Information provided by:
Genentech
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.
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)
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 ]

Measure Type Primary
Measure Title Serious Adverse Events
Measure Description All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0. An SAE is defined as an adverse event that results in death, is life threatening, requires hospitalization, results in significant disability, results in birth defect, or is considered a significant medical event by the investigator
Time Frame Through Week 52  
Safety Issue Yes  

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.
Safety-analysis population

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)

Measured Values
    Omalizumab (Placebo in Q2788g)     Omalizumab (Omalizumab in Q2788g)  
Number of Participants Analyzed  
[units: participants]
  4     7  
Serious Adverse Events  
[units: participants]
   
Overdose     0     1  
Depression     0     1  

No statistical analysis provided for Serious Adverse Events



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

Measure Type Secondary
Measure Title Food Allergen Exposure, Assessed on Patient-reported Questionnaire
Measure Description Participants were asked to record every 4 weeks in the food-related allergic event questionnaire: "Whether you were exposed to peanut, tree nut (cashew, almond, etc.), shellfish (shrimp, crab, etc.), eggs, milk, or other (please specify)" and "Did you have a reaction? (Yes/No)."
Time Frame Every 4 weeks through Week 52  
Safety Issue No  

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 (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)

Measured Values
    Omalizumab (Placebo in Q2788g)     Omalizumab (Omalizumab in Q2788g)  
Number of Participants Analyzed  
[units: participants]
  4     7  
Food Allergen Exposure, Assessed on Patient-reported Questionnaire  
[units: participants]
   
Peanut     1     3  

No statistical analysis provided for Food Allergen Exposure, Assessed on Patient-reported Questionnaire



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

Measure Type Secondary
Measure Title Food-allergic Reactions As Assessed by the Ewan Scale
Measure Description The Ewan scale has five ascending grades of severity from "Grade 1" to "Grade 5" (as well, there is a possible value of "Not Applicable"). Following a report of an allergic reaction to food on a patient-reported questionnaire, the reaction is graded by the study coordinator or Principle Investigator
Time Frame Through Week 52  
Safety Issue No  

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.
safety-evaluable population

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)

Measured Values
    Omalizumab (Placebo in Q2788g)     Omalizumab (Omalizumab in Q2788g)  
Number of Participants Analyzed  
[units: participants]
  4     7  
Food-allergic Reactions As Assessed by the Ewan Scale  
[units: participants]
   
Grade 1     0     1  
Grade 2     0     0  
Grade 3     1     2  
Grade 4     0     0  
Grade 5     0     0  

No statistical analysis provided for Food-allergic Reactions As Assessed by the Ewan Scale



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

Measure Type Secondary
Measure Title Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs
Measure Description All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0. All AEs that do not meet any of the criteria for serious should be regarded as nonserious AEs.
Time Frame Through Week 52  
Safety Issue No  

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.
safety-evaluable population

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)

Measured Values
    Omalizumab (Placebo in Q2788g)     Omalizumab (Omalizumab in Q2788g)  
Number of Participants Analyzed  
[units: participants]
  4     7  
Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs  
[units: participants]
   
Lymphadenopathy     0     1  
Motion Sickness     0     1  
Tinnitus     0     1  
Diarrhoea     0     2  
Abdominal Pain     0     2  
Nausea     0     2  
Vomiting     0     1  
Lip Swelling     0     1  
Oral Pruritis     0     1  
Pyrexia     0     2  
Injection Site Bruising     1     1  
Fatigue     0     1  
Nasopharyngitis     0     2  
Laryngitis     0     1  
Sinusitis     0     1  
Upper Respiratory Tract Infection     1     0  
Pharyngitis Streptococcal     1     1  
Gastroenteritis     0     1  
Otitis Media     0     1  
Localised Infection     0     1  
Anorexia     0     1  
Arthralgia     1     0  
Loss of Consciousness     0     1  
Headache     0     1  
Migraine     0     1  
Dizziness     0     1  
Hypoaesthesia     0     1  
Menstruation Irregular     1     0  
Cough     0     3  
Nasal Congestion     0     2  
Rhinitis Allergic     1     0  
Asthma     0     2  
Pharyngolaryngeal Pain     0     2  
Rhinorrhoea     0     1  
Throat Irritation     0     1  
Eczema     1     1  
Rash     0     1  

No statistical analysis provided for Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs




  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