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.
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
  Show All Outcome Measures

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 ]
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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
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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: Medical Communications Specialist
Organization: Genentech, Inc.
phone: 800-821-8590


No publications provided


Responsible Party: Clinical Trials Posting Group, Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00382148     History of Changes
Other Study ID Numbers: Q3623g
Study First Received: September 26, 2006
Results First Received: November 5, 2009
Last Updated: November 12, 2009
Health Authority: United States: Food and Drug Administration