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A Study Evaluating the Persistency of Response With or Without Xolair (Omalizumab) After Long-term Therapy (XPORT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01125748
Recruitment Status : Completed
First Posted : May 18, 2010
Results First Posted : October 15, 2014
Last Update Posted : October 15, 2014
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Allergic Asthma
Interventions: Drug: Omalizumab
Drug: Placebo
Drug: Asthma therapies

  Participant Flow

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 Participants received omalizumab subcutaneously at the same dose and dosing interval as administered prior to enrollment in this study. The dose of omalizumab was either a minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.
Placebo Participants received placebo subcutaneously at the same dosing interval as omalizumab was administered prior to enrollment in this study.

Participant Flow:   Overall Study
    Omalizumab   Placebo
STARTED   88   88 
COMPLETED   78   74 
NOT COMPLETED   10   14 
Adverse Event                0                2 
Lost to Follow-up                0                1 
Physician Decision                8                7 
Patient Decision to Withdraw                2                4 



  Baseline Characteristics

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.
Intent-to-treat population: All randomized participants.

Reporting Groups
  Description
Omalizumab Participants received omalizumab subcutaneously at the same dose and dosing interval as administered prior to enrollment in this study. The dose of omalizumab was either a minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.
Placebo Participants received placebo subcutaneously at the same dosing interval as omalizumab was administered prior to enrollment in this study.
Total Total of all reporting groups

Baseline Measures
   Omalizumab   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 88   88   176 
Age 
[Units: Years]
Mean (Standard Deviation)
 51.14  (11.73)   51.86  (13.25)   51.50  (12.48) 
Gender 
[Units: Participants]
     
Female   63   60   123 
Male   25   28   53 


  Outcome Measures

1.  Primary:   Percentage of Participants Not Experiencing a Protocol-defined Severe Exacerbation During the Study   [ Time Frame: Baseline to the end of the study (up to 52 weeks) ]

2.  Secondary:   Time to the First Protocol-defined Severe Exacerbation   [ Time Frame: Baseline to the end of the study (up to 52 weeks) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

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
Organization: Hoffmann-La Roche
phone: 800 821-8590
e-mail: genentech@druginfo.com



Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT01125748     History of Changes
Other Study ID Numbers: Q4777n
ML01347 ( Other Identifier: Hoffmann-La Roche )
First Submitted: May 14, 2010
First Posted: May 18, 2010
Results First Submitted: October 8, 2014
Results First Posted: October 15, 2014
Last Update Posted: October 15, 2014