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CompletedNCT00109187Updated Jun 21, 2013

An Extension Study of Xolair in Moderate to Severe, Persistent Asthma Patients Who Completed Study Q2143g

A Phase 3 interventional study of Xolair (omalizumab) in Asthma, sponsored by Genentech, Inc.. Completed. Per ClinicalTrials.gov, last updated 2013-06-21.

Sponsored by Genentech, Inc. (part of Hoffmann-La Roche) · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
0
Sex
All
01

Study summary

This is a Phase IIIb, multicenter, open-label, extension study available to subjects who successfully complete Study Q2143g and have not participated in Study Q2195g. Subjects should be registered via the IVRS (Interactive Voice Response System) within 48 hours prior to their baseline visit. All subjects in this study will be treated with Xolair for 24 weeks. Subjects in the New Treatment Group may require additional visits for study drug injections (as frequently as every 2 weeks). Data collection during these additional visits will be limited to the assessment of adverse events. The study will evaluate all serious and nonserious adverse events, laboratory assessments, data on asthma exacerbations, and concomitant medication usage.

02

Conditions studied

  • Asthma

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Keywords

  • Moderate Persistent Asthma
  • Severe Persistent Asthma
03

In context

Asthma

4,010 studies on the registry are indexed under Asthma; 514 are open to participants now.

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Lead sponsor

Genentech, Inc. is the lead sponsor of 517 studies on the registry; 22 are open to participants now.

Of its 95 completed or terminated interventional studies of FDA-regulated products, 52 (55%) have results posted.

First submitted after Genentech, Inc. became part of Hoffmann-La Roche.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Successful completion of the 24-week study period in Study Q2143g
  • Signed informed consent (in the case of a minor, consent must be given by the child's parent or legally authorized representative)
  • For subjects who have never received Xolair, a serum IgE level >=30 IU/mL and \<=1300 IU/mL and have a body weight >=20 kg and \<=150 kg
  • Females of childbearing potential must, in the opinion of the investigator, be using an effective method of contraception to prevent pregnancy and agree to continue to practice an acceptable method of contraception for the duration of their participation in the study.

Exclusion criteria

Exclusion Criteria:

  • Thrombocytopenia as evidenced by a platelet count of \<100,000/uL
  • Pregnant or breastfeeding
  • Significant systemic disease (e.g., infection, hematologic, renal, hepatic, coronary heart disease or other cardiovascular diseases, endocrine or gastrointestinal disease) within the previous 3 months
  • History of neoplasia
  • Any systemic condition requiring regular administration of an immunoglobulin
  • Known hypersensitivity to any ingredients of Xolair, including excipients (sucrose, histidine, polysorbate 20)
  • History of noncompliance with medical regimens
  • Current participation in a study using an investigational new drug other than Xolair
  • Participation in Study Q2195g
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Masking
None (open label)
Enrollment
0 participants

Interventions

06

Study locations

No study locations are listed for this record.

07

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 2002 and a completion of Apr 2003. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 26, 2005
First posted
Apr 26, 2005
Start
Jun 2002
CompletionActual
Apr 2003
Last update
Jun 21, 2013
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 21, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00109187
Lead sponsor
Genentech, Inc.
Responsible party
Sponsor
First posted
Apr 26, 2005
Start date
Jun 2002
Completion
Apr 2003
Last update
Jun 21, 2013
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.

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Discussion

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