AsthmaPhase 3NCT00109187
An Extension Study of Xolair in Moderate to Severe, Persistent Asthma Patients Who Completed Study Q2143g
A Phase 3 study testing Xolair (omalizumab) in people with Asthma, run by Genentech, Inc..
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Asthma
- What is being tested?
- Xolair (omalizumab)
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2002to Apr 2003
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 9Show fewer
- History of noncompliance with medical regimens
- Current participation in a study using an investigational new drug other than Xolair
- Participation in Study Q2195g
About this study
Official title: Open-Label Extension Study II of Xolair (Omalizumab) in Moderate to Severe, Persistent Asthma Subjects Who Completed Study Q2143g (ALTO)
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.
- Conditions
- Asthma
- Being tested
- Xolair (omalizumab)
- Keywords
- Moderate Persistent Asthma, Severe Persistent Asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xolair (omalizumab)Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2005 (estimated)
- Study startJun 2002
- Study completionApr 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Masking
- None (open label)
- Enrolment
- 0 participants
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00109187
- Sponsor's protocol ID
- Q2461g
- Status last verified
- Jun 2013
- First submitted
- 26 Apr 2005
- Last updated
- 21 Jun 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label Extension Study II of Xolair (Omalizumab) in Moderate to Severe, Persistent Asthma Subjects Who Completed Study Q2143g (ALTO)
- ClinicalTrials.gov ID
- NCT00109187
- Acronym / sponsor ID
- Q2461g
- Conditions
- Asthma
- Keywords
- Moderate Persistent Asthma, Severe Persistent Asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 0 participants
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2002
- Study completion
- Apr 2003 (actual)
- First posted
- 26 Apr 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xolair (omalizumab) | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Xolair (omalizumab) in people with Asthma, run by Genentech, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2013.