AsthmaEXPECTNCT00373061
An Observational Study of the Use and Safety of Xolair® During Pregnancy
An observational study of Asthma, run by Genentech, Inc. at 1 site in United States.
Trial summary
The Xolair® Pregnancy Registry is an observational study established by Genentech to obtain data on pregnancy outcomes in women who are exposed to Xolair®. Women exposed to at least one dose of Xolair® within 8 weeks prior to conception or at any time during their pregnancy will be followed to completion of their… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Asthma
- What is being tested?
- Xolair®
- How many people
- 309 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Oct 2006to 5 Jan 2018
- Phase
- Observational
- 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
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Women exposed to at least one dose of Xolair® within 8 weeks prior to conception or at any time during their pregnancy. Enrollment in the Xolair® Pregnancy Registry is voluntary and must be initiated by the pregnant woman. A healthcare provider cannot enroll a patient but can suggest that the pregnant woman call the Registry Center to enroll herself.
Who may be able to join
- Women who have been exposed to at least one dose of Xolair® (whether inadvertent or deliberate) within 8 weeks prior to conception or during pregnancy
Who cannot join
- Women not currently pregnant
- Women exposed to Xolair® not during pregnancy but only while breastfeeding
- Re-enrollment of women who are pregnant for second (or more) time is not allowed
Trial locations and contacts
1 site in 1 country.
United States1 site
Ppd Development, Llc
Morrisville, North Carolina, 27560-7200
About this study
Official title: The Xolair® Pregnancy Registry: An Observational Study of the Use and Safety of Xolair® (Omalizumab) During Pregnancy
The Xolair® Pregnancy Registry is an observational study established by Genentech to obtain data on pregnancy outcomes in women who are exposed to Xolair®. Women exposed to at least one dose of Xolair® within 8 weeks prior to conception or at any time during their pregnancy will be followed to completion of their pregnancies. The evaluation of infants will be conducted at birth and at 6-month intervals until the infants are 12 months old. Follow-up of the infant will be extended until the infant is 18 months old, if the woman continues Xolair® treatment while breastfeeding.
- Conditions
- Asthma
- Being tested
- Xolair®
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xolair®Drug
Also called Omalizumab
This being an observational study, the study protocol does not specify any dose regimen.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant Women Exposed to Xolair® | Women who are exposed to at least one dose of Xolair® within 8 weeks prior to conception or at any time during their pregnancy will be followed to completion of their pregnancies. Receives: Drug: Xolair® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Live Births
Measured: At Delivery (up to approximately 9 months after enrollment)
Number of Elective Terminations
Measured: At Delivery (up to approximately 9 months after enrollment)
Number of Fetal Deaths or Stillbirths
Measured: At Delivery (up to approximately 9 months after enrollment)
Number of Congenital Birth Anomalies
Measured: At Delivery (up to approximately 9 months after enrollment)
Secondary outcomes (10)
Number of Spontaneous Abortions
Measured: At Delivery (up to approximately 9 months after enrollment)
Number of Pregnancy Complications or Abnormalities
Measured: Up to approximately 9 months after enrollment
Number of Delivery Complications or Abnormalities
Measured: At Delivery (up to approximately 9 months after enrollment)
Gestational Age of Neonates/Infants
Measured: Up to approximately 9 months after enrollment
Apgar Score of Neonates/Infants
Measured: Delivery (up to approximately 9 months after enrollment) to 18 months
Number of Infant Illnesses or Infections
Measured: Delivery (up to approximately 9 months after enrollment) to 18 months
Neonatal Platelet Count
Measured: Delivery (up to approximately 9 months after enrollment) to 18 months
Weight of Neonates/Infants
Measured: At Delivery (up to approximately 9 months after enrollment)
Length of Neonates/Infants
Measured: At Delivery (up to approximately 9 months after enrollment)
Head Circumference of Neonates/Infants
Measured: At Delivery (up to approximately 9 months after enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2006 (estimated)
- Study start20 Oct 2006
- Primary completion11 Dec 2017
- Study completion5 Jan 2018
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 309 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novartis
- Responsible party
- Sponsor
- Investigators
- Clinical Trials Hoffmann-La Roche, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00373061
- Sponsor's protocol ID
- Q2952g
- Acronym
- EXPECT
- Status last verified
- Feb 2018
- First submitted
- 5 Sep 2006
- Last updated
- 14 Feb 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Xolair® Pregnancy Registry: An Observational Study of the Use and Safety of Xolair® (Omalizumab) During Pregnancy
- ClinicalTrials.gov ID
- NCT00373061
- Acronym / sponsor ID
- EXPECT / Q2952g
- Conditions
- Asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 309 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Novartis
- Study start
- 20 Oct 2006 (actual)
- Primary completion
- 11 Dec 2017 (actual)
- Study completion
- 5 Jan 2018 (actual)
- First posted
- 7 Sep 2006 (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.
The Xolair® Pregnancy Registry is an observational study established by Genentech to obtain data on pregnancy outcomes in women who are exposed to Xolair®. Women exposed to at least one dose of Xolair® within 8 weeks prior to conception or at any time during their pregnancy will be followed to completion of their pregnancies. The evaluation of infants will be conducted at birth and at 6-month intervals until the infants are 12 months old. Follow-up of the infant will be extended until the infant is 18 months old, if the woman continues Xolair® treatment while breastfeeding.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant Women Exposed to Xolair® | – | Drug: Xolair®Women who are exposed to at least one dose of Xolair® within 8 weeks prior to conception or at any time during their pregnancy will be followed to completion of their pregnancies. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Women exposed to at least one dose of Xolair® within 8 weeks prior to conception or at any time during their pregnancy. Enrollment in the Xolair® Pregnancy Registry is voluntary and must be initiated by the pregnant woman. A healthcare provider cannot enroll a patient but can suggest that the pregnant woman call the Registry Center to enroll herself.
Key inclusion criteria (1 listed)
- Women who have been exposed to at least one dose of Xolair® (whether inadvertent or deliberate) within 8 weeks prior to conception or during pregnancy
Key exclusion criteria (3 listed)
- Women not currently pregnant
- Women exposed to Xolair® not during pregnancy but only while breastfeeding
- Re-enrollment of women who are pregnant for second (or more) time is not allowed
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®Also: OmalizumabThis being an observational study, the study protocol does not specify any dose regimen. | Drug | Pregnant Women Exposed to Xolair® |
Primary outcome
Number of Live Births
Time frame: At Delivery (up to approximately 9 months after enrollment)
Number of Elective Terminations
Time frame: At Delivery (up to approximately 9 months after enrollment)
Number of Fetal Deaths or Stillbirths
Time frame: At Delivery (up to approximately 9 months after enrollment)
Number of Congenital Birth Anomalies
Time frame: At Delivery (up to approximately 9 months after enrollment)
10 secondary outcomes
Number of Spontaneous Abortions
Time frame: At Delivery (up to approximately 9 months after enrollment)
Number of Pregnancy Complications or Abnormalities
Time frame: Up to approximately 9 months after enrollment
Number of Delivery Complications or Abnormalities
Time frame: At Delivery (up to approximately 9 months after enrollment)
Gestational Age of Neonates/Infants
Time frame: Up to approximately 9 months after enrollment
Apgar Score of Neonates/Infants
Time frame: Delivery (up to approximately 9 months after enrollment) to 18 months
Number of Infant Illnesses or Infections
Time frame: Delivery (up to approximately 9 months after enrollment) to 18 months
Neonatal Platelet Count
Time frame: Delivery (up to approximately 9 months after enrollment) to 18 months
Weight of Neonates/Infants
Time frame: At Delivery (up to approximately 9 months after enrollment)
Length of Neonates/Infants
Time frame: At Delivery (up to approximately 9 months after enrollment)
Head Circumference of Neonates/Infants
Time frame: At Delivery (up to approximately 9 months after enrollment)
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 14 Feb 2018.
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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.
Clinical Trials Hoffmann-La Roche study director
Hoffmann-La Roche
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by Genentech, Inc. at 1 site in United States.
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 1 inclusion and 3 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 14 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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.
What does the primary outcome measure?
Number of Live Births (time frame: At Delivery (up to approximately 9 months after enrollment)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 14 Feb 2018.