Trials / Completed
CompletedNCT00373061
An Observational Study of the Use and Safety of Xolair® During Pregnancy
The Xolair® Pregnancy Registry: An Observational Study of the Use and Safety of Xolair® (Omalizumab) During Pregnancy
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 309 (actual)
- Sponsor
- Genentech, Inc. · Industry
- Sex
- Female
- Age
- —
- Healthy volunteers
- Not accepted
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 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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Xolair® | This being an observational study, the study protocol does not specify any dose regimen. |
Timeline
- Start date
- 2006-10-20
- Primary completion
- 2017-12-11
- Completion
- 2018-01-05
- First posted
- 2006-09-07
- Last updated
- 2018-02-14
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00373061. Inclusion in this directory is not an endorsement.