Last reviewed · How we verify

NCT00373061: EXPECT

An Observational Study of the Use and Safety of Xolair® During Pregnancy

Completed Last updated 14 February 2018
What this trial tests

trial testing Xolair® in Asthma in 309 participants. Completed in 5 January 2018.

Timeline
20 October 2006
Primary endpoint
11 December 2017
5 January 2018

Quick facts

Lead sponsorGenentech, Inc.
StatusCompleted
Study typeOBSERVATIONAL
Enrollment309
Start date20 October 2006
Primary completion11 December 2017
Estimated completion5 January 2018
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Genentech, Inc. — full company profile →

Who can join

Eligibility, female only, with Asthma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Pediatric asthma: An unmet need for more effective, focused treatments.
    Papadopoulos NG, Čustović A, Cabana MD, Dell SD, et al · · 2019 · cited 51× · PMID 30312503 · DOI 10.1111/pai.12990

Verify or expand the search:

Other recruiting trials for Asthma

Currently open trials in the same condition.

Other Genentech, Inc. trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00373061.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing