NCT00373061

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
309

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 5, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 7, 2006

Completed
1 month until next milestone

Study Start

First participant enrolled

October 20, 2006

Completed
11.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 11, 2017

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 5, 2018

Completed
Last Updated

February 14, 2018

Status Verified

February 1, 2018

Enrollment Period

11.2 years

First QC Date

September 5, 2006

Last Update Submit

February 12, 2018

Conditions

Asthma

Outcome Measures

Primary Outcomes (4)

  • Number of Live Births

    At Delivery (up to approximately 9 months after enrollment)

  • Number of Elective Terminations

    At Delivery (up to approximately 9 months after enrollment)

  • Number of Fetal Deaths or Stillbirths

    At Delivery (up to approximately 9 months after enrollment)

  • Number of Congenital Birth Anomalies

    At Delivery (up to approximately 9 months after enrollment)

Secondary Outcomes (10)

  • Number of Spontaneous Abortions

    At Delivery (up to approximately 9 months after enrollment)

  • Number of Pregnancy Complications or Abnormalities

    Up to approximately 9 months after enrollment

  • Number of Delivery Complications or Abnormalities

    At Delivery (up to approximately 9 months after enrollment)

  • Gestational Age of Neonates/Infants

    Up to approximately 9 months after enrollment

  • Apgar Score of Neonates/Infants

    Delivery (up to approximately 9 months after enrollment) to 18 months

  • +5 more secondary outcomes

Study Arms (1)

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.

Drug: Xolair®

Interventions

Xolair®DRUG

This being an observational study, the study protocol does not specify any dose regimen.

Also known as: Omalizumab
Pregnant Women Exposed to Xolair®

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • \- 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ppd Development, Llc

Morrisville, North Carolina, 27560-7200, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

Omalizumab

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Anti-IdiotypicAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalSerum GlobulinsGlobulins

Study Officials

  • Clinical Trials Hoffmann-La Roche

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2006

First Posted

September 7, 2006

Study Start

October 20, 2006

Primary Completion

December 11, 2017

Study Completion

January 5, 2018

Last Updated

February 14, 2018

Record last verified: 2018-02

Locations

US(1)