A Global Imatinib and Nilotinib Pregnancy Exposure Registry A Post-Authorisation Safety Study (PASS)

Novartis Pharmaceuticals1 site in 1 country4 target enrollmentJanuary 2011

ConditionsAll Indications for Glivec/Gleevec and Tasigna

InterventionsTasigna Gleevec

DrugsTasigna Gleevec

Overview

Phase: Not Applicable
Intervention: Tasigna
Conditions: All Indications for Glivec/Gleevec and Tasigna
Sponsor: Novartis Pharmaceuticals
Enrollment: 4
Locations: 1
Primary Endpoint: Monitor pregnancies exposed to Imatinib or Nilotinib to estimate prevalence of birth defects
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a voluntary, international, primarily prospective, observational, exposure-registry and follow-up study of women receiving Imatinib and Nilotinib during pregnancy or within six months prior to pregnancy.

Registry

clinicaltrials.gov

Start Date

January 2011

End Date

March 2015

Last Updated

11 years ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

Novartis Pharmaceuticals

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Provide sufficient evidence to confirm that exposure occurred during pregnancy or within 6 months prior to exposure.
•Be at least 18 years of age
•Reside in a country supported by the Registry

Exclusion Criteria

•Cases that do not meet the eligibility criteria are deemed ineligible, including paternal exposures
•Other protocol-defined inclusion/exclusion criteria may apply

Arms & Interventions

Cohort 1 - Pregnancy/Fetal Exposure

Intervention: Tasigna

Cohort 1 - Pregnancy/Fetal Exposure

Intervention: Gleevec

Outcomes

Primary Outcomes

Monitor pregnancies exposed to Imatinib or Nilotinib to estimate prevalence of birth defects

Time Frame: During pregnancy or within 6 months prior to conception

Secondary Outcomes

Assess impact on maternal CML disease when treatment is interrupted(During pregnancy or within 6 months prior to conception)
Assess post 12 month post-delivery data on maternal and infant status(12 months after birth)