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A Global Imatinib and Nilotinib Pregnancy Exposure Registry

Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: All Indications for Glivec/Gleevec and Tasigna

Intervention: Tasigna (Drug); Gleevec (Drug)

Phase: N/A

Status: Completed

Sponsored by: Novartis Pharmaceuticals

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals

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.

Clinical Details

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

Study design: Observational Model: Cohort, Time Perspective: Prospective

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

Secondary outcome:

Assess impact on maternal CML disease when treatment is interrupted

Assess post 12 month post-delivery data on maternal and infant status

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Female.

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

Locations and Contacts

INC Research, LLC, Wilmington, North Carolina 28405, United States
Additional Information

Starting date: January 2011
Last updated: April 14, 2015

Page last updated: August 23, 2015

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