CompletedNot Applicable

A Global Imatinib and Nilotinib Pregnancy Exposure Registry

United States4 participantsStarted 2011-01

Plain-language 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.

Who can participate

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

Timeframe: During pregnancy or within 6 months prior to conception

Trial details

NCT IDNCT01289054

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2015-03

View on ClinicalTrials.gov More All Indications for Glivec/Gleevec and Tasigna trials