A Global Imatinib and Nilotinib Pregnancy Exposure Registry

Novartis Pharmaceuticals4 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

All Indications for Glivec/Gleevec and Tasigna

Interventions

TasignaDRUG

GleevecDRUG

Eligibility

Sex: FEMALE

Medical Language ↔ Plain English

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 (1)

INC Research, LLC

Wilmington, North Carolina, United States

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

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

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

Time frame: 12 months after birth

Data from ClinicalTrials.gov

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