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Clinical Trials/NCT01289054
NCT01289054CompletedNot Applicable

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

Novartis Pharmaceuticals1 site in 1 country4 target enrollmentStarted: January 2011Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
4
Locations
1
Primary Endpoint
Monitor pregnancies exposed to Imatinib or Nilotinib to estimate prevalence of birth defects
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study 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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Sex
Female
Accepts Healthy Volunteers
No

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 (Drug)

Cohort 1 - Pregnancy/Fetal Exposure

Intervention: Gleevec (Drug)

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)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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A Global Imatinib and Nilotinib Pregnancy... | Clinical Trial