A Global Imatinib and Nilotinib Pregnancy Exposure Registry

April 14, 2015 updated by: Novartis Pharmaceuticals

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Wilmington, North Carolina, United States, 28405
        • INC Research, LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women exposed to any dose of Gleevec/Glivec or Tasigna during pregnancy or within 6 months prior to conception

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cohort 1 - Pregnancy/Fetal Exposure
Drug: Gleevec
Drug: Tasigna
Cohort 2 - Interrupted TKI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Monitor pregnancies exposed to Imatinib or Nilotinib to estimate prevalence of birth defects
Time Frame: During pregnancy or within 6 months prior to conception
During pregnancy or within 6 months prior to conception

Secondary Outcome Measures

Outcome Measure
Time Frame
Assess impact on maternal CML disease when treatment is interrupted
Time Frame: During pregnancy or within 6 months prior to conception
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
12 months after birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

January 31, 2011

First Submitted That Met QC Criteria

February 2, 2011

First Posted (Estimate)

February 3, 2011

Study Record Updates

Last Update Posted (Estimate)

April 15, 2015

Last Update Submitted That Met QC Criteria

April 14, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSTI571A2403

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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