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A Global Imatinib and Nilotinib Pregnancy Exposure Registry

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01289054
First Posted: February 3, 2011
Last Update Posted: April 15, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  Purpose
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.

Condition Intervention
All Indications for Glivec/Gleevec and Tasigna Drug: Tasigna Drug: Gleevec

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Global Imatinib and Nilotinib Pregnancy Exposure Registry A Post-Authorisation Safety Study (PASS)

Resource links provided by NLM:


Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 ]

Enrollment: 4
Study Start Date: January 2011
Study Completion Date: March 2015
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Cohort 1 - Pregnancy/Fetal Exposure Drug: Tasigna Drug: Gleevec
Cohort 2 - Interrupted TKI

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01289054


Locations
United States, North Carolina
INC Research, LLC
Wilmington, North Carolina, United States, 28405
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01289054     History of Changes
Other Study ID Numbers: CSTI571A2403
First Submitted: January 31, 2011
First Posted: February 3, 2011
Last Update Posted: April 15, 2015
Last Verified: April 2015

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Female
Pregnancy
Hematologic Pregnancy
Complications
Registry
Pregnant Registry
CML
GIST
Gleevec
Tasigna
Glivec
Pregnancy Exposure

Additional relevant MeSH terms:
Imatinib Mesylate
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action