A Global Imatinib and Nilotinib Pregnancy Exposure Registry

This study has been completed.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
First received: January 31, 2011
Last updated: April 14, 2015
Last verified: April 2015
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:

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Assess impact on maternal CML disease when treatment is interrupted [ Time Frame: During pregnancy or within 6 months prior to conception ] [ Designated as safety issue: Yes ]
  • Assess post 12 month post-delivery data on maternal and infant status [ Time Frame: 12 months after birth ] [ Designated as safety issue: Yes ]

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


Genders 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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01289054

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

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01289054     History of Changes
Other Study ID Numbers: CSTI571A2403 
Study First Received: January 31, 2011
Last Updated: April 14, 2015
Health Authority: United States: Food and Drug Administration
Australia: Human Research Ethics Committee
Australia: National Health and Medical Research Council
Denmark: The Danish National Committee on Biomedical Research Ethics
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Novartis:
Hematologic Pregnancy
Pregnant Registry
Pregnancy Exposure

ClinicalTrials.gov processed this record on May 01, 2016