A Global Imatinib and Nilotinib Pregnancy Exposure Registry

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01289054
First received: January 31, 2011
Last updated: May 30, 2014
Last verified: May 2014
  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:

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 ]

Estimated Enrollment: 150
Study Start Date: January 2011
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (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

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

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
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

Contacts
Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals

Locations
United States, North Carolina
INC Research, LLC Recruiting
Wilmington, North Carolina, United States, 28405
Contact    910-679-1573      
Principal Investigator: Vikki Brown         
Denmark
Novartis Investigative Site Withdrawn
Copenhagen, Denmark, DK-2100
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

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: May 30, 2014
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:
GIST
Tasigna
Female
Pregnancy
Hematologic Pregnancy
Complications
Registry
Pregnant Registry
CML
Gleevec
Glivec
Pregnancy Exposure

ClinicalTrials.gov processed this record on October 19, 2014