A Global Imatinib and Nilotinib Pregnancy Exposure Registry
This study is currently recruiting participants.
Verified November 2012 by Novartis
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01289054
First received: January 31, 2011
Last updated: November 29, 2012
Last verified: November 2012
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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, 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: | April 2009 |
| Estimated Primary Completion Date: | October 2015 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| Cohort 1 - Pregnancy/Fetal Exposure |
Drug: Tasigna, Gleevec
Other Name: AMN107, STI571
|
| Cohort 2 - Interrupted TKI |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01289054
Contacts
| Contact: Novartis Pharmaceuticals | 800-340-6843 |
Locations
| United States, North Carolina | |
| Kendle, a subsidiary of INC Research, LLC | Recruiting |
| Wilmington, North Carolina, United States, 28405 | |
| Contact: Susan Goodlow 877-513-6684 | |
| Denmark | |
| Novartis Investiative Site | Recruiting |
| Copenhagen, Denmark | |
| Netherlands | |
| Novartis Investigative Site | Recruiting |
| Amsterdam, Netherlands | |
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: | November 29, 2012 |
| 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 |
Additional relevant MeSH terms:
|
Imatinib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013