Completed

NCT Number: NCT01289054

A Global Imatinib and Nilotinib Pregnancy Exposure Registry

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.

Completed

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Key information

Conditions

All Indications for Glivec/Gleevec and Tasigna

Sex eligibility

Female

Study type

Observational

Primary location

INC Research, LLC

Wilmington, North Carolina, 28405, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tasigna

Drug

Gleevec

Drug

Primary outcomes

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 outcomes

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

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start: 2011
Primary completion: 2015
Study completion: 2015
First posted: Feb 3, 2011
Registry last updated: Apr 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.