A Global Imatinib and Nilotinib Pregnancy Exposure Registry | NCT01289054

Studies
A Global Imatinib and Nilotinib Pregnancy Exposure Registry

NCT01289054

Sponsor

Novartis Pharmaceuticals

Status

Completed

Last Update Posted

Apr 15, 2015Estimated

Enrollment

4Actual

Phase

Not provided

Conditions

All Indications for Glivec/Gleevec and Tasigna

Interventions

Tasigna
Gleevec

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2011

Primary Completion Date

Mar 2015Actual

Completion Date

Mar 2015Actual

First Submitted Date

Jan 31, 2011

First Submission Date that Met QC Criteria

Feb 2, 2011

First Posted Date

Feb 3, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 14, 2015

Last Update Posted Date

Apr 15, 2015Estimated

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

4Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cohort 1 - Pregnancy/Fetal Exposure			Drug: Tasigna Drug: Gleevec
Cohort 2 - Interrupted TKI

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tasigna	Drug		Cohort 1 - Pregnancy/Fetal Exposure
Gleevec

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Monitor pregnancies exposed to Imatinib or Nilotinib to estimate prevalence of birth defects		During pregnancy or within 6 months prior to conception

Secondary Outcomes

Measure	Description	Time Frame
Assess impact on maternal CML disease when treatment is interrupted		During pregnancy or within 6 months prior to conception
Assess post 12 month post-delivery data on maternal and infant status		12 months after birth

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Women exposed to any dose of Gleevec/Glivec or Tasigna during pregnancy or within 6 months prior to conception

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
INC Research, LLC		Wilmington	North Carolina	28405	United States

Intervention Browse Module

MeSH Terms

ID	Term
C498826	nilotinib
D000068877	Imatinib Mesylate

Ancestor Terms

ID	Term
D001549	Benzamides
D000577	Amides
D009930	Organic Chemicals
D001565	Benzoates
D000146

Browse Leaves

Not provided

Browse Branches

Not provided