All Indications for Glivec/Gleevec and TasignaNCT01289054
A Global Imatinib and Nilotinib Pregnancy Exposure Registry
An observational study of All Indications for Glivec/Gleevec and Tasigna, run by Novartis Pharmaceuticals at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- All Indications for Glivec/Gleevec and Tasigna
- What is being tested?
- Tasigna and Gleevec
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Mar 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Women exposed to any dose of Gleevec/Glivec or Tasigna during pregnancy or within 6 months prior to conception
Who may be able to join
- 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
Who cannot join
- Cases that do not meet the eligibility criteria are deemed ineligible, including paternal exposures
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Global Imatinib and Nilotinib Pregnancy Exposure Registry A Post-Authorisation Safety Study (PASS)
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.
- Being tested
- Tasigna, Gleevec
- Keywords
- Female, Pregnancy, Hematologic Pregnancy, Complications, Registry, Pregnant Registry, CML, GIST, Gleevec, Tasigna, Glivec, Pregnancy Exposure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TasignaDrug
GleevecDrug
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 - Pregnancy/Fetal Exposure | Not described Receives: Drug: Tasigna; Drug: Gleevec | |
| Cohort 2 - Interrupted TKI | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Monitor pregnancies exposed to Imatinib or Nilotinib to estimate prevalence of birth defects
Measured: During pregnancy or within 6 months prior to conception
Secondary outcomes (2)
Assess impact on maternal CML disease when treatment is interrupted
Measured: During pregnancy or within 6 months prior to conception
Assess post 12 month post-delivery data on maternal and infant status
Measured: 12 months after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2011 (estimated)
- Study startJan 2011
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for All Indications for Glivec/Gleevec and TasignaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01289054
- Sponsor's protocol ID
- CSTI571A2403
- Status last verified
- Apr 2015
- First submitted
- 31 Jan 2011
- Last updated
- 15 Apr 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Global Imatinib and Nilotinib Pregnancy Exposure Registry A Post-Authorisation Safety Study (PASS)
- ClinicalTrials.gov ID
- NCT01289054
- Acronym / sponsor ID
- CSTI571A2403
- Keywords
- Female, Pregnancy, Hematologic Pregnancy, Complications, Registry, Pregnant Registry, CML, GIST
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 3 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 - Pregnancy/Fetal Exposure | – | Drug: Tasigna, Drug: Gleevec |
| Cohort 2 - Interrupted TKI | – | – |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Women exposed to any dose of Gleevec/Glivec or Tasigna during pregnancy or within 6 months prior to conception
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Cases that do not meet the eligibility criteria are deemed ineligible, including paternal exposures
- Other protocol-defined inclusion/exclusion criteria may apply
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tasigna | Drug | Cohort 1 - Pregnancy/Fetal Exposure |
| Gleevec | Drug | Cohort 1 - Pregnancy/Fetal Exposure |
Primary outcome
Monitor pregnancies exposed to Imatinib or Nilotinib to estimate prevalence of birth defects
Time frame: During pregnancy or within 6 months prior to conception
2 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of All Indications for Glivec/Gleevec and Tasigna, run by Novartis Pharmaceuticals at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Monitor pregnancies exposed to Imatinib or Nilotinib to estimate prevalence of birth defects (time frame: During pregnancy or within 6 months prior to conception). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2015.