Clinical trialNCT05187286
Expanded Access for Apixaban
A study testing Apixaban, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
This is an expanded access designed to provide access to apixaban for eligible participants. Read more about this study
- Who is it for?
- Ages 28 days to 17 years
- What is being tested?
- Apixaban
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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 28 days to 17 years
- All sexes
- Child
Who may be able to join
- Pediatric patients with Congenital or Acquired Heart Disease Requiring Chronic Anticoagulation for Thromboembolism Prevention
- Previously participated in the CV185-362 study and was on apixaban for 1 year or until treatment was no longer required
Who cannot join
- Weight less than 5 kg or greater than 35 kg
- Other inclusion/exclusion criteria apply
Trial locations and contacts
1 site in 1 country.
Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, contact
First line of the email MUST contain NCT # and Site #. contact
United States1 site
- Available
Childrens Hospital Of Philadelphia
Philadelphia, Pennsylvania, 19104
Andrew Glatz, Site 0001
About this study
This is an expanded access designed to provide access to apixaban for eligible participants.
- Being tested
- Apixaban
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApixabanDrug
Also called Eliquis
Administered as directed by treating physician
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- More trials run by Bristol-Myers SquibbThe 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05187286
- Sponsor's protocol ID
- CV185-826
- Status last verified
- Mar 2022
- First submitted
- 16 Nov 2021
- Last updated
- 18 Mar 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanded Access for Apixaban
- ClinicalTrials.gov ID
- NCT05187286
- Acronym / sponsor ID
- CV185-826
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- First posted
- 11 Jan 2022 (actual)
- 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 an expanded access designed to provide access to apixaban for eligible participants.
Study design
Who may qualify
- Ages
- 28 days to 17 years
- Sex
- All
- Age groups
- Child
Key inclusion criteria (2 listed)
- Pediatric patients with Congenital or Acquired Heart Disease Requiring Chronic Anticoagulation for Thromboembolism Prevention
- Previously participated in the CV185-362 study and was on apixaban for 1 year or until treatment was no longer required
Key exclusion criteria (2 listed)
- Weight less than 5 kg or greater than 35 kg
- Other inclusion/exclusion criteria 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 |
|---|---|---|
| ApixabanAlso: EliquisAdministered as directed by treating physician | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2022.
- BMS Clinical Trial InformationLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
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.
Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, contact
First line of the email MUST contain NCT # and Site #. contact
Bristol-Myers Squibb study director
Bristol-Myers Squibb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Apixaban, run by Bristol-Myers Squibb 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 2 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: status not confirmed, as of the sponsor's last update on 18 Mar 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, (please email:, Clinical.Trials@bms.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 18 Mar 2022.