Venous ThromboembolismPhase 1NCT01195727
Multiple-Dose Study Apixaban in Pediatric Subjects With an Indwelling Central Venous Catheter
A Phase 1 study testing Apixaban in people with Venous Thromboembolism, run by Bristol-Myers Squibb at 14 sites in 5 countries.
Trial summary
CV185-079 is a multiple dose Apixaban Pharmacokinetics/Pharmacodynamics (PK/PD) study in pediatric subjects. The objective of this study is primarily to study the PK/PD of Apixaban in pediatric subjects with a central venous catheter. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Venous Thromboembolism
- What is being tested?
- Apixaban
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 14 sitesin 5 countries
- Study dates
- 26 Jul 2011to 16 Jul 2012
- Phase
- Phase 1
- 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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subjects with chronic stable disease with any type of functioning CVC in the upper or lower venous system (e.g., jugular, subclavian; femoral vein) that is anticipated to remain in the subject for the treatment portion of the study.
- > 12 to <18 years of age
Who cannot join
- Current or recent (within 3 months of study drug administration) gastrointestinal disease or gastrointestinal surgery that, in the opinion of the investigator and the BMS Medical Monitor, could impact the absorption of the study drug
- Active bleeding or high risk of bleeding
Trial locations and contacts
14 sites in 5 countries.
14 sites in 5 countries
Mexico5 sites
Local Institution
Guadalajara, Jalisco, 44340
Local Institution
Mexico City, Mexico City, 04530
Local Institution
Mexico City, Mexico City, 14080
Local Institution
Mexico, D. F., Mexico City, 11000
Local Institution
Puebla City, Puebla, 72190
United States4 sites
Penn State Hershey Children'S Hospital
Hershey, Pennsylvania, 17033
Saint Peter'S University Hospital
New Brunswick, New Jersey, 08901
Children'S Hospital Of Orange County
Orange, California, 92868
The Toledo Children'S Hospital
Toledo, Ohio, 43606
Canada2 sites
Local Institution
Edmonton, Alberta, T6G 2B7
Local Institution
Ottawa, Ontario, K1H 8L1
About this study
Official title: Multiple-Dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Apixaban in Pediatric Subjects With an Indwelling Central Venous Catheter
CV185-079 is a multiple dose Apixaban Pharmacokinetics/Pharmacodynamics (PK/PD) study in pediatric subjects. The objective of this study is primarily to study the PK/PD of Apixaban in pediatric subjects with a central venous catheter.
- Conditions
- Venous Thromboembolism
- Being tested
- Apixaban
- Medical subject headings
- Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApixabanDrug
Also called BMS-562247
| Study group | Role | What they receive |
|---|---|---|
| Group 5A - Apixaban (Low Dose) | Experimental | Group 5: 12 years to <18 years;
0.66 mg/m² Oral solution, Oral, Twice A Day (BID), 10 days Receives: Drug: Apixaban |
| Group 5B - Apixaban (High Dose) | Experimental | Group 5: 12 years to <18 years;
1.32 mg/m² Oral solution, Oral, Twice A Day (BID), 10 days Receives: Drug: Apixaban |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic (PK): Model-derived population & individual PK parameters (e.g., CL/F, Vc/F, KA) used to estimate steady state Cmax & AUC(TAU), Cmin & Tmax in each subject. Population PK model will be developed using plasma concentration vs time data
Measured: Days 1, 2, Day 5, 6 or 7 and Day 11
Secondary outcomes (1)
Evidence of anti-Factor Xa confirmed by analysis of anti-Factor Xa PD analysis
Measured: Days 1, 2, Day 5, 6 or 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2010 (estimated)
- Study start26 Jul 2011
- Primary completion14 Jun 2012
- Study completion16 Jul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01195727
- Sponsor's protocol ID
- CV185-079
- Status last verified
- Apr 2017
- First submitted
- 3 Sep 2010
- Last updated
- 7 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jarugula P, Ajavon-Hartmann T, Obianom O, Ludwig E, Crevar C, Marchisin D, Wang Z, Chen W, He B, Mitchell LG, Rodriguez V, Lew G, Perera V, Murthy B, Merali S. Modeling and Simulation to Inform Apixaban Dosing in Pediatrics With Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma Treated With Asparaginase. Clin Pharmacol Ther. 2025 Aug;118(2):355-364. doi: 10.1002/cpt.3616. Epub 2025 Apr 29.
PubMed 40302153
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiple-Dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Apixaban in Pediatric Subjects With an Indwelling Central Venous Catheter
- ClinicalTrials.gov ID
- NCT01195727
- Acronym / sponsor ID
- CV185-079
- Conditions
- Venous Thromboembolism
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Study start
- 26 Jul 2011 (actual)
- Primary completion
- 14 Jun 2012 (actual)
- Study completion
- 16 Jul 2012 (actual)
- First posted
- 6 Sep 2010 (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.
CV185-079 is a multiple dose Apixaban Pharmacokinetics/Pharmacodynamics (PK/PD) study in pediatric subjects. The objective of this study is primarily to study the PK/PD of Apixaban in pediatric subjects with a central venous catheter.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 5A - Apixaban (Low Dose) | Experimental | Drug: ApixabanGroup 5: 12 years to <18 years; 0.66 mg/m² Oral solution, Oral, Twice A Day (BID), 10 days |
| Group 5B - Apixaban (High Dose) | Experimental | Drug: ApixabanGroup 5: 12 years to <18 years; 1.32 mg/m² Oral solution, Oral, Twice A Day (BID), 10 days |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Subjects with chronic stable disease with any type of functioning CVC in the upper or lower venous system (e.g., jugular, subclavian; femoral vein) that is anticipated to remain in the subject for the treatment portion of the study.
- > 12 to <18 years of age
Key exclusion criteria (2 listed)
- Current or recent (within 3 months of study drug administration) gastrointestinal disease or gastrointestinal surgery that, in the opinion of the investigator and the BMS Medical Monitor, could impact the absorption of the study drug
- Active bleeding or high risk of bleeding
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: BMS-562247 | Drug | Group 5A - Apixaban (Low Dose), Group 5B - Apixaban (High Dose) |
Primary outcome
Pharmacokinetic (PK): Model-derived population & individual PK parameters (e.g., CL/F, Vc/F, KA) used to estimate steady state Cmax & AUC(TAU), Cmin & Tmax in each subject. Population PK model will be developed using plasma concentration vs time data
Time frame: Days 1, 2, Day 5, 6 or 7 and Day 11
1 secondary outcome
Evidence of anti-Factor Xa confirmed by analysis of anti-Factor Xa PD analysis
Time frame: Days 1, 2, Day 5, 6 or 7
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2017.
- Derived from this study: PubMed 40302153Jarugula P, Ajavon-Hartmann T, Obianom O, Ludwig E, Crevar C, Marchisin D, Wang Z, Chen W, He B, Mitchell LG, Rodriguez V, Lew G, Perera V, Murthy B, Merali S. Modeling and Simulation to Inform Apixaban Dosing in Pediatrics With Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma Treated With Asparaginase. Clin Pharmacol Ther. 2025 Aug;118(2):355-364. doi: 10.1002/cpt.3616. Epub 2025 Apr 29.
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
14 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Apixaban in people with Venous Thromboembolism, run by Bristol-Myers Squibb at 14 sites in 5 countries.
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: stopped early, as of the sponsor's last update on 7 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Mexico, United States, Belgium, Canada, Netherlands. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
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?
Pharmacokinetic (PK): Model-derived population & individual PK parameters (e.g., CL/F, Vc/F, KA) used to estimate steady state Cmax & AUC(TAU), Cmin & Tmax in each subject. Population PK model will be developed using plasma concentration vs time data (time frame: Days 1, 2, Day 5, 6 or 7 and Day 11). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01195727, which also lists 1 linked publication.
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 7 Apr 2017.