ThromboembolismPhase 1NCT01707394
Study to Evaluate a Single Dose of Apixaban in Pediatric Participants at Risk for a Thrombotic Disorder
A Phase 1 study testing Apixaban in people with Thromboembolism, run by Bristol-Myers Squibb at 27 sites in 5 countries.
Trial summary
CV185118 is a single dose Apixaban PK/PD study in pediatric participants. The objective of this study is primarily to study the PK/PD of Apixaban in pediatric participants at risk for thrombosis Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Thromboembolism
- What is being tested?
- Apixaban
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 27 sitesin 5 countries
- Study dates
- 10 Jan 2013to 30 Jun 2020
- 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 1 day to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Participants with any stable disease that are at risk for a venous or arterial thrombotic disorder
- Neonates ≥ 34 weeks gestational or ≥ 37 weeks post conceptual age (corrected gestational age) to <18 years of age
- Gestational and post-conceptual age will only be taken into consideration for eligibility up to 6 months of age
- Neonates: defined as newly born (within 4 weeks)
- Participants with any functional CVAD (Central Venous Access Device) in the upper or lower venous system
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
- Inability to tolerate oral medication or administration of oral medication via an enteral tube (nasogastric tube [NG tube] or gastronomy tube [G-tube])
Trial locations and contacts
27 sites in 5 countries.
27 sites in 5 countries
United States18 sites
Children's Healthcare Of Atlanta
Atlanta, Georgia, 30322
Blank Childrens Hospital
Des Moines, Iowa, 50309
Duke University Medical Center
Durham, North Carolina, 27710
Connecticut Children's Medical Center
Hartford, Connecticut, 06106
Penn State Hershey Children'S Hospital
Hershey, Pennsylvania, 17033
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
Children'S Mercy Hospital And Clinics
Kansas City, Missouri, 64108
Arkansas Children'S Hospital
Little Rock, Arkansas, 72202-3591
Kosair Charities Pediatric Clinical Research Unit
Louisville, Kentucky, 40202
Childrens Hospital Of Wisconsin
Milwaukee, Wisconsin, 53226
Saint Peter'S University Hospital
New Brunswick, New Jersey, 08901
Children'S Hospital Of Orange County
Orange, California, 92868
Childrens Hospital Of Philadelphia
Philadelphia, Pennsylvania, 19104
Children's Hopsital Of Pittsburgh Of UPMC
Pittsburgh, Pennsylvania, 15224
Children's Hospital Of Pittsburgh Of UPMC
Pittsburgh, Pennsylvania, 15224
ProMedica Toledo Children's Hospital
Toledo, Ohio, 43606
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007
Childrens National Medical Center
Washington D.C., District of Columbia, 20010
Mexico4 sites
Local Institution
Guadalajara, Jalisco, 44260
Local Institution
Mexico City, Mexico City, 04530
Local Institution
Mexico City, Mexico City, 14080
Local Institution
Monterrey, Nuevo León, 64460
Canada3 sites
University of Alberta - Edmonton Clinic Health Academy
Edmonton, Alberta, T6G 1C9
Local Institution
Hamilton, Ontario, L8S 4K1
The Hospital For Sick Children
Toronto, Ontario, M5G 1X8
About this study
Official title: Single-Dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Apixaban in Pediatric Subjects at Risk for a Venous or Arterial Thrombotic Disorder
CV185118 is a single dose Apixaban PK/PD study in pediatric participants. The objective of this study is primarily to study the PK/PD of Apixaban in pediatric participants at risk for thrombosis
- Conditions
- Thromboembolism
- Being tested
- Apixaban
- Medical subject headings
- 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
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Apixaban (low dose) | Experimental | Not described Receives: Drug: Apixaban |
| Group 2A: Apixaban (low dose) | Experimental | Not described Receives: Drug: Apixaban |
| Group 2B: Apixaban (low dose) | Experimental | Not described Receives: Drug: Apixaban |
| Group 3: Apixaban (low dose) | Experimental | Not described Receives: Drug: Apixaban |
| Group 4: Apixaban (low dose) | Experimental | Not described Receives: Drug: Apixaban |
| Group 5: Apixaban (low dose) | Experimental | Not described Receives: Drug: Apixaban |
| Group 2A (higher dose): Apixaban (low dose) | Experimental | Not described Receives: Drug: Apixaban |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimated area under the plasma concentration-time curve [AUC(INF)] of Apixaban
Measured: Up to 26 hours, post dose (from Day 1 to Day 2)
Maximum estimated plasma concentration (Cmax) of Apixaban
Measured: Up to 26 hours, post dose (from Day 1 to Day 2)
Estimated time at which maximum plasma concentration occurs (Tmax) of Apixaban
Measured: Up to 26 hours, post dose (from Day 1 to Day 2)
Secondary outcomes (14)
Number of participants with Adverse Events (AEs)
Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing
Measured: Up to 30 Days after last dosing
Number of participants with Serious Adverse Events (SAEs)
Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing
Measured: Up to 30 Days after last dosing
Change from baseline in Vital Signs of body temperature
Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing
Measured: Up to 30 Days after last dosing
Change from baseline in Vital Signs of respiratory rate
Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing
Measured: Up to 30 Days after last dosing
Change from baseline in Vital Signs of blood pressure
Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing
Measured: Up to 30 Days after last dosing
Change from baseline in Vital Signs of heart rate
Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing
Measured: Up to 30 Days after last dosing
Number of participants with abnormalities in Physical Examinations
Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing
Measured: Up to 30 Days after last dosing
Change from baseline in Clinical Laboratory Tests of blood
Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing
Measured: Up to 30 Days after last dosing
Change from baseline in Clinical Laboratory Tests of blood serum
Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing
Measured: Up to 30 Days after last dosing
Change from baseline in Activated partial thromboplastin time (aPTT) clotting activity during treatment
Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing
Measured: Up to 30 Days after last dosing
Change from baseline in International Normalized Ratio (INR) clotting activity during treatment
Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing
Measured: Up to 30 Days after last dosing
Change from baseline in Prothrombin Time (PT) clotting activity during treatment
Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing
Measured: Up to 30 Days after last dosing
Change from baseline in Clinical Laboratory Tests of urine
Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing
Measured: Up to 30 Days after last dosing
Pharmacodynamics will be analyzed using anti-Factor Xa activity
Measured: Up to 26 hours, post dose (from Day 1 to Day 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2012 (estimated)
- Study start10 Jan 2013
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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
- 49 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
- NCT01707394
- Sponsor's protocol ID
- CV185-118
- Other IDs
- 2012-001581-15
- Status last verified
- Mar 2021
- First submitted
- 12 Oct 2012
- Last updated
- 22 Mar 2021
- 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 40302153Merali SJ, Byon W, Patel YT, Elsrougy A, Marchisin D, Perera V, Chen W, He B, Murthy B. Evaluation of safety, pharmacokinetics, and pharmacodynamics of apixaban in pediatric subjects at risk of venous or arterial thrombotic disorder. CPT Pharmacometrics Syst Pharmacol. 2023 Apr;12(4):500-512. doi: 10.1002/psp4.12935. Epub 2023 Mar 5.
PubMed 36861188
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-Dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Apixaban in Pediatric Subjects at Risk for a Venous or Arterial Thrombotic Disorder
- ClinicalTrials.gov ID
- NCT01707394
- Acronym / sponsor ID
- CV185-118
- Conditions
- Thromboembolism
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Study start
- 10 Jan 2013 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 16 Oct 2012 (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.
CV185118 is a single dose Apixaban PK/PD study in pediatric participants. The objective of this study is primarily to study the PK/PD of Apixaban in pediatric participants at risk for thrombosis
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Group 1: Apixaban (low dose) | Experimental | Drug: Apixaban |
| Group 2A: Apixaban (low dose) | Experimental | Drug: Apixaban |
| Group 2B: Apixaban (low dose) | Experimental | Drug: Apixaban |
| Group 3: Apixaban (low dose) | Experimental | Drug: Apixaban |
| Group 4: Apixaban (low dose) | Experimental | Drug: Apixaban |
| Group 5: Apixaban (low dose) | Experimental | Drug: Apixaban |
| Group 2A (higher dose): Apixaban (low dose) | Experimental | Drug: Apixaban |
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Participants with any stable disease that are at risk for a venous or arterial thrombotic disorder
- Neonates ≥ 34 weeks gestational or ≥ 37 weeks post conceptual age (corrected gestational age) to <18 years of age
- Participants with any functional CVAD (Central Venous Access Device) in the upper or lower venous system
Key exclusion criteria (3 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
- Inability to tolerate oral medication or administration of oral medication via an enteral tube (nasogastric tube [NG tube] or gastronomy tube [G-tube])
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-562247Specified dose on specified days | Drug | Group 1: Apixaban (low dose), Group 2A (higher dose): Apixaban (low dose), Group 2A: Apixaban (low dose), Group 2B: Apixaban (low dose), Group 3: Apixaban (low dose), Group 4: Apixaban (low dose), Group 5: Apixaban (low dose) |
Primary outcome
Estimated area under the plasma concentration-time curve [AUC(INF)] of Apixaban
Time frame: Up to 26 hours, post dose (from Day 1 to Day 2)
Maximum estimated plasma concentration (Cmax) of Apixaban
Time frame: Up to 26 hours, post dose (from Day 1 to Day 2)
Estimated time at which maximum plasma concentration occurs (Tmax) of Apixaban
Time frame: Up to 26 hours, post dose (from Day 1 to Day 2)
14 secondary outcomes
Number of participants with Adverse Events (AEs)
Time frame: Up to 30 Days after last dosing
Number of participants with Serious Adverse Events (SAEs)
Time frame: Up to 30 Days after last dosing
Change from baseline in Vital Signs of body temperature
Time frame: Up to 30 Days after last dosing
Change from baseline in Vital Signs of respiratory rate
Time frame: Up to 30 Days after last dosing
Change from baseline in Vital Signs of blood pressure
Time frame: Up to 30 Days after last dosing
Change from baseline in Vital Signs of heart rate
Time frame: Up to 30 Days after last dosing
Number of participants with abnormalities in Physical Examinations
Time frame: Up to 30 Days after last dosing
Change from baseline in Clinical Laboratory Tests of blood
Time frame: Up to 30 Days after last dosing
Change from baseline in Clinical Laboratory Tests of blood serum
Time frame: Up to 30 Days after last dosing
Change from baseline in Activated partial thromboplastin time (aPTT) clotting activity during treatment
Time frame: Up to 30 Days after last dosing
Change from baseline in International Normalized Ratio (INR) clotting activity during treatment
Time frame: Up to 30 Days after last dosing
Change from baseline in Prothrombin Time (PT) clotting activity during treatment
Time frame: Up to 30 Days after last dosing
Change from baseline in Clinical Laboratory Tests of urine
Time frame: Up to 30 Days after last dosing
Pharmacodynamics will be analyzed using anti-Factor Xa activity
Time frame: Up to 26 hours, post dose (from Day 1 to Day 2)
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 22 Mar 2021.
- 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.
- Derived from this study: PubMed 36861188Merali SJ, Byon W, Patel YT, Elsrougy A, Marchisin D, Perera V, Chen W, He B, Murthy B. Evaluation of safety, pharmacokinetics, and pharmacodynamics of apixaban in pediatric subjects at risk of venous or arterial thrombotic disorder. CPT Pharmacometrics Syst Pharmacol. 2023 Apr;12(4):500-512. doi: 10.1002/psp4.12935. Epub 2023 Mar 5.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
Related trials for Thromboembolism
Not yet recruitingPhase 3
TicAgreLor Versus Placebo to Prevent Cerebral ISCHemia in anEuRysmal Low Grade SAH A Double Blinded Randomised Controlled Study
Subarachnoid Hemorrhage, Aneurysmal, Brain Ischemia
RecruitingPhase 3
REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults
Venous Thromboembolism (VTE)
RecruitingPhase 3
Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers
Venous Thromboembolism (VTE)
RecruitingPhase 3
REGN7508 in Adult Participants for Prevention of Cancer-Associated Thrombosis
Cancer-Associated Thrombosis (CAT)
RecruitingPhase 3
REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
Symptomatic Venous Thromboembolism (VTE)
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
27 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 Thromboembolism, run by Bristol-Myers Squibb at 27 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 5 inclusion and 3 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 22 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in United States, Mexico, Canada, Australia, Israel. 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 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?
Estimated area under the plasma concentration-time curve [AUC(INF)] of Apixaban (time frame: Up to 26 hours, post dose (from Day 1 to Day 2)). The study lists 3 primary outcomes in all. 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 NCT01707394, which also lists 2 linked publications.
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 22 Mar 2021.