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Study to Evaluate a Single Dose of Apixaban in Pediatric Subjects at Risk for a Thrombotic Disorder

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ClinicalTrials.gov Identifier: NCT01707394
Recruitment Status : Recruiting
First Posted : October 16, 2012
Last Update Posted : December 12, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
CV185118 is a single dose Apixaban PK/PD study in pediatric subjects. The objective of this study is primarily to study the PK/PD of Apixaban in pediatric subjects at risk for thrombosis

Condition or disease Intervention/treatment Phase
Thromboembolism Drug: Apixaban Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : January 10, 2013
Estimated Primary Completion Date : January 29, 2018
Estimated Study Completion Date : January 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Clots
Drug Information available for: Apixaban
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Group 1: Apixaban (low dose)

Apixaban solution by mouth or by nasogastric tube (NG) or gastronomy tube (G-tube) using a dosing syringe on the morning of Day 1

  • Group 1: Neonates to < 27 days of age
Drug: Apixaban
Other Name: BMS-562247
Experimental: Group 2A: Apixaban (low dose)

Apixaban solution 2.43 mg/ m2 by mouth or by nasogastric tube (NG) or gastronomy tube (G-tube) using a dosing syringe on the morning of Day 1

  • Group 2A: 9 months to < 2 years
Drug: Apixaban
Other Name: BMS-562247
Experimental: Group 2B: Apixaban (low dose)

Apixaban solution 1.08 mg/ m2 by mouth or by nasogastric tube (NG) or gastronomy tube (G-tube) using a dosing syringe on the morning of Day 1

  • Group 2B: 28 days to < 9 months
Drug: Apixaban
Other Name: BMS-562247
Experimental: Group 3: Apixaban (low dose)

Apixaban solution 1.17 mg/ m2 by mouth or by nasogastric tube (NG) or gastronomy tube (G-tube) using a dosing syringe on the morning of Day 1

  • Group 3: 2 years to < 6 years
Drug: Apixaban
Other Name: BMS-562247
Experimental: Group 4: Apixaban (low dose)

Apixaban solution 1.80 mg/ m2 by mouth or by nasogastric tube (NG) or gastronomy tube (G-tube) using a dosing syringe on the morning of Day 1

  • Group 4: 6 years to <12 years
Drug: Apixaban
Other Name: BMS-562247
Experimental: Group 5: Apixaban (low dose)

Apixaban solution 2.19 mg/ m2 by mouth or by nasogastric tube (NG) or gastronomy tube (G-tube) using a dosing syringe on the morning of Day 1

  • Group 5: 12 years to <18 years
Drug: Apixaban
Other Name: BMS-562247
Experimental: Group 2AA: Apixaban (low dose)

Apixaban solution 1.08 mg/ m2 by mouth or by nasogastric tube (NG) or gastronomy tube (G-tube) using a dosing syringe on the morning of Day 1

  • Group 2A: 9 months to < 2 years
Drug: Apixaban
Other Name: BMS-562247


Outcome Measures

Primary Outcome Measures :
  1. 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) ]
  2. Maximum estimated plasma concentration (Cmax) of Apixaban [ Time Frame: Up to 26 hours, post dose (from Day 1 to Day 2) ]
  3. 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) ]

Secondary Outcome Measures :
  1. Safety is measured by adverse event reports and the results of vital sign measurements, electrocardiograms, physical examinations, and clinical laboratory tests [ Time Frame: Up to 30 Days after last dosing ]
    Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing

  2. Pharmacodynamics will be measured by anti-Factor Xa confirmed by analysis of anti-Factor Xa [ Time Frame: Up to 26 hours, post dose (from Day 1 to Day 2) ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   37 Weeks to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Subjects with any stable disease that are at risk for a venous or arterial thrombotic disorder
  • Neonates (≥ 34 weeks gestation at birth or ≥ 37 weeks post conceptual age) to < 18 years of age
  • Subjects with any functional CVAD (Central Venous Access Device) in the upper or lower venous system

Exclusion Criteria:

  • 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])
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01707394


Contacts
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT# and Site #.

  Show 25 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Pfizer
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01707394     History of Changes
Other Study ID Numbers: CV185-118
2012-001581-15 ( EudraCT Number )
First Posted: October 16, 2012    Key Record Dates
Last Update Posted: December 12, 2017
Last Verified: December 2017

Additional relevant MeSH terms:
Thromboembolism
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Apixaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants