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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2016 by Bristol-Myers Squibb
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01707394
First received: October 12, 2012
Last updated: September 14, 2016
Last verified: September 2016
  Purpose
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 Intervention Phase
Thromboembolism
Drug: Apixaban
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
  • Maximum estimated plasma concentration (Cmax) of Apixaban [ Time Frame: Up to 26 hours, post dose (from Day 1 to Day 2) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing

  • 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) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 44
Study Start Date: January 2013
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   37 Weeks to 18 Years   (Child, Adult)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 23 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 
Study First Received: October 12, 2012
Last Updated: September 14, 2016
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration
Canada: Health Canada
Canada: Ethics Review Committee

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

ClinicalTrials.gov processed this record on September 23, 2016