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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Thromboembolism

Treatments: Drug: Apixaban

Study type: Interventional

Funder types: Industry

Identifiers

NCT01707394

2012-001581-15 (EudraCT Number)

CV185-118

Details and patient eligibility

About

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

Enrollment: 49 patients

Sex: All

Ages: 1 day to 18 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Inclusion Criteria:

• 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

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])

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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49 participants in 7 patient groups

Group 1: Apixaban (low dose)

Experimental group

Treatment:

Drug: Apixaban

Group 2A: Apixaban (low dose)

Experimental group

Treatment:

Drug: Apixaban

Group 2B: Apixaban (low dose)

Experimental group

Treatment:

Drug: Apixaban

Group 3: Apixaban (low dose)

Experimental group

Treatment:

Drug: Apixaban

Group 4: Apixaban (low dose)

Experimental group

Treatment:

Drug: Apixaban

Group 5: Apixaban (low dose)

Experimental group

Treatment:

Drug: Apixaban

Group 2A (higher dose): Apixaban (low dose)

Experimental group

Treatment:

Drug: Apixaban