Multiple-Dose Study Apixaban in Pediatric Subjects With an Indwelling Central Venous Catheter

Bristol-Myers Squibb (BMS)

Status and phase: Terminated; Phase 1

Conditions: Venous Thromboembolism

Treatments: Drug: Apixaban

Study type: Interventional

Funder types: Industry

Identifiers

NCT01195727

CV185-079

Details and patient eligibility

About

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.

Enrollment: 13 patients

Sex: All

Ages: 12 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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13 participants in 2 patient groups

Group 5A - Apixaban (Low Dose)

Experimental group

Description:

Group 5: 12 years to \<18 years; 0.66 mg/m² Oral solution, Oral, Twice A Day (BID), 10 days

Treatment:

Drug: Apixaban

Group 5B - Apixaban (High Dose)

Experimental group

Description:

Group 5: 12 years to \<18 years; 1.32 mg/m² Oral solution, Oral, Twice A Day (BID), 10 days

Treatment:

Drug: Apixaban