Rivaroxaban Pharmacokinetics/Pharmacodynamics (PK/PD) Study in Pediatric Subjects

Bayer

Status and phase: Completed; Phase 1

Conditions: Pediatrics; Venous Thrombosis

Treatments: Drug: Rivaroxaban (Xarelto, BAY59-7939)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01145859

2009-017313-30 (EudraCT Number)

12892

Details and patient eligibility

About

The first study with rivaroxaban in pediatric subjects is a Phase I study, where the pharmacokinetic/pharmacodynamic (PK/PD) profile of rivaroxaban will be investigated to confirm that the exposure is comparable to adults. This study is a single dose study with multiple PK/PD measurements in pediatric subjects at the end of their Venous Thromboembolism (VTE) treatment.

Enrollment: 59 patients

Sex: All

Ages: 6 months to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pediatric subjects > 6 months and < 18 years of age at the time of administration of study drug.
• Patients who have completed treatment of VTE, but are considered to have risk for recurrence of VTE

Exclusion criteria

• Any major or clinically relevant bleeding during prior VTE treatment
• Abnormal coagulation tests within 7 days prior to study drug administration
• Severe renal impairment
• Planned invasive procedures prior to or after 24 hours of study drug administration

Trial design

59 participants in 1 patient group

Arm 1

Experimental group

Treatment:

Drug: Rivaroxaban (Xarelto, BAY59-7939)