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

Venous Thrombosis Clinical Trial

Official title:

Single-dose Pilot Study of Oral Rivaroxaban in Pediatric Subjects With Venous Thromboembolism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01145859
• Other study ID #: 12892
• Secondary ID: 2009-017313-30
• Status: Completed
• Phase: Phase 1
• First received: June 16, 2010
• Last updated: August 5, 2015
• Start date: November 2010
• Est. completion date: July 2015

Study information

• Verified date: August 2015
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics CommissionGermany: Federal Institute for Drugs and Medical DevicesAustralia: Department of Health and Ageing Therapeutic Goods AdministrationAustria: EthikkommissionAustria: Federal Office for Safety in Health CareCanada: Ethics Review CommitteeCanada: Health CanadaIsrael: Ethics CommissionIsrael: Ministry of HealthItaly: Ethics CommitteeItaly: National Institute of HealthUnited States: Food and Drug AdministrationUnited States: Institutional Review BoardFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 18 Years

Eligibility

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

Study Design

Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Pediatrics
• Thrombosis
• Venous Thrombosis

Intervention

Drug:
• Rivaroxaban (Xarelto, BAY59-7939)
Weight adjusted dose with equivalent exposure compared to 10 mg or 20 mg doses in adults

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Janssen Research & Development, LLC

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Canada,  France,  Germany,  Ireland,  Israel,  Italy,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics parameters (AUC and Cmax)		From Day 1 to Day 2	No
Primary	Pharmacodynamics parameters (PT, aPTT and anti-factor Xa)		From Day 1 to Day 2	No
Secondary	Safety and tolerability of rivaroxaban in pediatric subjects		Day 1, day 2 plus 7 days follow up	Yes

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