Phase I Study on Rivaroxaban Granules for Oral Suspension Formulation in Children

Bayer

Status and phase: Completed; Phase 1

Conditions: Thrombosis

Treatments: Drug: Rivaroxaban (Xarelto, BAY59-7939

Study type: Interventional

Funder types: Industry

Identifiers

NCT02497716

2015-000962-76 (EudraCT Number)

17992

Details and patient eligibility

About

To characterize the pharmacokinetic profile of rivaroxaban administered as granules for suspension formulation and to document safety and tolerability

Enrollment: 47 patients

Sex: All

Ages: 2 months to 12 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Children with an age ≥2 months and weight between 3 and <12 kg, who have completed anticoagulant treatment at least 10 days prior to the planned study drug administration.

  • Gestational age at birth of at least 37 weeks
  • Oral feeding/ nasogastric/ gastric feeding for at least 10 days

• Normal PT and aPTT within 10 days prior to planned study drug administration

• Written informed consent provided and, if applicable, child assent provided

Exclusion criteria

• Active bleeding or high risk for bleeding, contraindicating anticoagulant therapy

• Planned invasive procedures, including removal of central lines, within 24 hours before and after single dose intake

• An estimate glomerular filtration rate (eGFR) < 30 mL/min/1.73m2

• Hepatic disease which is associated either with:

  • coagulopathy leading to a clinically relevant bleeding risk, or alanine aminotransferase (ALT) > 5x upper level of normal (ULN), or
  • total bilirubin > 2x ULN with direct bilirubin > 20% of the total.

• Platelet count < 50 x 10^9/L

• Hypertension (defined as systolic and/or diastolic blood pressure >95th percentile for age)

• Concomitant use of strong inhibitors of both CYP3A4 and P-glycoprotein, e.g., all human immunodeficiency virus protease inhibitors and the following azoleantimycotic agents: ketoconazole, itraconazole, voriconazole, and posaconazole, if used systemically (fluconazole is allowed)

• Concomitant use of strong inducers of CYP3A4, e.g., rifampicin, rifabutin, phenobarbital, phenytoin and carbamazepine

• Inability to cooperate with the study procedures

• Hypersensitivity to rivaroxaban

• Participation in a study with an investigational drug other than rivaroxaban or a medical device within 30 days prior to treatment

• History of gastrointestinal disease or surgery associated with impaired absorption

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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47 participants in 1 patient group

Rivaroxaban

Experimental group

Description:

Single arm, open label study

Treatment:

Drug: Rivaroxaban (Xarelto, BAY59-7939