A RANDOMIZED, OPEN-LABEL, ACTIVE CONTROLLED, SAFETY AND DESCRIPTIVE EFFICACY STUDY IN PEDIATRIC SUBJECTS REQUIRING ANTICOAGULATION FOR THE TREATMENT OF A VENOUS THROMBOEMBOLIC EVENT

Phase 1

• Conditions: Venous Thromboembolism; MedDRA version: 21.1Level: LLTClassification code 10043565Term: Thromboembolic eventSystem Organ Class: 100000004866; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2014-002606-20-PT
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-08-29
• Last Update Posted: 10 June 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1. Children 3 months to <18 years of age with a minimum weight of 6 kg at the time of randomization. An approved protocol will be implemented prior to enrolment of each subsequent age group.

2.Presence of an index VTE which is confirmed by imaging. Index VTE include, but are not limited to, deep vein thrombosis, pulmonary embolus, cerebral sinovenous thrombosis, renal vein thrombosis, portal vein thrombosis, and splanchnic thrombosis.

3.Intention to manage the index VTE with anticoagulation treatment for at least 12 weeks or intention to manage the index VTE with anticoagulation treatment in neonates for at least 6 weeks.

4.Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study. Depending on local regulations, whenever the minor is able to give assent, the minor¿s assent must also be obtained.

5.Subjects/legally acceptable representatives who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

6. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use highly effective method of contraception throughout the study and for at least 33 days (5 half -lives plus 30 days) after the last dose of assigned treatment.

Are the trial subjects under 18? yes
Number of subjects for this age range: 150
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Anticoagulant treatment for the index VTE for greater than 7 days prior to randomization.

2. Cerebral sinovenous thrombosis (in Germany only).

3. Thrombectomy, thrombolytic therapy, or insertion of a caval filter to treat the index VTE

4. A mechanical heart valve

5.Active bleeding or high risk of bleeding (e.g. central nervous system (CNS) tumors) at the time of randomization.

6.Intracranial bleed, including intraventricular hemorrhage, within 3 months prior to randomization.

7.Abnormal baseline liver function (ALT > 3 x upper limit of normal (ULN) or conjugated bilirubin > 2x ULN) at randomization.

8.At the time of randomization, inadequate renal function as defined in Section 7.2.2 Estimated Glomerular Filtration Rate Assessment of the protocol.

9.Platelet count < 50×109 per L at randomization.

10.At the time of randomization, uncontrolled severe hypertension as defined in Section 7.1 Physical Examination of the protocol.

11.At the time of randomization, use of prohibited concomitant medication as listed for apixaban in Section 5.5 Concomitant Medication of the protocol.

12.Known allergy to apixaban.

13.Female subjects who are either pregnant or breastfeeding a child.

14.Geographically unavailable for follow-up.

15.Family members who are either investigational site staff members directly involved in the conduct of this trial or site staff members otherwise supervised by the Investigator. Family members who are Pfizer or Bristol Myers Squibb (BMS) employees directly involved in the conduct of this trial.

16.Taking an investigational drug in other studies within 30 days before the first dose of apixaban and/or during study participation. N.B. using marketed medications commonly used in usual and customary practice, though not labeled for use in children, is acceptable.

17.Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified