A Study of Experimental Apixaban for Venous Thromboembolism (deep vein blood clot) in Children

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Age: Up to 17 years old
Gender:
Any
Healthy Volunteers: No
Keywords: venous thromboembolism
Type: Drug study, Phase 4
Target:
3 Participants
Investigator:
Description
This research study will test the safety and effectiveness of the experimental medicine apixaban. Experimental apizaban is a new anti-clotting drug. It will be used in the treatment of these blood clots in children.

Children in this study may receive either standard treatment or apixaban.

Children who receive standard treatment may receive drugs currently used by doctors to treat blood clots. These drugs include:
- vitamin K antagonists (drugs that keep the body from making proteins used in making blood clots)
- low molecular weight heparins and unfractionated heparin (which prevent the body from making blood clots)

The use of apixaban in this study is experimental because apixaban is not currently approved by the FDA to treat blood clots in children. However, it is approved to treat blood clots in adults.
This study requires

The study team will make sure you qualify to take part in the study. Qualified participants will receive detailed information about the study. This may include a list of study-related tests and procedures.

Who can participate

Inclusion criteria:

  1. 3 months to <18 years of age with a minimum weight of 6 kg at the time of randomization.
  2. Presence of an index VTE which is confirmed by imaging.
  3. Intention to manage the index VTE with anticoagulation treatment for at least 12 weeks.

Exclusion criteria:

  1. Anticoagulant treatment for the index VTE for greater than 7 days prior to randomization.
  2. Thrombectomy, thrombolytic therapy, or insertion of a caval filter to treat the index VTE.
  3. A mechanical heart valve.
  4. Active bleeding or high risk of bleeding at the time of randomization.
  5. Intracranial bleed, including intraventricular hemorrhage, within 3 months prior to randomization.
  6. Abnormal baseline liver function at randomization.
  7. Inadequate renal function at the time of randomization.
  8. Platelet count <50×109 per L at randomization.
  9. Uncontrolled severe hypertension at the time of randomization.
  10. Use of prohibited concomitant medication at the time of randomization.
  11. Female subjects who are either pregnant or breastfeeding a child.
Benefits and risks of participating
BENEFITS:

We cannot promise any benefits to you as a result of taking part in this research study.


RISKS:

The study doctor will discuss the risks associated with taking part in this research study.
Compensation
You will not be compensated for taking part in this study. However, you will be reimbursed $30 for each visit you complete to cover your travel-related expenses. You will be paid by check (please note that payment can take up to six or eight weeks).
Resources
Schedule
Study duration and period
You will be in this study for about 17 weeks. You will need to visit the research site at least 5 times during the study. Depending on the judgement of your study doctor, you may be in the study for up to 12 additional weeks.
Recruitment period
From Dec. 14, 2018
Location
UC Davis Medical Center
2315 Stockton Boulevard
Sacramento, CA 95817
Contact
Elizabeth Guy
Research Topic
Conditions:
  • Venous Thromboembolism