← Back to Search

Anticoagulant

Apixaban for Blood Clots in Children

Q: Do you have to be a certain age to participate in this research?

The age requirements to enroll in this particular trial are 0 days to 17 years old. Out of the 127 clinical trials being conducted, only 7 are for individuals younger than 18.

Q: Are there other experimental drugs similar to Apixaban?

<a href="https://www.withpower.com/clinical-trials/apixaban">Apixaban</a> was first tested in 2015 at the Shrewsbury &#x26; Telford Hospital National Health Service. There have been 348 completed clinical trials to date, with 50 more ongoing. A notable amount of these studies are based in Palo Alto, <a href="https://www.withpower.com/clinical-trials/california">California</a>.

Q: Have other treatments been trialed like this one before?

Research for <a href="https://www.withpower.com/clinical-trials/apixaban">Apixaban</a> began in 2015 with a study sponsored by the pharmaceutical company, Pfizer. The first trial had 4012 participants and, after being approved in Phase 4, there are now 50 active studies involving Apixaban being conducted in 380 cities across 35 countries.

Q: Does Apixaban have a good safety profile for patients?

Since <a href="https://www.withpower.com/clinical-trials/apixaban">Apixaban</a> has been approved, it is classified as a Phase 4 trial and received a score of 3 for safety.

Q: What are some of the more popular reasons that patients take Apixaban?

While <a href="https://www.withpower.com/clinical-trials/atrial-fibrillation">atrial fibrillation</a> is the primary reason <a href="https://www.withpower.com/clinical-trials/apixaban">Apixaban</a> is prescribed, it can also be an effective treatment for deep vein thrombosis, disease, and cerebrovascular accident.

Q: Are there any more vacancies in this clinical trial for new volunteers?

That is accurate. The clinicaltrials.gov website has information suggesting that this trial is looking for more participants. This trial was first posted on November 22nd, 2015 and was last edited on October 4th, 2022. The study needs around 250 individuals to fill the positions at 70 different locations.

Q: To what extent do the inclusion criteria limit subject recruitment for this research?

This trial is recruiting 250 patients, between the ages of 0 Days and 17 who have venous thromboembolism. It is required that participants also meet the following criteria: Birth to &#x3C;18 years of age with a minimum weight of 2.6 kg at the time of randomization., Presence of an index VTE which is confirmed by imaging., Intention to manage the index VTE with anticoagulation treatment for at least 6 to 12 weeks., Subjects able to tolerate oral feeding, nasogastric (NG), gastric (G) feeding and are currently tolerating enteric medications, as per investigator

Phase 4

Recruiting

Research Sponsored by Bristol-Myers Squibb

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Birth to <18 years of age with a minimum weight of 2.6 kg at the time of randomization

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 14

Awards & highlights

Study Summary

This trial looks at whether the drug apixaban is safe and effective for children with a blood clotting disorder.

Who is the study for?

This trial is for children from birth to under 18 years old, weighing at least 2.6 kg, who have a blood clot confirmed by imaging and can take oral or tube-fed medication. It's not for kids treated for clots over 14 days prior, with certain medical conditions like uncontrolled high blood pressure, liver issues, bleeding risks, severe kidney problems or on life-saving therapies.Check my eligibility

What is being tested?

The study tests the safety and effectiveness of apixaban compared to standard care in treating young patients with venous thromboembolism (VTE). Apixaban is an oral anticoagulant that could potentially be used instead of traditional treatments.See study design

What are the potential side effects?

Apixaban may cause bleeding complications which can range from minor bruising to serious bleeding events. Other side effects might include allergic reactions, liver enzyme changes, and possibly others as it's being studied in children.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am under 18 years old and weigh at least 2.6 kg.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 14

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 14

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 14 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

A composite of all image confirmed and adjudicated symptomatic and asymptomatic recurrent VTE and VTE related mortality.

The composite of major and clinically relevant non major bleeding.

Secondary outcome measures

Anti-Xa Levels

Apixaban concentration

Side effects data

From 2018 Phase 4 trial • 557 Patients • NCT01884337

Incision site pain

100%

80%

60%

40%

20%

Study treatment Arm

TOTAL KNEE REPLACEMENT (TKR)

TOTAL HIP REPLACEMENT (THR)

Trial Design

1Treatment groups

Experimental Treatment

Group I: ApixabanExperimental Treatment2 Interventions

Subjects between birth to <18 years will be dosed on a body weight tiered regimen. Subjects ≥35kg will receive 10mg twice daily(BID) for 7 days followed by 5mg BID thereafter;<35kg to 25kg will receive 8mg BID for 7 days followed by 4mg BID thereafter;<25 to 18kg will receive 6mg BID for 7 days and then 3mg BID thereafter;<18 to 12kg will receive 4mg BID for 7 days and then 2mg BID thereafter;<12 to 9kg will receive 3mg BID for 7 days and then 1.5mg BID thereafter;< 9kg to 6kg will receive 2 mg BID for 7 days and 1mg BID thereafter;<6kg to 5kg will receive 1mg BID for 7 days and 0.5mg BID thereafter;<5kg to 4kg will receive 0.6mg twice daily for 7 days and 0.3mg BID thereafter;PK cohort neonates ≥ 2.6kg will receive 0.1mg BID. Dose will be adjusted as determined by PK measurements (ie, to 0.2mg BID, 0.1mg daily or dose will stay the same).For the post PK cohort Neonates ˂4kg to 2.6kg, if confirmed by PK sub analysis,subjects will receive 0.2mg BID for 7 days and 0.1mg BID thereafter.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Standard of Care

2017

Completed Phase 4

~4420

Apixaban

2011

Completed Phase 4

~132290

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

PfizerIndustry Sponsor

4,570 Previous Clinical Trials

10,910,735 Total Patients Enrolled

9 Trials studying Deep Vein Thrombosis

1,022,495 Patients Enrolled for Deep Vein Thrombosis

Bristol-Myers SquibbLead Sponsor

2,639 Previous Clinical Trials

4,128,782 Total Patients Enrolled

9 Trials studying Deep Vein Thrombosis

22,997 Patients Enrolled for Deep Vein Thrombosis

Pfizer CT.gov Call CenterStudy DirectorPfizer

3,476 Previous Clinical Trials

8,091,931 Total Patients Enrolled

4 Trials studying Deep Vein Thrombosis

88 Patients Enrolled for Deep Vein Thrombosis

Media Library

Apixaban (Anticoagulant) Clinical Trial Eligibility Overview. Trial Name: NCT02464969 — Phase 4

Deep Vein Thrombosis Research Study Groups: Apixaban

Deep Vein Thrombosis Clinical Trial 2023: Apixaban Highlights & Side Effects. Trial Name: NCT02464969 — Phase 4

Apixaban (Anticoagulant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02464969 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do you have to be a certain age to participate in this research?

"The age requirements to enroll in this particular trial are 0 days to 17 years old. Out of the 127 clinical trials being conducted, only 7 are for individuals younger than 18."

Answered by AI

Are there other experimental drugs similar to Apixaban?

"Apixaban was first tested in 2015 at the Shrewsbury & Telford Hospital National Health Service. There have been 348 completed clinical trials to date, with 50 more ongoing. A notable amount of these studies are based in Palo Alto, California."

Answered by AI

Have other treatments been trialed like this one before?

"Research for Apixaban began in 2015 with a study sponsored by the pharmaceutical company, Pfizer. The first trial had 4012 participants and, after being approved in Phase 4, there are now 50 active studies involving Apixaban being conducted in 380 cities across 35 countries."

Answered by AI

Does Apixaban have a good safety profile for patients?

"Since Apixaban has been approved, it is classified as a Phase 4 trial and received a score of 3 for safety."

Answered by AI

What are some of the more popular reasons that patients take Apixaban?

"While atrial fibrillation is the primary reason Apixaban is prescribed, it can also be an effective treatment for deep vein thrombosis, disease, and cerebrovascular accident."

Answered by AI

Are there any more vacancies in this clinical trial for new volunteers?

"That is accurate. The clinicaltrials.gov website has information suggesting that this trial is looking for more participants. This trial was first posted on November 22nd, 2015 and was last edited on October 4th, 2022. The study needs around 250 individuals to fill the positions at 70 different locations."

Answered by AI

To what extent do the inclusion criteria limit subject recruitment for this research?

"This trial is recruiting 250 patients, between the ages of 0 Days and 17 who have venous thromboembolism. It is required that participants also meet the following criteria: Birth to <18 years of age with a minimum weight of 2.6 kg at the time of randomization., Presence of an index VTE which is confirmed by imaging., Intention to manage the index VTE with anticoagulation treatment for at least 6 to 12 weeks., Subjects able to tolerate oral feeding, nasogastric (NG), gastric (G) feeding and are currently tolerating enteric medications, as per investigator"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Apixaban for the Acute Treatment of Venous Thromboembolism in Children

2015. "Apixaban for the Acute Treatment of Venous Thromboembolism in Children". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02464969.

All > Oklahoma > Paid Studies Delaware