Pediatric Venous ThromboembolismPhase 4NCT07618988
Rivaroxaban in Pediatric Patients With DVT
A Phase 4 study testing Rivaroxaban and Enoxaparin, Heparin in people with Pediatric Venous Thromboembolism, run by Ain Shams University at 1 site in Egypt.
Trial summary
Prospective interventional randomized controlled trial to assess safety and efficacy of rivaroxaban in pediatric patients with acute deep venous thrombosis. Read more about this study
- Who is it for?
- Ages 6 months to 18 years
- Conditions the study is for
- Pediatric Venous Thromboembolism
- What is being tested?
- Rivaroxaban and Enoxaparin, Heparin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Aug 2024to 1 May 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients from 6 months to less than 18 years of age.
- Patients with acute deep venous thrombosis diagnosed based on site-appropriate imaging tools e.g., magnetic resonance venography (MRV) in Cerebral sinus venous thrombosis (CSVT), venous duplex in Central Venous Access Devices (CVAD) related thrombosis or other non-CSVT DVT.
- Patients with cancer associated thrombosis are eligible.
- Patients with provoked or unprovoked acute VT are eligible.
- Patients with first thrombotic event or recurrent VT are eligible.
Who cannot join
- Patients with active bleeding
- High-risk of bleeding including:
- Platelet count of less than 50 x 109/L,
- Liver disease associated either a coagulopathy leading to a clinically relevant bleeding risk, or ALT > 5× ULN.
- Sustained uncontrolled hypertension defined as systolic and/or diastolic blood pressure > 95th age percentile.
- Severe renal impairment (Estimated glomerular filtration rate < 30 mL/min/1.73m2).
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- Gastrointestinal disease associated with impaired absorption.
- Hypersensitivity or any other contraindication listed in the local labelling for Rivaroxaban or comparator treatment.
- Patients with rheumatic heart disease or prosthetic heart valves.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy of Rivaroxaban in Pediatric Patients With Deep Venous Thrombosis
Prospective interventional randomized controlled trial to assess safety and efficacy of rivaroxaban in pediatric patients with acute deep venous thrombosis.
Read the detailed description
Treatment of deep venous thrombotic events in children is based on data obtained in adults with little direct documentation of its efficacy and safety in children. Rivaroxaban is a direct oral anticoagulant which has been approved by FDA in 2021 for the use in pediatric patients with venous thrombosis.
In a randomized controlled trial we will study the safety and efficacy of rivaroxaban use in the pediatric population with acute deep venous thrombosis.
- Conditions
- Pediatric Venous Thromboembolism
- Being tested
- Rivaroxaban, Enoxaparin, Heparin
- Keywords
- Children, Deep venous thrombosis, Direct oral anticoagulant, anticoagulation
- Medical subject headings
- Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RivaroxabanDrug
Patients allocated to Rivaroxaban arm: after 5 to 9 days of therapy with low molecular weight heparin (LMWH), patients will receive body weight-adjusted 20-mg equivalent doses with an age-appropriate serving of fluid given with or shortly after a meal.
Crushed Rivaroxaban tablet is stable for up to 4 hours and displays similar relative bioavailability compared to a whole tablet administered orally.
Enoxaparin, HeparinDrug
Patients in arm 1 will receive standard anticoagulation with enoxaparin sodium at a dose 1mg/kg twice daily for 3 months duration
| Study group | Role | What they receive |
|---|---|---|
| LMWH arm | Active comparator | Patients assigned to LMWH will receive standard anticoagulation with enoxaparin sodium at a dose 1mg/kg twice daily for 3 months duration. Receives: Drug: Enoxaparin, Heparin |
| Rivaroxaban | Experimental | Patients allocated to Rivaroxaban: after 5 to 9 days of therapy with low molecular weight heparin (LMWH), patients will receive body weight-adjusted 20-mg equivalent doses with an age-appropriate serving of fluid given with or shortly after a meal.
Crushed Rivaroxaban tablet is stable for up to 4 hours and displays similar relative bioavailability compared to a whole tablet administered orally. Receives: Drug: Rivaroxaban |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of vein recanalization
A Repeat site-appropriate imaging at 3 months will be done to assess the degree of vein recanalization and response will be classified as
- Normalized: if no residual thrombus is observed,
- Improved: if thrombus is still present but partly recanalized or involving less venous segments,
- Unchanged: if not recanalized and similar in extent
- Deteriorated: if new venous segment involved
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start3 Aug 2024
- Primary completion31 Dec 2025
- Study completion1 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pediatric Venous ThromboembolismStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fatma SE Ebeid, MD, Study director, Faculty of Medicine Ain Shams UniversityAmira Adly, Principal investigator, Faculty of Medicine Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07618988
- Sponsor's protocol ID
- FMASU MD 156/2024
- Status last verified
- Jan 2025
- First submitted
- 26 May 2026
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Moore KT, Krook MA, Vaidyanathan S, Sarich TC, Damaraju CV, Fields LE. Rivaroxaban crushed tablet suspension characteristics and relative bioavailability in healthy adults when administered orally or via nasogastric tube. Clin Pharmacol Drug Dev. 2014 Jul;3(4):321-7. doi: 10.1002/cpdd.123. Epub 2014 May 16.
PubMed 27128839Lensing AWA, Male C, Young G, Kubitza D, Kenet G, Patricia Massicotte M, Chan A, Molinari AC, Nowak-Goettl U, Pap AF, Adalbo I, Smith WT, Mason A, Thelen K, Berkowitz SD, Crowther M, Schmidt S, Price V, Prins MH, Monagle P. Rivaroxaban versus standard anticoagulation for acute venous thromboembolism in childhood. Design of the EINSTEIN-Jr phase III study. Thromb J. 2018 Dec 21;16:34. doi: 10.1186/s12959-018-0188-y. eCollection 2018.
PubMed 30598642Young G, Lensing AWA, Monagle P, Male C, Thelen K, Willmann S, Palumbo JS, Kumar R, Nurmeev I, Hege K, Bajolle F, Connor P, Hooimeijer HL, Torres M, Chan AKC, Kenet G, Holzhauer S, Santamaria A, Amedro P, Beyer-Westendorf J, Martinelli I, Massicotte MP, Smith WT, Berkowitz SD, Schmidt S, Price V, Prins MH, Kubitza D; EINSTEIN-Jr. Phase 3 Investigators. Rivaroxaban for treatment of pediatric venous thromboembolism. An Einstein-Jr phase 3 dose-exposure-response evaluation. J Thromb Haemost. 2020 Jul;18(7):1672-1685. doi: 10.1111/jth.14813. Epub 2020 Jun 4.
PubMed 32246743Male C, Lensing AWA, Palumbo JS, Kumar R, Nurmeev I, Hege K, Bonnet D, Connor P, Hooimeijer HL, Torres M, Chan AKC, Kenet G, Holzhauer S, Santamaria A, Amedro P, Chalmers E, Simioni P, Bhat RV, Yee DL, Lvova O, Beyer-Westendorf J, Biss TT, Martinelli I, Saracco P, Peters M, Kallay K, Gauger CA, Massicotte MP, Young G, Pap AF, Majumder M, Smith WT, Heubach JF, Berkowitz SD, Thelen K, Kubitza D, Crowther M, Prins MH, Monagle P; EINSTEIN-Jr Phase 3 Investigators. Rivaroxaban compared with standard anticoagulants for the treatment of acute venous thromboembolism in children: a randomised, controlled, phase 3 trial. Lancet Haematol. 2020 Jan;7(1):e18-e27. doi: 10.1016/S2352-3026(19)30219-4. Epub 2019 Nov 5.
PubMed 31699660
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Rivaroxaban in Pediatric Patients With Deep Venous Thrombosis
- ClinicalTrials.gov ID
- NCT07618988
- Acronym / sponsor ID
- FMASU MD 156/2024
- Conditions
- Pediatric Venous Thromboembolism
- Keywords
- Children, Deep venous thrombosis, Direct oral anticoagulant, anticoagulation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 3 Aug 2024 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 1 May 2026 (actual)
- First posted
- 1 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective interventional randomized controlled trial to assess safety and efficacy of rivaroxaban in pediatric patients with acute deep venous thrombosis.
Detailed description
Treatment of deep venous thrombotic events in children is based on data obtained in adults with little direct documentation of its efficacy and safety in children. Rivaroxaban is a direct oral anticoagulant which has been approved by FDA in 2021 for the use in pediatric patients with venous thrombosis.
In a randomized controlled trial we will study the safety and efficacy of rivaroxaban use in the pediatric population with acute deep venous thrombosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LMWH arm | Active comparator | Drug: Enoxaparin, HeparinPatients assigned to LMWH will receive standard anticoagulation with enoxaparin sodium at a dose 1mg/kg twice daily for 3 months duration. |
| Rivaroxaban | Experimental | Drug: RivaroxabanPatients allocated to Rivaroxaban: after 5 to 9 days of therapy with low molecular weight heparin (LMWH), patients will receive body weight-adjusted 20-mg equivalent doses with an age-appropriate serving of fluid given with or shortly after a meal. Crushed Rivaroxaban tablet is stable for up to 4 hours and displays similar relative bioavailability compared to a whole tablet administered orally. |
Who may qualify
- Ages
- 6 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Patients from 6 months to less than 18 years of age.
- Patients with acute deep venous thrombosis diagnosed based on site-appropriate imaging tools e.g., magnetic resonance venography (MRV) in Cerebral sinus venous thrombosis (CSVT), venous duplex in Central Venous Access Devices (CVAD) related thrombosis or other non-CSVT DVT.
- Patients with cancer associated thrombosis are eligible.
- Patients with provoked or unprovoked acute VT are eligible.
- Patients with first thrombotic event or recurrent VT are eligible.
Key exclusion criteria (9 listed)
- Patients with active bleeding
- High-risk of bleeding including:
- Severe renal impairment (Estimated glomerular filtration rate < 30 mL/min/1.73m2).
- Gastrointestinal disease associated with impaired absorption.
- Hypersensitivity or any other contraindication listed in the local labelling for Rivaroxaban or comparator treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RivaroxabanPatients allocated to Rivaroxaban arm: after 5 to 9 days of therapy with low molecular weight heparin (LMWH), patients will receive body weight-adjusted 20-mg equivalent doses with an age-appropriate serving of fluid given with or shortly after a meal. Crushed Rivaroxaban tablet is stable for up to 4 hours and displays similar relative bioavailability compared to a whole tablet administered orally. | Drug | Rivaroxaban |
| Enoxaparin, HeparinPatients in arm 1 will receive standard anticoagulation with enoxaparin sodium at a dose 1mg/kg twice daily for 3 months duration | Drug | LMWH arm |
Primary outcome
Degree of vein recanalization
Time frame: 3 months
A Repeat site-appropriate imaging at 3 months will be done to assess the degree of vein recanalization and response will be classified as * Normalized: if no residual thrombus is observed, * Improved: if thrombus is still present but partly recanalized or involving less venous segments, * Unchanged: if not recanalized and similar in extent * Deteriorated: if new venous segment involved
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Background: PubMed 27128839Moore KT, Krook MA, Vaidyanathan S, Sarich TC, Damaraju CV, Fields LE. Rivaroxaban crushed tablet suspension characteristics and relative bioavailability in healthy adults when administered orally or via nasogastric tube. Clin Pharmacol Drug Dev. 2014 Jul;3(4):321-7. doi: 10.1002/cpdd.123. Epub 2014 May 16.
- Background: PubMed 30598642Lensing AWA, Male C, Young G, Kubitza D, Kenet G, Patricia Massicotte M, Chan A, Molinari AC, Nowak-Goettl U, Pap AF, Adalbo I, Smith WT, Mason A, Thelen K, Berkowitz SD, Crowther M, Schmidt S, Price V, Prins MH, Monagle P. Rivaroxaban versus standard anticoagulation for acute venous thromboembolism in childhood. Design of the EINSTEIN-Jr phase III study. Thromb J. 2018 Dec 21;16:34. doi: 10.1186/s12959-018-0188-y. eCollection 2018.
- Background: PubMed 32246743Young G, Lensing AWA, Monagle P, Male C, Thelen K, Willmann S, Palumbo JS, Kumar R, Nurmeev I, Hege K, Bajolle F, Connor P, Hooimeijer HL, Torres M, Chan AKC, Kenet G, Holzhauer S, Santamaria A, Amedro P, Beyer-Westendorf J, Martinelli I, Massicotte MP, Smith WT, Berkowitz SD, Schmidt S, Price V, Prins MH, Kubitza D; EINSTEIN-Jr. Phase 3 Investigators. Rivaroxaban for treatment of pediatric venous thromboembolism. An Einstein-Jr phase 3 dose-exposure-response evaluation. J Thromb Haemost. 2020 Jul;18(7):1672-1685. doi: 10.1111/jth.14813. Epub 2020 Jun 4.
- Results publication: PubMed 31699660Male C, Lensing AWA, Palumbo JS, Kumar R, Nurmeev I, Hege K, Bonnet D, Connor P, Hooimeijer HL, Torres M, Chan AKC, Kenet G, Holzhauer S, Santamaria A, Amedro P, Chalmers E, Simioni P, Bhat RV, Yee DL, Lvova O, Beyer-Westendorf J, Biss TT, Martinelli I, Saracco P, Peters M, Kallay K, Gauger CA, Massicotte MP, Young G, Pap AF, Majumder M, Smith WT, Heubach JF, Berkowitz SD, Thelen K, Kubitza D, Crowther M, Prins MH, Monagle P; EINSTEIN-Jr Phase 3 Investigators. Rivaroxaban compared with standard anticoagulants for the treatment of acute venous thromboembolism in children: a randomised, controlled, phase 3 trial. Lancet Haematol. 2020 Jan;7(1):e18-e27. doi: 10.1016/S2352-3026(19)30219-4. Epub 2019 Nov 5.
- Individual participant dataSharing planned: No
Related trials for Pediatric Venous Thromboembolism
Active, not recruitingObservational study
An Observational Study to Learn More About How Safe Rivaroxaban is And How Well it Works in Children With Congenital Heart Disease Who Had a Heart Surgery Called the Fontan Procedure
Prevention of Venous Thromboembolism, Congenital Heart Disease
Not yet recruitingPhase 3
Collaborative Risk-stratified Investigation in Thrombosis-prone Inpatients With Critical Illness: Anticoagulation With LMWH in Teens for ThromboProphylaxis (CRITICAL-Teens-TP).
Venous Thromboembolism (VTE)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fatma SE Ebeid, MD study director
Faculty of Medicine Ain Shams University
Amira Adly principal investigator
Faculty of Medicine Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rivaroxaban and Enoxaparin, Heparin in people with Pediatric Venous Thromboembolism, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of vein recanalization (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07618988, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.