Venous ThrombosisPhase 1NCT01145859
Rivaroxaban Pharmacokinetics/Pharmacodynamics (PK/PD) Study in Pediatric Subjects
A Phase 1 study testing Rivaroxaban (Xarelto, BAY59-7939) in people with Venous Thrombosis and Pediatrics, run by Bayer at 36 sites in 10 countries.
Trial summary
The first study with rivaroxaban in pediatric subjects is a Phase I study, where the pharmacokinetic/pharmacodynamic (PK/PD) profile of rivaroxaban will be investigated to confirm that the exposure is comparable to adults. Read more about this study
- Who is it for?
- Ages 6 months to 18 years
- Conditions the study is for
- Venous Thrombosis, Pediatrics
- What is being tested?
- Rivaroxaban (Xarelto, BAY59-7939)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 36 sitesin 10 countries
- Study dates
- Nov 2010to Jul 2015
- Phase
- Phase 1
- 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
- Pediatric subjects > 6 months and < 18 years of age at the time of administration of study drug.
- Patients who have completed treatment of VTE, but are considered to have risk for recurrence of VTE
Who cannot join
- Any major or clinically relevant bleeding during prior VTE treatment
- Abnormal coagulation tests within 7 days prior to study drug administration
- Severe renal impairment
- Planned invasive procedures prior to or after 24 hours of study drug administration
Trial locations and contacts
36 sites in 10 countries.
36 sites in 10 countries
United States16 sites
Study site
Chapel Hill, North Carolina, 27514
Study site
Chicago, Illinois, 60611
Study site
Cleveland, Ohio, 44106-6007
Study site
Detroit, Michigan, 48201-2196
Study site
Durham, North Carolina, 27710
Study site
Gainesville, Florida, 32610
Study site
Indianapolis, Indiana, 46202
Study site
Indianapolis, Indiana, 46260
Study site
Little Rock, Arkansas, 72202-3500
Study site
Los Angeles, California, 90027-6089
Study site
Los Angeles, California, 90095
Study site
New Hyde Park, New York, 11040
Study site
Orange, California, 92868
Study site
Philadelphia, Pennsylvania, 19104
Study site
Pittsburgh, Pennsylvania, 15224
Study site
St. Petersburg, Florida, 33701
France4 sites
Study site
Clermont-Ferrand, 63003
Study site
Montpellier, 34059
Study site
Paris, 75015
Study site
Toulouse, 31059
Italy4 sites
Study site
Genova, 16147
Study site
Milan, 20122
Study site
Pavia, 27100
Study site
Torino, 10126
Canada3 sites
Study site
Edmonton, Alberta, T6G 1C9
Study site
Hamilton, Ontario, L8N 3Z5
Study site
Toronto, Ontario, M5G 1X8
Australia2 sites
Study site
Brisbane, Queensland, 4029
Study site
Parkville, Victoria, 3052
About this study
Official title: Single-dose Pilot Study of Oral Rivaroxaban in Pediatric Subjects With Venous Thromboembolism
The first study with rivaroxaban in pediatric subjects is a Phase I study, where the pharmacokinetic/pharmacodynamic (PK/PD) profile of rivaroxaban will be investigated to confirm that the exposure is comparable to adults. This study is a single dose study with multiple PK/PD measurements in pediatric subjects at the end of their Venous Thromboembolism (VTE) treatment.
- Conditions
- Venous Thrombosis, Pediatrics
- Being tested
- Rivaroxaban (Xarelto, BAY59-7939)
- Keywords
- Venous Thrombosis, Pediatrics
- Medical subject headings
- Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rivaroxaban (Xarelto, BAY59-7939)Drug
Weight adjusted dose with equivalent exposure compared to 10 mg or 20 mg doses in adults
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Rivaroxaban (Xarelto, BAY59-7939) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics parameters (AUC and Cmax)
Measured: From Day 1 to Day 2
Pharmacodynamics parameters (PT, aPTT and anti-factor Xa)
Measured: From Day 1 to Day 2
Secondary outcomes (1)
Safety and tolerability of rivaroxaban in pediatric subjects
Measured: Day 1, day 2 plus 7 days follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2010 (estimated)
- Study startNov 2010
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Venous ThrombosisStudies of the same condition, open and under way.
- More trials run by BayerThe 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 1
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Janssen Research & Development, LLC
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01145859
- Sponsor's protocol ID
- 12892
- Other IDs
- 2009-017313-30, 2009
- Status last verified
- Aug 2015
- First submitted
- 16 Jun 2010
- Last updated
- 6 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Willmann S, Thelen K, Kubitza D, Lensing AWA, Frede M, Coboeken K, Stampfuss J, Burghaus R, Muck W, Lippert J. Pharmacokinetics of rivaroxaban in children using physiologically based and population pharmacokinetic modelling: an EINSTEIN-Jr phase I study. Thromb J. 2018 Dec 4;16:32. doi: 10.1186/s12959-018-0185-1. eCollection 2018.
PubMed 30534008Kubitza D, Willmann S, Becka M, Thelen K, Young G, Brandao LR, Monagle P, Male C, Chan A, Kennet G, Martinelli I, Saracco P, Lensing AWA. Exploratory evaluation of pharmacodynamics, pharmacokinetics and safety of rivaroxaban in children and adolescents: an EINSTEIN-Jr phase I study. Thromb J. 2018 Dec 4;16:31. doi: 10.1186/s12959-018-0186-0. eCollection 2018.
PubMed 30534007Willmann S, Becker C, Burghaus R, Coboeken K, Edginton A, Lippert J, Siegmund HU, Thelen K, Muck W. Development of a paediatric population-based model of the pharmacokinetics of rivaroxaban. Clin Pharmacokinet. 2014 Jan;53(1):89-102. doi: 10.1007/s40262-013-0090-5.
PubMed 23912563
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-dose Pilot Study of Oral Rivaroxaban in Pediatric Subjects With Venous Thromboembolism
- ClinicalTrials.gov ID
- NCT01145859
- Acronym / sponsor ID
- 12892
- Conditions
- Venous Thrombosis, Pediatrics
- Keywords
- Venous Thrombosis, Pediatrics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- Janssen Research & Development, LLC
- Study start
- Nov 2010
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 17 Jun 2010 (estimated)
- 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.
The first study with rivaroxaban in pediatric subjects is a Phase I study, where the pharmacokinetic/pharmacodynamic (PK/PD) profile of rivaroxaban will be investigated to confirm that the exposure is comparable to adults. This study is a single dose study with multiple PK/PD measurements in pediatric subjects at the end of their Venous Thromboembolism (VTE) treatment.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Rivaroxaban (Xarelto, BAY59-7939) |
Who may qualify
- Ages
- 6 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Pediatric subjects > 6 months and < 18 years of age at the time of administration of study drug.
- Patients who have completed treatment of VTE, but are considered to have risk for recurrence of VTE
Key exclusion criteria (4 listed)
- Any major or clinically relevant bleeding during prior VTE treatment
- Abnormal coagulation tests within 7 days prior to study drug administration
- Severe renal impairment
- Planned invasive procedures prior to or after 24 hours of study drug administration
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 |
|---|---|---|
| Rivaroxaban (Xarelto, BAY59-7939)Weight adjusted dose with equivalent exposure compared to 10 mg or 20 mg doses in adults | Drug | Arm 1 |
Primary outcome
Pharmacokinetics parameters (AUC and Cmax)
Time frame: From Day 1 to Day 2
Pharmacodynamics parameters (PT, aPTT and anti-factor Xa)
Time frame: From Day 1 to Day 2
1 secondary outcome
Safety and tolerability of rivaroxaban in pediatric subjects
Time frame: Day 1, day 2 plus 7 days follow up
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 6 Aug 2015.
- Derived from this study: PubMed 30534008Willmann S, Thelen K, Kubitza D, Lensing AWA, Frede M, Coboeken K, Stampfuss J, Burghaus R, Muck W, Lippert J. Pharmacokinetics of rivaroxaban in children using physiologically based and population pharmacokinetic modelling: an EINSTEIN-Jr phase I study. Thromb J. 2018 Dec 4;16:32. doi: 10.1186/s12959-018-0185-1. eCollection 2018.
- Derived from this study: PubMed 30534007Kubitza D, Willmann S, Becka M, Thelen K, Young G, Brandao LR, Monagle P, Male C, Chan A, Kennet G, Martinelli I, Saracco P, Lensing AWA. Exploratory evaluation of pharmacodynamics, pharmacokinetics and safety of rivaroxaban in children and adolescents: an EINSTEIN-Jr phase I study. Thromb J. 2018 Dec 4;16:31. doi: 10.1186/s12959-018-0186-0. eCollection 2018.
- Derived from this study: PubMed 23912563Willmann S, Becker C, Burghaus R, Coboeken K, Edginton A, Lippert J, Siegmund HU, Thelen K, Muck W. Development of a paediatric population-based model of the pharmacokinetics of rivaroxaban. Clin Pharmacokinet. 2014 Jan;53(1):89-102. doi: 10.1007/s40262-013-0090-5.
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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.
Bayer Study Director study director
Bayer
36 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Rivaroxaban (Xarelto, BAY59-7939) in people with Venous Thrombosis and Pediatrics, run by Bayer at 36 sites in 10 countries.
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 2 inclusion and 4 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 6 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in United States, France, Italy, Canada, Australia and 5 more countries. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Pharmacokinetics parameters (AUC and Cmax) (time frame: From Day 1 to Day 2). The study lists 2 primary outcomes in all. 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 NCT01145859, which also lists 3 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 6 Aug 2015.