HemorrhageNCT02798107
Observational Study to Evaluate Safety of Idarucizumab in Pediatric Patients
An observational study of Hemorrhage, run by Boehringer Ingelheim.
Trial summary
Idarucizumab is a humanized monoclonal antibody fragment (Fab) that binds to dabigatran with very high affinity. Idarucizumab potently and specifically binds to dabigatran and its metabolites and neutralises its anticoagulant effect. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Hemorrhage
- What is being tested?
- idarucizumab
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 20 May 2019to 24 May 2019
- Phase
- Observational
- 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 Up to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Any pediatric patient who has received a commercial supply of idarucizumab following market approval in their country
Who may be able to join
- Male or female, <18 years of age
- Were administered idarucizumab at sites and usage identified by various methods (eg.through the Idarucizumab drug administration surveillance program, spontaneous reporting)
Who cannot join
- Participation in a dabigatran or idarucizumab clinical trial
About this study
Official title: Safety of Potential Paediatric Patients Treated With Idarucizumab: a Non-internventional Chart Review Study
Idarucizumab is a humanized monoclonal antibody fragment (Fab) that binds to dabigatran with very high affinity. Idarucizumab potently and specifically binds to dabigatran and its metabolites and neutralises its anticoagulant effect. A clinical development program is ongoing to support marketing authorisation submissions for idarucizumab indicated in patients treated with dabigatran who require emergency surgery/urgent procedures or who have a life-threatening or uncontrolledbleeding when rapid reversal of the anticoagulant effects of dabigatran is required.
Read the detailed description
Purpose:
Study Design:
- Conditions
- Hemorrhage
- Being tested
- idarucizumab
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
idarucizumabDrug
drug
| Study group | Role | What they receive |
|---|---|---|
| All patients treated with idarucizumab | Not described Receives: Drug: idarucizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety outcomes until hospital discharge * Incidence of thromboembolic events (ie. obstruction of a blood vessel by the formation of a thrombus - e.g. ischemic stroke, MI, DVT, PE) after administration
Measured: Up to 33 months
Safety outcomes until hospital discharge * Incidence of hypersensitivity/anaphylactic reactions
Measured: Up to 33 months
Safety outcomes until hospital discharge * Incidence of AE, SAE, ADR, SADR reporting
Measured: Up to 33 months
Safety outcomes until hospital discharge * Cause of death and in-hospital mortality rate
Measured: Up to 33 months
Secondary outcomes (4)
Comparison of patient characteristics of paediatric patients with & without outcome events * Incidence of thromboembolic events (ie. obstruction of a blood vessel by the formation of a thrombus - e.g. ischemic stroke, MI, DVT, PE) after administration
Measured: Up to 33 months
Comparison of patient characteristics of paediatric patients with & without outcome events * Incidence of hypersensitivity/anaphylactic reactions
Measured: Up to 33 months
Comparison of patient characteristics of paediatric patients with & without outcome events * Incidence of AE, SAE, ADR, SADR reporting
Measured: Up to 33 months
Comparison of patient characteristics of paediatric patients with & without outcome events * Cause of death and in-hospital mortality rate
Measured: Up to 33 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2016 (estimated)
- Study start20 May 2019 (estimated)
- Primary completion23 May 2019 (estimated)
- Study completion24 May 2019 (estimated)
Why it stopped: No recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemorrhageStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02798107
- Sponsor's protocol ID
- 1321.11
- Status last verified
- Nov 2021
- First submitted
- 10 Jun 2016
- Last updated
- 18 Nov 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions: 1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datasharing
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Potential Paediatric Patients Treated With Idarucizumab: a Non-internventional Chart Review Study
- ClinicalTrials.gov ID
- NCT02798107
- Acronym / sponsor ID
- 1321.11
- Conditions
- Hemorrhage
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No recruitment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 20 May 2019 (estimated)
- Primary completion
- 23 May 2019 (estimated)
- Study completion
- 24 May 2019 (estimated)
- First posted
- 14 Jun 2016 (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.
Idarucizumab is a humanized monoclonal antibody fragment (Fab) that binds to dabigatran with very high affinity. Idarucizumab potently and specifically binds to dabigatran and its metabolites and neutralises its anticoagulant effect. A clinical development program is ongoing to support marketing authorisation submissions for idarucizumab indicated in patients treated with dabigatran who require emergency surgery/urgent procedures or who have a life-threatening or uncontrolledbleeding when rapid reversal of the anticoagulant effects of dabigatran is required.
Detailed description
Purpose:
Study Design:
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients treated with idarucizumab | – | Drug: idarucizumab |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Any pediatric patient who has received a commercial supply of idarucizumab following market approval in their country
Key inclusion criteria (2 listed)
- Male or female, <18 years of age
- Were administered idarucizumab at sites and usage identified by various methods (eg.through the Idarucizumab drug administration surveillance program, spontaneous reporting)
Key exclusion criteria (1 listed)
- Participation in a dabigatran or idarucizumab clinical trial
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 |
|---|---|---|
| idarucizumabdrug | Drug | All patients treated with idarucizumab |
Primary outcome
Safety outcomes until hospital discharge * Incidence of thromboembolic events (ie. obstruction of a blood vessel by the formation of a thrombus - e.g. ischemic stroke, MI, DVT, PE) after administration
Time frame: Up to 33 months
Safety outcomes until hospital discharge * Incidence of hypersensitivity/anaphylactic reactions
Time frame: Up to 33 months
Safety outcomes until hospital discharge * Incidence of AE, SAE, ADR, SADR reporting
Time frame: Up to 33 months
Safety outcomes until hospital discharge * Cause of death and in-hospital mortality rate
Time frame: Up to 33 months
4 secondary outcomes
Comparison of patient characteristics of paediatric patients with & without outcome events * Incidence of thromboembolic events (ie. obstruction of a blood vessel by the formation of a thrombus - e.g. ischemic stroke, MI, DVT, PE) after administration
Time frame: Up to 33 months
Comparison of patient characteristics of paediatric patients with & without outcome events * Incidence of hypersensitivity/anaphylactic reactions
Time frame: Up to 33 months
Comparison of patient characteristics of paediatric patients with & without outcome events * Incidence of AE, SAE, ADR, SADR reporting
Time frame: Up to 33 months
Comparison of patient characteristics of paediatric patients with & without outcome events * Cause of death and in-hospital mortality rate
Time frame: Up to 33 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2021.
- Individual participant dataSharing planned: No. Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions: 1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datasharing
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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.
Boehringer Ingelheim study chair
Boehringer Ingelheim
Questions about this trial
What is this clinical trial studying?
An observational study of Hemorrhage, run by Boehringer Ingelheim.
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 1 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: withdrawn, as of the sponsor's last update on 18 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Safety outcomes until hospital discharge * Incidence of thromboembolic events (ie. obstruction of a blood vessel by the formation of a thrombus - e.g. ischemic stroke, MI, DVT, PE) after administration (time frame: Up to 33 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Nov 2021.