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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-002177-37 | EudraCT Number |
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The trial objective is to demonstrate the safety of idarucizumab, as assessed by the occurence of patients with drug related adverse events (including immune reactions) and all-cause mortality in paediatric venous thromboembolism patients treated with dabigatran in ongoing clinical trials who require emergency surgery/urgent procedures or patients who have life-threatening or uncontrolled bleeding which requires urgent intervention, when rapid reversal of the anticoagulant effect of dabigatran is needed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Idarucizumab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Idarucizumab | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Drug-related Adverse Events (AEs) | Number of participants with drug-related adverse events (AEs) including immune reactions and all cause mortality during the trial. | From vial 1 of Idarucizumab until prematurely discontinued of the trial, up to 25 days |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change of Coagulation Time for Diluted Thrombin Time (dTT) and Ecarin Clotting Time (ECT) at 30 Minutes Post-dose Compared With Pre-dose | Percent change of coagulation time for diluted thrombin time (dTT) and ecarin clotting time (ECT) at 30 minutes (min) post-dose compared with pre-dose. Central blood sampling for dTT, ECT were to occur immediately prior to administration of each vial of Idarucizumab and post-dose at 30min, 4h, 12h and 24h. |
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Inclusion criteria:
Patients taking dabigatran etexilate in the paediatric trials 1160.106 or 1160.108 are eligible for this trial if they meet the following criteria:
Group A:
Group B:
Exclusion criteria:
Group A:
Group B:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children Rep.Clin.Hosp of MoH,Cardio Vas.surgery Dept, Kazan | Kazan' | 420138 | Russia | |||
| Regional Clin.Hosp.1,Congen.heart defects&child.Cardiol.dept |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30046708 | Derived | Albisetti M, Schlosser A, Brueckmann M, Gropper S, Glund S, Tartakovsky I, Brandao LR, Reilly PA. Rationale and design of a phase III safety trial of idarucizumab in children receiving dabigatran etexilate for venous thromboembolism. Res Pract Thromb Haemost. 2017 Nov 17;2(1):69-76. doi: 10.1002/rth2.12053. eCollection 2018 Jan. |
| Label | URL |
|---|---|
| Related Info | View source |
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All subjects were screened for eligibility to participants in the trial. Subjects attended specialist sites which would then ensure that they met all strictly implemented inclusion/exclusion criteria. Subjects were not to be assigned to treatment groups if any one of the specific entry criteria were violated.
An open-label, uncontrolled case series trial, with a single treatment arm of idarucizumab in patients with venous thromboembolism treated with dabigatran etexilate in ongoing Boehringer Ingelheim pediatric clinical trials (1160.106 and 1160.108). Treatment period was around 1 day followed by 29 days of safety follow-up period.
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| ID | Title | Description |
|---|---|---|
| FG000 | Idarucizumab | 2.5 gram (g) per 50 milliliter (mL) vial of Idarucizuma was administrated via intravenous injection (vial 1) with (in order of preference): a 5 minutes (min) infusion with an infusion pump, a 10 to 15 min drip, or intravenous push with a syringe followed by another injection (vial 2) of same dosage of Idarucizumab for participants who were treated with dabigatran and had uncontrolled or life threatening bleeding that required urgent medical or surgical intervention or who required emergency surgery/urgent procedures where adequate haemostasis was required (total dosage: up to 5g based on the weight of participant). Two equal injection parts were administered no more than 15 min apart. The time between start of injection of the first vial and end of the second vial was 22 min followed by 24 hours post-dose observation period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
Treated set (TS): including all patients who received any dose of idarucizumab. The TS was used to assess safety, clinical endpoints, demographics and baseline characteristics, concomitant diagnosis/therapy and medical history, and antidrug antibodies (ADA).
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| ID | Title | Description |
|---|---|---|
| BG000 | Idarucizumab | 2.5 gram (g) per 50 milliliter (mL) vial of Idarucizuma was administrated via intravenous injection (vial 1) with (in order of preference): a 5 minutes (min) infusion with an infusion pump, a 10 to 15 min drip, or intravenous push with a syringe followed by another injection (vial 2) of same dosage of Idarucizumab for participants who were treated with dabigatran and had uncontrolled or life threatening bleeding that required urgent medical or surgical intervention or who required emergency surgery/urgent procedures where adequate haemostasis was required (total dosage: up to 5g based on the weight of participant). Two equal injection parts were administered no more than 15 min apart. The time between start of injection of the first vial and end of the second vial was 22 min followed by 24 hours post-dose observation period. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Drug-related Adverse Events (AEs) | Number of participants with drug-related adverse events (AEs) including immune reactions and all cause mortality during the trial. | Treated set (TS): including all patients who received any dose of Idarucizumab. The TS was used to assess safety, clinical endpoints, demographics and baseline characteristics, concomitant diagnosis/therapy and medical history, and antidrug antibodies (ADA). | Posted | Count of Participants | Participants | From vial 1 of Idarucizumab until prematurely discontinued of the trial, up to 25 days |
|
From vial 1 of Idarucizumab until prematurely discontinued of the trial, up to 25 days
Treated set (TS): including all patients who received any dose of Idarucizumab. The TS was used to assess safety, clinical endpoints, demographics and baseline characteristics, concomitant diagnosis/therapy and medical history, and antidrug antibodies (ADA).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Idarucizumab | 2.5 gram (g) per 50 milliliter (mL) vial of Idarucizuma was administrated via intravenous injection (vial 1) with (in order of preference): a 5 minutes (min) infusion with an infusion pump, a 10 to 15 min drip, or intravenous push with a syringe followed by another injection (vial 2) of same dosage of Idarucizumab for participants who were treated with dabigatran and had uncontrolled or life threatening bleeding that required urgent medical or surgical intervention or who required emergency surgery/urgent procedures where adequate haemostasis was required (total dosage: up to 5g based on the weight of participant). Two equal injection parts were administered no more than 15 min apart. The time between start of injection of the first vial and end of the second vial was 22 min followed by 24 hours post-dose observation period. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 22.1 | Systematic Assessment |
The patient completed the treatment period, but the end-of-trial visit was by mistake scheduled 5 days earlier. Thus, the patient was formally considered as having prematurely discontinued the trial although all planned visits were performed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 4, 2016 | Mar 25, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 31, 2017 | Mar 25, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000594745 | idarucizumab |
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| At immediately prior to administration of vial 1 of Idarucizumab and 30 minutes (min) post vial 2 administration. |
| Time to Achieve Reversal of the Dabigatran Effect (Based on the Coagulation Time for dTT and ECT) | Idarucizumab administration resulted in normalisation of dTT and ECT. Time to achieve reversal of anticoagulant effect of dabigatran based on the coagulation time for dTT and ECT, at any time point from the end of the second injection (vial 2) up to 24 hours (h). Reversal of the dabigatran effect at time t was defined as the 100 percent (%) *(pre-dose coagulation time - post-dose coagulation time at time t)/(pre-dose coagulation test - upper limit of normal). Values equal to or higher than 100% were interpreted as reversal. Central blood sampling for dTT, ECT were to occur immediately prior to administration of each vial of Idarucizumab and post-dose at 30min, 4h, 12h and 24h. | From end of vial 2 of Idarucizumab up to 24h. |
| Duration of Reversal of the Dabigatran Effect Sustained up to 24 Hours Post-dose (Based on the Coagulation Time for dTT and ECT) | Duration of reversal, defined as the time period a patient remained completely reversed based on dTT and ECT, up to 24 hours post-dose or restarting the treatment of anticoagulation. Central blood sampling for dTT, ECT were to occur immediately prior to administration of each vial of idarucizumab and post-dose at 30min, 4h, 12h and 24h. | From end of vial 2 of Idarucizumab up to 24h. |
| Number of Participants With Cessation of Bleeding | From vial 1 of Idarucizumab through vial 2 of Idarucizumab, up to 24h 30min. |
| Number of Participants Per Bleeding Status During the Trial | Numbers of participants whose bleeding had stopped, reduced, unchanged, worsened or not applicable during the trial were characterized. | From vial 1 of Idarucizumab until prematurely discontinued of the trial, up to 25 days |
| Number of Participants With Clinical Conditions Contributing to Bleeding During the Trial | Number of participants with clinical conditions (trauma, surgery and use of antiplatelet) contributing to bleeding during the trial were characterized. | From vial 1 of Idarucizumab until prematurely discontinued of the trial, up to 25 days |
| Number of Participants Developing Treatment-emergent Antidrug Antibodies (ADA) With Cross Reactivity to Idarucizumab | At day 25 post vial 2 of Idarucizumab administration, up to 1 day |
| Tyumen |
| 625021 |
| Russia |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Secondary | Percent Change of Coagulation Time for Diluted Thrombin Time (dTT) and Ecarin Clotting Time (ECT) at 30 Minutes Post-dose Compared With Pre-dose | Percent change of coagulation time for diluted thrombin time (dTT) and ecarin clotting time (ECT) at 30 minutes (min) post-dose compared with pre-dose. Central blood sampling for dTT, ECT were to occur immediately prior to administration of each vial of Idarucizumab and post-dose at 30min, 4h, 12h and 24h. | Pharmacodynamic (PD) set (PDS): comprising all patients in the TS who provided at least 1 evaluable pre-dose and at least 1 post-dose observation for PD endpoints or biomarker measures. The PDS was used for the PD endpoint analyses. Note that for different PD endpoints or biomarkers, the number of evaluable patients could differ between endpoints. | Posted | Number | Percentage of time in seconds | At immediately prior to administration of vial 1 of Idarucizumab and 30 minutes (min) post vial 2 administration. |
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| Secondary | Time to Achieve Reversal of the Dabigatran Effect (Based on the Coagulation Time for dTT and ECT) | Idarucizumab administration resulted in normalisation of dTT and ECT. Time to achieve reversal of anticoagulant effect of dabigatran based on the coagulation time for dTT and ECT, at any time point from the end of the second injection (vial 2) up to 24 hours (h). Reversal of the dabigatran effect at time t was defined as the 100 percent (%) *(pre-dose coagulation time - post-dose coagulation time at time t)/(pre-dose coagulation test - upper limit of normal). Values equal to or higher than 100% were interpreted as reversal. Central blood sampling for dTT, ECT were to occur immediately prior to administration of each vial of Idarucizumab and post-dose at 30min, 4h, 12h and 24h. | Pharmacodynamic (PD) set (PDS): comprising all patients in the TS who provided at least 1 evaluable pre-dose and at least 1 post-dose observation for PD endpoints or biomarker measures. The PDS was used for the PD endpoint analyses. Note that for different PD endpoints or biomarkers, the number of evaluable patients could differ between endpoints. | Posted | Number | Minutes | From end of vial 2 of Idarucizumab up to 24h. |
|
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| Secondary | Duration of Reversal of the Dabigatran Effect Sustained up to 24 Hours Post-dose (Based on the Coagulation Time for dTT and ECT) | Duration of reversal, defined as the time period a patient remained completely reversed based on dTT and ECT, up to 24 hours post-dose or restarting the treatment of anticoagulation. Central blood sampling for dTT, ECT were to occur immediately prior to administration of each vial of idarucizumab and post-dose at 30min, 4h, 12h and 24h. | Pharmacodynamic (PD) set (PDS): comprising all patients in the TS who provided at least 1 evaluable pre-dose and at least 1 post-dose observation for PD endpoints or biomarker measures. The PDS was used for the PD endpoint analyses. Note that for different PD endpoints or biomarkers, the number of evaluable patients could differ between endpoints. | Posted | Number | Hours | From end of vial 2 of Idarucizumab up to 24h. |
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| Secondary | Number of Participants With Cessation of Bleeding | Treated set (TS): including all patients who received any dose of Idarucizumab. The TS was used to assess safety, clinical endpoints, demographics and baseline characteristics, concomitant diagnosis/therapy and medical history, as well as ADA. | Posted | Count of Participants | Participants | From vial 1 of Idarucizumab through vial 2 of Idarucizumab, up to 24h 30min. |
|
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| Secondary | Number of Participants Per Bleeding Status During the Trial | Numbers of participants whose bleeding had stopped, reduced, unchanged, worsened or not applicable during the trial were characterized. | Treated set (TS): including all patients who received any dose of Idarucizumab. The TS was used to assess safety, clinical endpoints, demographics and baseline characteristics, concomitant diagnosis/therapy and medical history, as well as ADA. | Posted | Count of Participants | Participants | From vial 1 of Idarucizumab until prematurely discontinued of the trial, up to 25 days |
|
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| Secondary | Number of Participants With Clinical Conditions Contributing to Bleeding During the Trial | Number of participants with clinical conditions (trauma, surgery and use of antiplatelet) contributing to bleeding during the trial were characterized. | Treated set (TS): including all patients who received any dose of Idarucizumab. The TS was used to assess safety, clinical endpoints, demographics and baseline characteristics, concomitant diagnosis/therapy and medical history, as well as ADA. | Posted | Count of Participants | Participants | From vial 1 of Idarucizumab until prematurely discontinued of the trial, up to 25 days |
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| Secondary | Number of Participants Developing Treatment-emergent Antidrug Antibodies (ADA) With Cross Reactivity to Idarucizumab | Treated set (TS): including all patients who received any dose of Idarucizumab. The TS was used to assess safety, clinical endpoints, demographics and baseline characteristics, concomitant diagnosis/therapy and medical history, as well as ADA. | Posted | Count of Participants | Participants | At day 25 post vial 2 of Idarucizumab administration, up to 1 day |
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| 0 |
| 1 |
| 0 |
| 1 |
| 1 |
| 1 |
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
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| Worsened |
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| Not applicable |
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