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Trial record 3 of 13 for:    Idarucizumab OR praxbind

CU Programme of Idarucizumab for Japanese Patients

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ClinicalTrials.gov Identifier: NCT02831660
Recruitment Status : Completed
First Posted : July 13, 2016
Results First Posted : March 20, 2018
Last Update Posted : March 20, 2018
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hemorrhage
Intervention Drug: idarucizumab
Enrollment 1
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Idarucizumab 5 g
Hide Arm/Group Description The total dose of 5 g (two 2.5 g vials) was administered intravenously. A single vial contained 2.5 g of idarucizumab (in buffered solution for injection). Patients received a 2.5 g vial of study medication and a second 2.5 g vial within the next 15 minutes. In rare instances, an additional 5 g dose was to be justified.
Period Title: Overall Study
Started 1
Completed 1
Not Completed 0
Arm/Group Title Idarucizumab 5 g
Hide Arm/Group Description The total dose of 5 g (two 2.5 g vials) was administered intravenously. A single vial contained 2.5 g of idarucizumab (in buffered solution for injection). Patients received a 2.5 g vial of study medication and a second 2.5 g vial within the next 15 minutes. In rare instances, an additional 5 g dose was to be justified.
Overall Number of Baseline Participants 1
Hide Baseline Analysis Population Description
Treated set (TS) comprised all patients who had been received at least 1 dose of the study medication.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1 participants
82
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
Female
0
   0.0%
Male
1
 100.0%
1.Primary Outcome
Title Percentage of Subjects With Drug-related Adverse Events
Hide Description Percentage of subjects with drug-related adverse events is presented
Time Frame from first drug administration until 5 days after last drug administration, up to 6 days.
Hide Outcome Measure Data
Hide Analysis Population Description
Treated Set
Arm/Group Title Idarucizumab 5 g
Hide Arm/Group Description:
The total dose of 5 g (two 2.5 g vials) was administered intravenously. A single vial contained 2.5 g of idarucizumab (in buffered solution for injection). Patients received a 2.5 g vial of study medication and a second 2.5 g vial within the next 15 minutes. In rare instances, an additional 5 g dose was to be justified.
Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: Percentage of participants
0.0
Time Frame From first drug administration until 5 days after last drug administration, up to 6 days.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Idarucizumab 5 g
Hide Arm/Group Description The total dose of 5 g (two 2.5 g vials) was administered intravenously. A single vial contained 2.5 g of idarucizumab (in buffered solution for injection). Patients received a 2.5 g vial of study medication and a second 2.5 g vial within the next 15 minutes. In rare instances, an additional 5 g dose was to be justified.
All-Cause Mortality
Idarucizumab 5 g
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Idarucizumab 5 g
Affected / at Risk (%)
Total   0/1 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Idarucizumab 5 g
Affected / at Risk (%)
Total   1/1 (100.00%) 
Investigations   
Platelet count decreased  1  1/1 (100.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.1
Because of the trial design and backgrounds, only 1 patient was entered in the trial. Because of the limited number of patients, it was difficult to draw general conclusion regarding safety or tolerability of idarucizumab
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim
Phone: 1-800-243-0127
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02831660     History of Changes
Other Study ID Numbers: 1321.14
First Submitted: July 11, 2016
First Posted: July 13, 2016
Results First Submitted: August 18, 2017
Results First Posted: March 20, 2018
Last Update Posted: March 20, 2018