Trial Outcomes & Findings for CU Programme of Idarucizumab for Japanese Patients (NCT NCT02831660)

Results Overview

Percentage of subjects with drug-related adverse events is presented

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1 participants

Primary outcome timeframe

from first drug administration until 5 days after last drug administration, up to 6 days.

Results posted on

2018-03-20

Participant milestones
Measure	Idarucizumab 5 g 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 Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Withdrawal data not reported

CU Programme of Idarucizumab for Japanese Patients

Baseline characteristics by cohort
Measure	Idarucizumab 5 g n=1 Participants 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.
Age, Continuous	82 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants

Timeframe: from first drug administration until 5 days after last drug administration, up to 6 days.

Population: Treated Set

Percentage of subjects with drug-related adverse events is presented

Outcome measures
Measure	Idarucizumab 5 g n=1 Participants 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.
Percentage of Subjects With Drug-related Adverse Events	0.0 Percentage of participants

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Idarucizumab 5 g n=1 participants at risk 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.
Investigations Platelet count decreased	100.0% 1/1 • From first drug administration until 5 days after last drug administration, up to 6 days.

Boehringer Ingelheim

Phone: 1-800-243-0127

Principal investigator is a sponsor employee 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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