All-Case Surveillance of Prizbind®

Hemorrhage Clinical Trial

Official title:

The Drug Use-results Survey (All-Case Surveillance) on Prizbind® for Intravenous Solution 2.5 g in Japan

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02946931
• Other study ID #: 1321.15
• Status: Completed
• Start date: November 18, 2016
• Est. completion date: November 3, 2020

Study information

• Verified date: August 2022
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To evaluate safety and effectiveness of Prizbind® for Intravenous Solution 2.5 g under Japanese clinical condition.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1402
• Est. completion date: November 3, 2020
• Est. primary completion date: November 3, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

Patients who are prescribed with Prizbind® for Intravenous Solution 2.5 g by the discretion of investigators

Exclusion criteria:

None

Related Conditions & MeSH terms

• Hemorrhage

Intervention

Drug:
• Prizbind®
Prizbind®

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients With Adverse Drug Reactions (ADRs)	Adverse reaction was defined as a response to the medicinal product which was noxious and unintended. Number of participants with Adverse Drug Reactions (ADRs) is reported.	From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Secondary	Maximum Reversal of Anticoagulation as Measured by Activated Partial Thromboplastin Time (aPTT)	Maximum reversal of anticoagulation as measured by activated partial thromboplastin time (aPTT) is reported.; Maximum reversal was calculated as:{(predose aPTT - minimum postdose aPTT)/(predose aPTT - upper limit of normal (ULN))} × 100%. If calculated reversal is > 100, it was set to 100.	From the end of the first infusion up to 4 hours after the last infusion on Day 1.
Secondary	Number of Patients in Each Category of Maximum Reversal of Anticoagulation as Measured by Activated Partial Thromboplastin Time (aPTT)	Number of patients in each category of maximum reversal of anticoagulation as measured by activated partial thromboplastin time (aPTT) is reported.; Maximum reversal was calculated as:{(predose aPTT - minimum postdose aPTT)/(predose aPTT - upper limit of normal (ULN))} × 100%. If calculated reversal is > 100, it was set to 100.; Maximum Reversal was categorized in the following 4 categories: 100% 80% <= and < 100% 50% <= and < 80% < 50%	From the end of the first infusion up to 4 hours after the last infusion on Day 1.

External Links

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