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OpenTrials
Completed

NCT Number: NCT02946931

All-Case Surveillance of Prizbind®

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

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Key information

Conditions

Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Multiple Locations, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

None

Treatment and study plan

Prizbind®

Drug

Prizbind®

Other names: Idarucizumab

Primary outcomes

  1. Number of Patients With Adverse Drug Reactions (ADRs)

    Time frame: 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.

    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.

Secondary outcomes

  1. Maximum Reversal of Anticoagulation as Measured by Activated Partial Thromboplastin Time (aPTT)

    Time frame: From the end of the first infusion up to 4 hours after the last infusion on Day 1.

    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.

  2. Number of Patients in Each Category of Maximum Reversal of Anticoagulation as Measured by Activated Partial Thromboplastin Time (aPTT)

    Time frame: From the end of the first infusion up to 4 hours after the last infusion on Day 1.

    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%

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Oct 27, 2016
Registry last updated
Sep 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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