All-Case Surveillance of Prizbind®

NCT02946931 | Completed Results

• 1 other identifier: 1321.15
• Study Type: observational
• Target: 1,402
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hemorrhage

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

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

  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)

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

Study Arms (1)

Prizbind® for Intravenous Solution

Patients treated with dabigatran etexilate who have uncontrolled bleeding or require emergency surgery or procedures.

Drug: Prizbind®

Interventions

Prizbind® DRUG

Prizbind®

Also known as: Idarucizumab

Prizbind® for Intravenous Solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who are prescribed with Prizbind

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

Unknown Facility

Multiple Locations, Japan

Location

Related Publications (2)

• Yasaka M, Yokota H, Suzuki M, Asakura H, Yamane T, Ogi Y, Kimoto T, Nakayama D. Idarucizumab for Emergency Reversal of the Anticoagulant Effects of Dabigatran: Final Results of a Japanese Postmarketing Surveillance Study. Cardiol Ther. 2023 Dec;12(4):723-740. doi: 10.1007/s40119-023-00333-6. Epub 2023 Oct 17.

  PMID: 37845427 DERIVED

• Yasaka M, Yokota H, Suzuki M, Asakura H, Yamane T, Ogi Y, Ochiai K, Nakayama D. Idarucizumab for Emergency Reversal of Anticoagulant Effects of Dabigatran: Interim Results of a Japanese Post-Marketing Surveillance Study. Cardiol Ther. 2020 Jun;9(1):167-188. doi: 10.1007/s40119-020-00165-8. Epub 2020 Mar 9.

  PMID: 32152956 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Hemorrhage

Interventions

idarucizumab

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2016
• First Posted: October 27, 2016
• Study Start: November 18, 2016
• Primary Completion: November 3, 2020
• Study Completion: November 3, 2020
• Last Updated: September 9, 2022
• Results First Posted: December 15, 2021

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: After structured results have been posted, all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
• Access Criteria: For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.

Locations

JP (1)