HemorrhageNCT02946931
All-Case Surveillance of Prizbind®
An observational study of Hemorrhage, run by Boehringer Ingelheim at 1 site in Japan.
Trial summary
To evaluate safety and effectiveness of Prizbind® for Intravenous Solution 2.5 g under Japanese clinical condition. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemorrhage
- What is being tested?
- Prizbind®
- How many people
- 1,402 participants
- Where
- 1 siteJapan
- Study dates
- 18 Nov 2016to 3 Nov 2020
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are prescribed with Prizbind
Who may be able to join
- Patients who are prescribed with Prizbind® for Intravenous Solution 2.5 g by the discretion of investigators
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Drug Use-results Survey (All-Case Surveillance) on Prizbind® for Intravenous Solution 2.5 g in Japan
To evaluate safety and effectiveness of Prizbind® for Intravenous Solution 2.5 g under Japanese clinical condition.
- Conditions
- Hemorrhage
- Being tested
- Prizbind®
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prizbind®Drug
Also called Idarucizumab
Prizbind®
| Study group | Role | What they receive |
|---|---|---|
| Prizbind® for Intravenous Solution | Patients treated with dabigatran etexilate who have uncontrolled bleeding or require emergency surgery or procedures. Receives: Drug: Prizbind® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 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)
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%
Measured: From the end of the first infusion up to 4 hours after the last infusion on Day 1.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2016 (estimated)
- Study start18 Nov 2016
- Primary completion3 Nov 2020
- Study completion3 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HemorrhageStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,402 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02946931
- Sponsor's protocol ID
- 1321.15
- Status last verified
- Aug 2022
- First submitted
- 25 Oct 2016
- Last updated
- 9 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- Yes
Publications
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.
PubMed 37845427Yasaka 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.
PubMed 32152956
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Drug Use-results Survey (All-Case Surveillance) on Prizbind® for Intravenous Solution 2.5 g in Japan
- ClinicalTrials.gov ID
- NCT02946931
- Acronym / sponsor ID
- 1321.15
- Conditions
- Hemorrhage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,402 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 18 Nov 2016 (actual)
- Primary completion
- 3 Nov 2020 (actual)
- Study completion
- 3 Nov 2020 (actual)
- First posted
- 27 Oct 2016 (estimated)
- Results
- Posted 15 Dec 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate safety and effectiveness of Prizbind® for Intravenous Solution 2.5 g under Japanese clinical condition.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prizbind® for Intravenous Solution | – | Drug: Prizbind®Patients treated with dabigatran etexilate who have uncontrolled bleeding or require emergency surgery or procedures. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are prescribed with Prizbind
Key inclusion criteria (1 listed)
- Patients who are prescribed with Prizbind® for Intravenous Solution 2.5 g by the discretion of investigators
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prizbind®Also: IdarucizumabPrizbind® | Drug | Prizbind® for Intravenous Solution |
Primary outcome
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.
2 secondary outcomes
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)
Time frame: From the end of the first infusion up to 4 hours after the last infusion on Day 1.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37845427Yasaka 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.
- Derived from this study: PubMed 32152956Yasaka 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boehringer Ingelheim study chair
Boehringer Ingelheim
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemorrhage, run by Boehringer Ingelheim at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02946931, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2022.