HemorrhagePhase 3NCT02831660
CU Programme of Idarucizumab for Japanese Patients
A Phase 3 study testing idarucizumab in people with Hemorrhage, run by Boehringer Ingelheim at 1 site in Japan.
Trial summary
The objective is to collect the safety data of idarucizumab for patients treated with dabigatran who require rapid reversal of the anticoagulant effects of dabigatran in cases of uncontrolled or life-threatening bleeding or when emergency surgery or urgent procedures are required. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hemorrhage
- What is being tested?
- idarucizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteJapan
- Study dates
- 22 Jul 2016to 16 Sep 2016
- Phase
- Phase 3
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Currently taking dabigatran etexilate.
- Age >= 20 years at entry.
- Written Informed consent
- Group A:
- -- Uncontrolled or life-threatening judged by the physician to require a reversal agent.
- Group B:
- A condition requiring emergency surgery or invasive procedure where adequate hemostasis is required. Emergency is defined as within the following 8 hours.
Who cannot join
- Contraindications to study medication including known hypersensitivity to the drug or its excipients (subjects with hereditary fructose intolerance may react to sorbitol).
- Group A:
- Patients with minor bleeding (e.g. epistaxis, hematuria) who can be managed with standard supportive care.
- Patients with no clinical signs of bleeding.
- Group B:
- surgery or procedure which is elective or where the risk of uncontrolled or unmanageable bleeding is low.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Compassionate Use Program of Idarucizumab for Reversal of the Anticoagulant Effects of Dabigatran in Japanese Patients Who Have Uncontrolled Bleeding or Require Emergency Surgery or Procedures
The objective is to collect the safety data of idarucizumab for patients treated with dabigatran who require rapid reversal of the anticoagulant effects of dabigatran in cases of uncontrolled or life-threatening bleeding or when emergency surgery or urgent procedures are required.
- Conditions
- Hemorrhage
- Being tested
- idarucizumab
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
idarucizumabDrug
| Study group | Role | What they receive |
|---|---|---|
| idarucizumab | Experimental | Not described Receives: Drug: idarucizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects With Drug-related Adverse Events
Percentage of subjects with drug-related adverse events is presented
Measured: from first drug administration until 5 days after last drug administration, up to 6 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2016 (estimated)
- Study start22 Jul 2016
- Primary completion16 Sep 2016
- Study completion16 Sep 2016
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.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 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
- NCT02831660
- Sponsor's protocol ID
- 1321.14
- Status last verified
- Mar 2018
- First submitted
- 11 Jul 2016
- Last updated
- 20 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Compassionate Use Program of Idarucizumab for Reversal of the Anticoagulant Effects of Dabigatran in Japanese Patients Who Have Uncontrolled Bleeding or Require Emergency Surgery or Procedures
- ClinicalTrials.gov ID
- NCT02831660
- Acronym / sponsor ID
- 1321.14
- Conditions
- Hemorrhage
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 22 Jul 2016 (actual)
- Primary completion
- 16 Sep 2016 (actual)
- Study completion
- 16 Sep 2016 (actual)
- First posted
- 13 Jul 2016 (estimated)
- Results
- Posted 20 Mar 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective is to collect the safety data of idarucizumab for patients treated with dabigatran who require rapid reversal of the anticoagulant effects of dabigatran in cases of uncontrolled or life-threatening bleeding or when emergency surgery or urgent procedures are required.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| idarucizumab | Experimental | Drug: idarucizumab |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Currently taking dabigatran etexilate.
- Age >= 20 years at entry.
- Written Informed consent
- Group A:
- -- Uncontrolled or life-threatening judged by the physician to require a reversal agent.
Key exclusion criteria (6 listed)
- Contraindications to study medication including known hypersensitivity to the drug or its excipients (subjects with hereditary fructose intolerance may react to sorbitol).
- Group A:
- Group B:
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 |
|---|---|---|
| idarucizumab | Drug | idarucizumab |
Primary outcome
Percentage of Subjects With Drug-related Adverse Events
Time frame: from first drug administration until 5 days after last drug administration, up to 6 days.
Percentage of subjects with drug-related adverse events is presented
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
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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?
A Phase 3 study testing idarucizumab in people with 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 7 inclusion and 6 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 20 Mar 2018. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Mar 2018). 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?
Percentage of Subjects With Drug-related Adverse Events (time frame: from first drug administration until 5 days after last drug administration, up to 6 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Mar 2018.