Venous ThromboembolismPhase 2NCT02170701
BIBR 1048 in the Prevention of Venous Thromboembolism in Patients Undergoing Primary Elective Total Hip Replacement Surgery
A Phase 2 study testing BIBR 1048 in people with Venous Thromboembolism, run by Boehringer Ingelheim.
Trial summary
To determine the therapeutic window of BIBR 1048 in order to select doses for further studies in the development plan. Twice daily regimen will be tested for most dose levels and once daily administration will also be evaluated when appropriate. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thromboembolism
- What is being tested?
- BIBR 1048
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 289 participants
- Where
- No sites listed yet
- Study dates
- Oct 2000to Jun 2001
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
Who may be able to join
- Patients scheduled to undergo a primary elective total hip replacement
- Male of female being 18 years or older
- Patients weighing at least 40 kg
- Written informed consent for study participation
Who cannot join
- Bleeding diathesis, constitutional or acquired coagulation disorders
- Major surgery or trauma (e.g. hip fracture) within the last three months. Patients with previous hip fractures associated with plate revisions at any time will be excluded
- Cardiovascular disease including uncontrolled hypertension at time of enrolment or history of myocardial infarction within the last 6 months
- Any history of haemorrhagic stroke, intracranial or intraocular bleeding or cerebral ischaemic attacks
- Known history of deep venous thrombosis (DVT)
- Gastrointestinal or pulmonary bleeding within the last year
Show all 18Show fewer
- Known liver disease Aspartate transaminase (AST) or Alanine transaminase (ALT) > 3 x ULN)
- Known renal disease (serum creatinine > 1.5 x ULN)
- Use of long- term anticoagulants, antiplatelet drugs, or fibrinolytics within 7 days prior to hip replacement operation (also contraindicated during the period of prophylaxis)
- Women of childbearing potential
- Known allergy to radiopaque contrast media
- Known thrombocytopenia (prior platelet count below 100,000 cells/microliter)
- Active malignant disease
- Current H2 blocker or proton pump inhibitor treatment
- Current cytostatic treatment
- Treatment with an investigational drug in the past month
- Leg amputee
- Known alcohol or drug abuse
About this study
Official title: Multicenter, Open-label, Ascending Dose Study of BIBR 1048 in the Prevention of Venous Thromboembolism in Patients Undergoing Primary Elective Total Hip Replacement Surgery. Bistro I
- To determine the therapeutic window of BIBR 1048 in order to select doses for further studies in the development plan.
- Twice daily regimen will be tested for most dose levels and once daily administration will also be evaluated when appropriate.
- Conditions
- Venous Thromboembolism
- Being tested
- BIBR 1048
- Medical subject headings
- Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIBR 1048Drug
Ascending doses (in mg) given twice daily
| Study group | Role | What they receive |
|---|---|---|
| BIBR 1048 | Experimental | Ascending doses (in mg) given twice daily Receives: Drug: BIBR 1048 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of venous thrombolic events
Measured: Up to day 10 after hip surgery
Changes from baseline in activated partial thromboplastin time (aPTT)
Measured: From baseline (day -14 to day -1 before treatment) until last day of treatment (up to day 10)
Changes from baseline in ecarin clotting time (ECT)
Measured: From baseline (day -14 to day -1 before treatment) until last day of treatment (up to day 10)
Changes from baseline in thrombin time (TT)
Measured: From baseline (day -14 to day -1 before treatment) until last day of treatment (up to day 10)
Rate of major bleeding events during treatment phase
Measured: Start of treatment (day 0) until end of treatment (up to day 10)
Cpre,ss (predose plasma concentrations at steady state)
Measured: baseline and predose from day 1 to last treatment day
Cmax,ss (maximum plasma concentration at steady state (day 4))
Measured: Day 4
Tmax,ss (time to reach Cmax,ss)
Measured: baseline, day 0 before and 4 hours after, day 1 to 4 before and 2 h after treatment, day 5 to last treatment day before treatment
CLtot/f (total clearance of drug from plasma after oral administration)
Measured: baseline, day 0 before and 4 hours after, day 1 to 4 before and 2 h after treatment, day 5 to last treatment day before treatment
AUCss (area under the plasma concentration curve of one dosing interval at steady state)
Measured: baseline, day 0 before and 4 hours after, day 1 to 4 before and 2 h after treatment, day 5 to last treatment day before treatment
PTF (percent peak trough fluctuation for the last dosing interval)
Measured: baseline, day 0 before and 4 hours after, day 1 to 4 before and 2 h after treatment, day 5 to last treatment day before treatment
Cmax,ss (maximum plasma concentration at steady state (day 4))
Measured: Day 4 before and 0.5, 1, 2, 4 , 8, 12 , 14 h after treatment
Secondary outcomes (1)
Venous thromboembolism diagnosed during the follow-up period
Measured: Up to 6 weeks after surgery (day 42)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2014 (estimated)
- Study startOct 2000
- Primary completionJun 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous ThromboembolismStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 289 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02170701
- Sponsor's protocol ID
- 1160.11
- Status last verified
- Aug 2018
- First submitted
- 20 Jun 2014
- Last updated
- 31 Aug 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Open-label, Ascending Dose Study of BIBR 1048 in the Prevention of Venous Thromboembolism in Patients Undergoing Primary Elective Total Hip Replacement Surgery. Bistro I
- ClinicalTrials.gov ID
- NCT02170701
- Acronym / sponsor ID
- 1160.11
- Conditions
- Venous Thromboembolism
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 289 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Oct 2000
- Primary completion
- Jun 2001 (actual)
- First posted
- 23 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- To determine the therapeutic window of BIBR 1048 in order to select doses for further studies in the development plan.
- Twice daily regimen will be tested for most dose levels and once daily administration will also be evaluated when appropriate.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BIBR 1048 | Experimental | Drug: BIBR 1048Ascending doses (in mg) given twice daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients scheduled to undergo a primary elective total hip replacement
- Male of female being 18 years or older
- Patients weighing at least 40 kg
- Written informed consent for study participation
Key exclusion criteria (18 listed)
- Bleeding diathesis, constitutional or acquired coagulation disorders
- Major surgery or trauma (e.g. hip fracture) within the last three months. Patients with previous hip fractures associated with plate revisions at any time will be excluded
- Cardiovascular disease including uncontrolled hypertension at time of enrolment or history of myocardial infarction within the last 6 months
- Any history of haemorrhagic stroke, intracranial or intraocular bleeding or cerebral ischaemic attacks
- Known history of deep venous thrombosis (DVT)
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 |
|---|---|---|
| BIBR 1048Ascending doses (in mg) given twice daily | Drug | BIBR 1048 |
Primary outcome
Rate of venous thrombolic events
Time frame: Up to day 10 after hip surgery
Changes from baseline in activated partial thromboplastin time (aPTT)
Time frame: From baseline (day -14 to day -1 before treatment) until last day of treatment (up to day 10)
Changes from baseline in ecarin clotting time (ECT)
Time frame: From baseline (day -14 to day -1 before treatment) until last day of treatment (up to day 10)
Changes from baseline in thrombin time (TT)
Time frame: From baseline (day -14 to day -1 before treatment) until last day of treatment (up to day 10)
Rate of major bleeding events during treatment phase
Time frame: Start of treatment (day 0) until end of treatment (up to day 10)
Cpre,ss (predose plasma concentrations at steady state)
Time frame: baseline and predose from day 1 to last treatment day
Cmax,ss (maximum plasma concentration at steady state (day 4))
Time frame: Day 4
Tmax,ss (time to reach Cmax,ss)
Time frame: baseline, day 0 before and 4 hours after, day 1 to 4 before and 2 h after treatment, day 5 to last treatment day before treatment
CLtot/f (total clearance of drug from plasma after oral administration)
Time frame: baseline, day 0 before and 4 hours after, day 1 to 4 before and 2 h after treatment, day 5 to last treatment day before treatment
AUCss (area under the plasma concentration curve of one dosing interval at steady state)
Time frame: baseline, day 0 before and 4 hours after, day 1 to 4 before and 2 h after treatment, day 5 to last treatment day before treatment
PTF (percent peak trough fluctuation for the last dosing interval)
Time frame: baseline, day 0 before and 4 hours after, day 1 to 4 before and 2 h after treatment, day 5 to last treatment day before treatment
Cmax,ss (maximum plasma concentration at steady state (day 4))
Time frame: Day 4 before and 0.5, 1, 2, 4 , 8, 12 , 14 h after treatment
1 secondary outcome
Venous thromboembolism diagnosed during the follow-up period
Time frame: Up to 6 weeks after surgery (day 42)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2018.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BIBR 1048 in people with Venous Thromboembolism, run by Boehringer Ingelheim.
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 4 inclusion and 18 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 31 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Rate of venous thrombolic events (time frame: Up to day 10 after hip surgery). The study lists 12 primary outcomes in all. 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 31 Aug 2018.