CClinicalTrials.gg
Sign In
CompletedNCT02170701Updated Aug 31, 2018

BIBR 1048 in the Prevention of Venous Thromboembolism in Patients Undergoing Primary Elective Total Hip Replacement Surgery

A Phase 2 interventional study of BIBR 1048 in Venous Thromboembolism, sponsored by Boehringer Ingelheim. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-08-31.

Sponsored by Boehringer Ingelheim · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
289
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.
02

Conditions studied

  • Venous Thromboembolism
03

In context

Thromboembolism

818 studies on the registry are indexed under Thromboembolism; 98 are open to participants now.

This study's enrollment of 289 is above the median of 196 across 436 interventional studies indexed under Thromboembolism.

Browse Thromboembolism studies →

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
289 participants (actual)

Study arms

  • Experimental
    BIBR 1048

    Ascending doses (in mg) given twice daily

    Drug: BIBR 1048

Interventions

  • DrugBIBR 1048

    Ascending doses (in mg) given twice daily

06

What researchers measure

Primary outcomes

  1. Rate of venous thrombolic events

    Time frame: Up to day 10 after hip surgery

  2. 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)

  3. 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)

  4. 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)

  5. Rate of major bleeding events during treatment phase

    Time frame: Start of treatment (day 0) until end of treatment (up to day 10)

  6. Cpre,ss (predose plasma concentrations at steady state)

    Time frame: baseline and predose from day 1 to last treatment day

  7. Cmax,ss (maximum plasma concentration at steady state (day 4))

    Time frame: Day 4

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

Secondary outcomes

  1. Venous thromboembolism diagnosed during the follow-up period

    Time frame: Up to 6 weeks after surgery (day 42)

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 31, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02170701
Lead sponsor
Boehringer Ingelheim
Responsible party
Sponsor
First posted
Jun 23, 2014
Start date
Oct 2000
Primary completion
Jun 2001
Last update
Aug 31, 2018
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Thromboembolism→

Other studies from this sponsor

Boehringer Ingelheim

Start the discussion