Acquired Coagulation Factor DeficiencyPhase 3NCT00168077
Prothrombin Complex Concentrate for Anticoagulant Reversal
A Phase 3 study testing Prothrombin Complex Concentrate in people with Acquired Coagulation Factor Deficiency, run by CSL Behring at 15 sites in 8 countries.
Trial summary
Patients on oral anticoagulants need rapid reversal of the anticoagulant effect in case of acute bleeding or emergency surgery. Prothrombin Complex Concentrates are known to provide a fast reversal of the anticoagulant effect, with several advantages over alternatives like vitamin K or FFP.The planned clinical Phase… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acquired Coagulation Factor Deficiency
- What is being tested?
- Prothrombin Complex Concentrate
- How many people
- 40 participants
- Where
- 15 sitesin 8 countries
- Study dates
- Sep 2005to Nov 2006
- Phase
- Phase 3
- 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
- Subjects on oral anticoagulation requiring rapid reversal due to acute bleeding or emergency surgery
- INR > 2 at baseline
Who cannot join
- Acute thromboembolic event
- Treatment with any other investigational drug in the last 30 days before study entry
- Less than 2 weeks of stable oral anticoagulation
Trial locations and contacts
15 sites in 8 countries.
15 sites in 8 countries
Germany5 sites
Clinical Trials Registration Coordinator
Halle, 06112
Clinical Trials Registration Coordinator
Hanover, 30623
Clinical Trials Registration Coordinator
Leipzig, 04129
For information on sites in Europe, please contact our clinical research team in
Marburg, 35002
Clinical Trials Registration Coordinator
München, 81377
Austria2 sites
Clinical Trials Registration Coordinator
Feldkirch, 6800
Clinical Trials Registration Coordinator
Vienna, 1090
Hungary2 sites
Clinical Trials Registration Coordinator
Győr, 9023
Clinical Trials Registration Coordinator
Veszprém, 8220
Lithuania2 sites
Clinical Trials Registration Coordinator
Kaunas, 500009
Clinical Trials Registration Coordinator
Vilnius, 08661
Netherlands1 site
Clinical Trials Registration Coordinator
Amsterdam, 1105 AZ
About this study
Official title: Efficacy and Tolerance of BERIPLEX® P/N in Subjects With Acquired Deficiency of Coagulation Factors II, VII, IX and X Due to Oral Anticoagulation
Patients on oral anticoagulants need rapid reversal of the anticoagulant effect in case of acute bleeding or emergency surgery. Prothrombin Complex Concentrates are known to provide a fast reversal of the anticoagulant effect, with several advantages over alternatives like vitamin K or FFP.The planned clinical Phase III study is designed to provide clinically relevant data on efficacy and safety.
- Conditions
- Acquired Coagulation Factor Deficiency
- Being tested
- Prothrombin Complex Concentrate
- Keywords
- Prothrombin Complex Concentrate, Anticoagulant reversal
- Medical subject headings
- Hemophilia B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prothrombin Complex ConcentrateDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Rapid reversal of anticoagulatory effect
Secondary outcomes (2)
Clinical efficacy assessment (hemostatic effect)
Increase of coagulation factors
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startSep 2005
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acquired Coagulation Factor DeficiencyStudies of the same condition, open and under way.
- More trials run by CSL BehringThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- CSL Behring
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Ingrid Pabinger-Fasching, Prof., Principal investigator, Universitätsklinik für Innere Medizin I der Stadt Wien
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00168077
- Sponsor's protocol ID
- BE1116_3001
- Status last verified
- Feb 2011
- First submitted
- 12 Sep 2005
- Last updated
- 11 Feb 2011
- Results posted
- No
Publications
Pabinger I, Brenner B, Kalina U, Knaub S, Nagy A, Ostermann H; Beriplex P/N Anticoagulation Reversal Study Group. Prothrombin complex concentrate (Beriplex P/N) for emergency anticoagulation reversal: a prospective multinational clinical trial. J Thromb Haemost. 2008 Apr;6(4):622-31. doi: 10.1111/j.1538-7836.2008.02904.x. Epub 2008 Jan 15.
PubMed 18208533Pabinger I, Tiede A, Kalina U, Knaub S, Germann R, Ostermann H; Beriplex P/N Anticoagulation Reversal Study Group. Impact of infusion speed on the safety and effectiveness of prothrombin complex concentrate: a prospective clinical trial of emergency anticoagulation reversal. Ann Hematol. 2010 Mar;89(3):309-16. doi: 10.1007/s00277-009-0830-7. Epub 2009 Sep 29.
PubMed 19787352
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Tolerance of BERIPLEX® P/N in Subjects With Acquired Deficiency of Coagulation Factors II, VII, IX and X Due to Oral Anticoagulation
- ClinicalTrials.gov ID
- NCT00168077
- Acronym / sponsor ID
- BE1116_3001
- Conditions
- Acquired Coagulation Factor Deficiency
- Keywords
- Prothrombin Complex Concentrate, Anticoagulant reversal
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- CSL BehringIndustry (pharma, biotech, devices)
- Study start
- Sep 2005
- Study completion
- Nov 2006 (actual)
- First posted
- 14 Sep 2005 (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.
Patients on oral anticoagulants need rapid reversal of the anticoagulant effect in case of acute bleeding or emergency surgery. Prothrombin Complex Concentrates are known to provide a fast reversal of the anticoagulant effect, with several advantages over alternatives like vitamin K or FFP.The planned clinical Phase III study is designed to provide clinically relevant data on efficacy and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects on oral anticoagulation requiring rapid reversal due to acute bleeding or emergency surgery
- INR > 2 at baseline
Key exclusion criteria (3 listed)
- Acute thromboembolic event
- Treatment with any other investigational drug in the last 30 days before study entry
- Less than 2 weeks of stable oral anticoagulation
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 |
|---|---|---|
| Prothrombin Complex Concentrate | Drug | – |
Primary outcome
Rapid reversal of anticoagulatory effect
2 secondary outcomes
Clinical efficacy assessment (hemostatic effect)
Increase of coagulation factors
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 11 Feb 2011.
- Results publication: PubMed 18208533Pabinger I, Brenner B, Kalina U, Knaub S, Nagy A, Ostermann H; Beriplex P/N Anticoagulation Reversal Study Group. Prothrombin complex concentrate (Beriplex P/N) for emergency anticoagulation reversal: a prospective multinational clinical trial. J Thromb Haemost. 2008 Apr;6(4):622-31. doi: 10.1111/j.1538-7836.2008.02904.x. Epub 2008 Jan 15.
- Results publication: PubMed 19787352Pabinger I, Tiede A, Kalina U, Knaub S, Germann R, Ostermann H; Beriplex P/N Anticoagulation Reversal Study Group. Impact of infusion speed on the safety and effectiveness of prothrombin complex concentrate: a prospective clinical trial of emergency anticoagulation reversal. Ann Hematol. 2010 Mar;89(3):309-16. doi: 10.1007/s00277-009-0830-7. Epub 2009 Sep 29.
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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.
Ingrid Pabinger-Fasching, Prof. principal investigator
Universitätsklinik für Innere Medizin I der Stadt Wien
15 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Prothrombin Complex Concentrate in people with Acquired Coagulation Factor Deficiency, run by CSL Behring at 15 sites in 8 countries.
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 2 inclusion and 3 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 11 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Germany, Austria, Hungary, Lithuania, Israel and 3 more countries. 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?
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?
Rapid reversal of anticoagulatory effect. 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 NCT00168077, 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 11 Feb 2011.