Acquired Coagulation Factor Deficiency Clinical Trial
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
| Verified date | February 2011 |
| Source | CSL Behring |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Austria: Federal Ministry for Health and Women |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 40 |
| Est. completion date | November 2006 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Key Inclusion Criteria: - Subjects on oral anticoagulation requiring rapid reversal due to acute bleeding or emergency surgery - INR > 2 at baseline Key Exclusion Criteria: - 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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Austria | Clinical Trials Registration Coordinator | Feldkirch | |
| Austria | Clinical Trials Registration Coordinator | Wien | |
| Germany | Clinical Trials Registration Coordinator | Halle/Saale | |
| Germany | Clinical Trials Registration Coordinator | Hannover | |
| Germany | Clinical Trials Registration Coordinator | Leipzig | |
| Germany | For information on sites in Europe, please contact our clinical research team in | Marburg | |
| Germany | Clinical Trials Registration Coordinator | München | |
| Hungary | Clinical Trials Registration Coordinator | Györ | |
| Hungary | Clinical Trials Registration Coordinator | Veszprém | |
| Israel | Clinical Trials Registration Coordinator | Haifa | |
| Lithuania | Clinical Trials Registration Coordinator | Kaunas | |
| Lithuania | Clinical Trials Registration Coordinator | Vilnius | |
| Netherlands | Clinical Trials Registration Coordinator | Amsterdam | |
| Poland | Clinical Trials Registration Coordinator | Warsaw | |
| Switzerland | Clinical Trials Registration Coordinator | Zuerich |
| Lead Sponsor | Collaborator |
|---|---|
| CSL Behring |
Austria, Germany, Hungary, Israel, Lithuania, Netherlands, Poland, Switzerland,
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 H — View Citation
Pabinger 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 antic — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Rapid reversal of anticoagulatory effect | |||
| Secondary | Clinical efficacy assessment (hemostatic effect) | |||
| Secondary | Increase of coagulation factors |