Trials / Recruiting
RecruitingNCT04867837
Study of OCTAPLEX in Patients With Acute Major Bleeding on DOAC Therapy With Factor Xa Inhibitor
Study of Four-factor Prothrombin Complex Concentrate, OCTAPLEX, in Patients With Acute Major Bleeding on Direct Oral Anticoagulant (DOAC) Therapy With Factor Xa Inhibitor
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 260 (estimated)
- Sponsor
- Octapharma · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a multicentre, prospective, randomised, double-blinded, group-sequential, parallel-group, adaptive design, phase 3 study to demonstrate the haemostatic efficacy and safety of four-factor prothrombin complex concentrate, OCTAPLEX, in patients with acute major bleeding on DOAC therapy with factor Xa inhibitor. Patients will be randomised 1:1 to either of two study groups: low-dose vs. high-dose OCTAPLEX.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Octaplex | Four-factor prothrombin complex concentrate (4F-PCC) |
Timeline
- Start date
- 2021-09-01
- Primary completion
- 2026-12-01
- Completion
- 2026-12-01
- First posted
- 2021-04-30
- Last updated
- 2025-11-12
Locations
63 sites across 13 countries: United States, Austria, Bosnia and Herzegovina, Croatia, France, Georgia, Germany, Italy, Poland, Spain, Turkey (Türkiye), Ukraine, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04867837. Inclusion in this directory is not an endorsement.