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NCT04867837 · ClinicalTrials.gov registry record · Phase 3
Study of OCTAPLEX in Patients With Acute Major Bleeding on DOAC Therapy With Factor Xa Inhibitor
A Phase 3 study of Acute Major Bleeding, sponsored by Octapharma.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 260
- Enrollment target
- 20
- Study locations
NCT04867837 is a Phase 3 study of Acute Major Bleeding that is actively recruiting participants, run by Octapharma. The registered enrollment target is 260 participants. The trial reports 20 study locations across 9 states.
The verdict
NCT04867837, a Phase 3 study of Acute Major Bleeding, is actively recruiting participants, sponsored by Octapharma.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 260 participants
- Enrollment target
- 20
- Study locations
Study 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 Studied
Interventions
- DRUG Octaplex
Study Locations (20)
Other
- Klinikum Klagenfurt am Wörthersee Anästhesiologie und Intensivmedizin - Klagenfurt
- University Clinical Centre of the Republic of Srpska - Banja Luka
- Univeristy Clinical Hospital Mostar - Mostar
- Clinical Center University of Sarajevo - Sarajevo
- University Clinical Center Tuzla - Tuzla
- Clinical Hospital Dubrava - Zagreb
- University Hospital Centre Zagreb - Zagreb
- Centre Hospitalier Universitaire Francois Mitterand - Dijon
- Pineo Medical Ecosystem - Tbilisi
- Tbilisi Institute of Medicine - Tbilisi
Florida
- The University of Florida - Gainesville
- St. Mary's Medical Center - West Palm Beach
Texas
- Ascension Seton Medical Center Austin - Austin
- Dell Seton Medical Center at the University of Texas - Austin
California
- Harbor-UCLA Medical Center - Torrance
Massachusetts
- Beth Israel Deaconess Medical Center - Boston
Minnesota
- Hennepin County Medical Center - Minneapolis
Mississippi
- University of Mississippi Medical Center - Jackson
Oklahoma
- OU Health - University of Oklahoma Medical Center - Oklahoma City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 260 participants |
| Start Date | 2021-09-01 |
| Est. Completion | 2026-12 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04867837
The ClinicalTrials.gov registry entry for NCT04867837 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 260 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Octapharma, which has 43 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Acute Major Bleeding appearing as the primary indexed condition, and to 1 intervention - of which Octaplex is the first listed.
NCT04867837 reports 20 study locations spanning 9 distinct geographic areas - top geographies include Other, Florida, Texas.
Frequently Asked Questions
What is clinical trial NCT04867837 about?
NCT04867837 is a clinical study titled "Study of OCTAPLEX in Patients With Acute Major Bleeding on DOAC Therapy With Factor Xa Inhibitor". 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 fac...
What is the current status of trial NCT04867837?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 260 participants. The study started on 2021-09-01. Estimated completion is 2026-12.
What conditions does trial NCT04867837 study?
This clinical trial studies the following conditions: Acute Major Bleeding.
What interventions are being tested in trial NCT04867837?
The interventions under investigation include: Octaplex (DRUG).
Who is sponsoring clinical trial NCT04867837?
This trial is sponsored by Octapharma, which has 43 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04867837 being conducted?
This trial has 20 study locations across California, Florida, Massachusetts, Minnesota, Mississippi. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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