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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: Recruiting Phase 3 study of Acute Major Bleeding, sponsored by Octapharma.
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, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (66% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Binary outcome of effective (rating of excellent or good) or non-effective (rating of poor/none) in management of major bleeding events as assessed by the Independent Data Monitoring and Endpoint Adjudication Committee (IDMEAC) according to predefined criteria
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 |
What NCT04867837 shows while recruiting
NCT04867837 is an interventional study that assigns participants to a tested intervention. The registered 260 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (66% lower).
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 names 20 study sites across 9 states, led by 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.
Learn More About Clinical Trials
Similar trials for Acute Major Bleeding
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04867837's enrollment target sits among peer trials
260 1231st of 2000 higher than 767 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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