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Study of OCTAPLEX in Patients With Acute Major Bleeding on DOAC Therapy With Factor Xa Inhibitor

NCT04867837 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2025-11-12

No results posted yet for this 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

  • Acute Major Bleeding

Interventions

DRUG

Octaplex

Four-factor prothrombin complex concentrate (4F-PCC)

Sponsors & Collaborators

  • Octapharma

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-01
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Bosnia and Herzegovina
  • Croatia
  • France
  • Georgia
  • Germany
  • Italy
  • Poland
  • Spain
  • Turkey (Türkiye)
  • Ukraine
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04867837 on ClinicalTrials.gov