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

Conditions

• Acute Major Bleeding

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Octaplex — DRUG
  Four-factor prothrombin complex concentrate (4F-PCC)

Study Details

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.

Key Dates

Start date

Sep 1, 2021

Status verified

Nov 2025

Primary completion

Dec 31, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

260 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Octaplex Low-dose
  Participants to receive 1 Octaplex infusion intravenously
• Experimental: Octaplex High-dose
  Participants to receive 1 Octaplex infusion intravenously

Primary Outcome Measure

Hemostatic efficacy [ Time Frame: Within 24 hours after the start of initial management ]

Central Contacts

• Sigurd Knaub, PhD
  +41554512141
  [email protected]

Locations (10)

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