Recruiting

BALFAXAR vs. KCENTRA

Sponsor:

Octapharma

Code:

NCT06429787

Conditions

Vitamin K-Dependent Coagulation Defect

Significant Bleeding Risk

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Balfaxar

Kcentra

Study Details

Brief summary:

Post marketing observational study on safety of BALFAXAR vs. KCENTRA for Reversal of Vitamin K Antagonist Induced Anticoagulation in Adults Undergoing Urgent Surgery or Invasive Procedure

Conditions

Vitamin K-Dependent Coagulation Defect

Significant Bleeding Risk

Study ID

NCT06429787

Start date

Feb 14, 2025

Status verified date

Aug, 2026

Completion date

Jun 30, 2032

Anticipated

Primary completion date

Dec 31, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Subjects at least 18 years of age.
2. Subjects on VKA treatment.
3. Received 4F-PCC agent, BALFAXAR or Kcentra, for urgent reversal of within 48 hours prior to urgent surgery or invasive procedure.

Exclusion Criteria:

1. History of TEE within 90 days before receipt of VKA reversal therapy.
2. Subjects treated with VKA reversal therapy and not undergoing urgent invasive procedure.

Study Design

Enrollment

3574 participants

Anticipated

Interventions and Outcome Measures

Arms

BALFAXAR® (500 IU)

BALFAXAR will be administered by intravenous (IV) infusion at a rate of 0.12 mL/kg/min (\~3 units/kg/min), up to a maximum rate of 8.4 mL/min (\~210 units/min). Dosing is individualized based on the patient's baseline International Normalized Ratio (INR) value and body weight

Kcentra® (500 IU)

KCENTRA will be administered by intravenous infusion at of 0.12 mL/kg/min (\~3 units/kg/min) up to a maximum rate of 8.4 mL/min (\~210 units/min). Dosing is individualized based on the patient's baseline International Normalized Ratio (INR) value and body weight.

Interventions

Balfaxar

BALFAXAR (prothrombin complex concentrate, human-lans) is a blood coagulation factor replacement product indicated for the urgent reversal of acquired coagulation factor deficiency induced by Vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with need for an urgent surgery/invasive procedure

Kcentra

KCENTRA, Prothrombin Complex Concentrate (Human), is a blood coagulation factor replacement product indicated for the urgent reversal of acquired coagulation factor deficiency induced by Vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with:

  • acute major bleeding or
  • need for an urgent surgery/invasive procedure

Primary outcome measure

  • TEEs within 45 days following VKA reversal treatment [ Time Frame: 45 days ]

Central Contacts and Locations

Central contacts

Theresa Conklin

8663371868p.murphy@crmg-usa.com

Locations

Octapharma Research Site

Recruiting

Boston, Massachusetts, United States, 02215

More Information

Sponsor

Octapharma

Last update posted

Aug 6, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Octapharma on 2026-08-06.