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Prothrombin Complex Concentrate

Clotting Medication for Major Bleeding

Phase 3
Recruiting
Research Sponsored by Octapharma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48-hour follow-up period
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial tests OCTAPLEX, a medication that helps blood to clot, in patients with severe bleeding who are on blood thinners. It works by providing essential proteins needed for blood clotting.

Who is the study for?
Adults (≥18 years) on oral factor Xa inhibitor therapy with acute major bleeding, defined as life-threatening or uncontrolled bleeding, symptomatic critical organ bleeding, or significant drop in hemoglobin. Participants must have anti-factor Xa activity ≥100 ng/mL and provide informed consent. Excluded are those with recent trauma, certain cardiovascular events, coagulation disorders, known hypersensitivity to plasma products, prior use of specific haemostatic agents for the current bleed or participation in another clinical trial within the last month.
What is being tested?
The study is testing OCTAPLEX's effectiveness and safety at two different doses for patients experiencing severe bleeding while on DOAC therapy with a factor Xa inhibitor. It's a phase 3 trial where participants are randomly assigned to receive either a low-dose or high-dose of OCTAPLEX in an adaptive design that allows modifications based on interim results.
What are the potential side effects?
Potential side effects may include reactions related to blood clotting since OCTAPLEX affects coagulation factors. There could also be allergic reactions due to its plasma-derived nature. Specific side effects will be monitored throughout the trial given its focus on safety.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48-hour follow-up period
This trial's timeline: 3 weeks for screening, Varies for treatment, and 48-hour follow-up period for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Hemostatic efficacy
Secondary study objectives
All-cause TEEs and All-cause Mortality
Blood pressure
Body Temperature
+4 more
Other study objectives
Change in Coagulation Parameters
Change in Hgb
Change in activated partial thromboplastin time (aPTT)
+10 more

Side effects data

From 2022 Phase 3 trial • 208 Patients • NCT02740335
48%
Procedural Pain
14%
Postoperative Wound Complications
12%
Asthenia
6%
Anaemia
6%
Nervous System Disorders
5%
Cardiac AEs
5%
Musculoskeletal and connective tissue disorders
5%
Dysuria
4%
Catheter Site Related Reaction
4%
Procedural Vomiting
4%
Metabolism and nutrition disorders
3%
Abdominal Pain
3%
Hyperthermia
2%
Abdominal Distension
2%
Suture Related Complication
2%
Respiratory, thoracic and mediastinal disorders
1%
Soft Tissue Haemorrhage
1%
Myocardial Ischaemia
1%
Mesenteric Haematoma
1%
Proctitis
1%
Angina Unstable
1%
Cardiac Failure Chronic
1%
Gastritis Erosive
1%
Death
1%
Multiple Organ Dysfunction Syndrome
1%
Orchitis
1%
Anastomotic Haemmorhage
1%
Failure to Anastomose
1%
Joint Dislocation
1%
Subdural Haemorrhage
1%
Cerebral Infarction
1%
Acute Respiratory Failure
1%
Pulmonary Embolism
1%
Pulmonary Oedema
1%
Dyschezia
1%
Pneumonia
1%
Shock
1%
Pyrexia
1%
Vascular Disorders
100%
80%
60%
40%
20%
0%
Study treatment Arm
Octaplex
Beriplex P/N (Kcentra)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Octaplex Low-doseExperimental Treatment1 Intervention
Participants to receive 1 Octaplex infusion intravenously
Group II: Octaplex High-doseExperimental Treatment1 Intervention
Participants to receive 1 Octaplex infusion intravenously
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Octaplex
2017
Completed Phase 3
~630

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Four-Factor Prothrombin Complex Concentrates (PCCs) such as OCTAPLEX provide essential clotting factors II, VII, IX, and X, which are crucial for the blood coagulation process. These factors work synergistically to form a stable blood clot, essential for stopping bleeding. This treatment is particularly important for patients with bleeding disorders or those on anticoagulant therapy, as their blood's ability to clot is compromised. By replenishing these clotting factors, PCCs help restore the coagulation pathway, effectively controlling and preventing excessive bleeding.
No activation of the common pathway of the coagulation cascade after a highly purified factor IX concentrate.Acquired hemophilia A as a cause of acute upper gastrointestinal hemorrhage.

Find a Location

Who is running the clinical trial?

OctapharmaLead Sponsor
85 Previous Clinical Trials
10,997 Total Patients Enrolled
2 Trials studying Bleeding
230 Patients Enrolled for Bleeding

Media Library

Octaplex (Prothrombin Complex Concentrate) Clinical Trial Eligibility Overview. Trial Name: NCT04867837 — Phase 3
Bleeding Research Study Groups: Octaplex Low-dose, Octaplex High-dose
Bleeding Clinical Trial 2023: Octaplex Highlights & Side Effects. Trial Name: NCT04867837 — Phase 3
Octaplex (Prothrombin Complex Concentrate) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04867837 — Phase 3
~7 spots leftby Dec 2024