What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

Common side effects of treatments like Four-Factor Prothrombin Complex Concentrate (PCC) include thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism), allergic reactions, and disseminated intravascular coagulation (DIC). There is also a rare risk of viral transmission due to the blood-derived nature of these products. Close monitoring is essential to manage and mitigate these risks.

What prior FDA approvals exist?

The FDA has approved several treatments for bleeding disorders that provide essential clotting factors. Four-factor prothrombin complex concentrates (PCCs), such as Kcentra, are approved for urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist therapy in patients with acute major bleeding. These PCCs provide clotting factors II, VII, IX, and X, similar to OCTAPLEX. Additionally, recombinant factor IX products like BeneFIX and Rixubis are approved for hemophilia B, while recombinant factor VIII products are used for hemophilia A. These treatments are crucial for managing bleeding episodes and ensuring proper blood coagulation in affected patients.

What other types of research exist?

Promising novel alternatives to OCTAPLEX for bleeding patients include: 1) Concizumab, an anti-TFPI monoclonal antibody, which has shown efficacy in hemophilia A and B with inhibitors. 2) Fitusiran, an investigational siRNA therapeutic targeting antithrombin, which has demonstrated potential in reducing bleeding episodes in hemophilia A and B. 3) Recombinant factor IX Fc fusion protein (rFIXFc) and glycoPEGylated recombinant factor IX, both of which offer extended half-life and improved pharmacokinetics for hemophilia B patients.

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 48-hour follow-up period

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

Anaemia

Nervous System Disorders

Cardiac AEs

Musculoskeletal and connective tissue disorders

Dysuria

Catheter Site Related Reaction

Procedural Vomiting

Metabolism and nutrition disorders

Abdominal Pain

Hyperthermia

Abdominal Distension

Suture Related Complication

Respiratory, thoracic and mediastinal disorders

Soft Tissue Haemorrhage

Myocardial Ischaemia

Mesenteric Haematoma

Proctitis

Angina Unstable

Cardiac Failure Chronic

Gastritis Erosive

Death

Multiple Organ Dysfunction Syndrome

Orchitis

Anastomotic Haemmorhage

Failure to Anastomose

Joint Dislocation

Subdural Haemorrhage

Cerebral Infarction

Acute Respiratory Failure

Pulmonary Embolism

Pulmonary Oedema

Dyschezia

Pneumonia

Shock

Pyrexia

Vascular Disorders

100%

80%

60%

40%

20%

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

Do I qualify?Apply below to find out

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.