CLINICAL TRIALS PROFILE FOR KCENTRA

All Clinical Trials for KCENTRA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02557672 ↗	PCC vs. FFP for Post Cardiopulmonary Bypass Coagulopathy and Bleeding	Enrolling by invitation	CSL Behring	Phase 4	2016-08-01	This will be the first prospective randomized controlled clinical trial directly comparing Prothrombin Complex Concentrate (PCC) Compared to Fresh Frozen Plasma (FFP) for post cardiopulmonary bypass microvascular bleeding and factor-mediated coagulopathy. Is there a difference in bleeding and transfusion requirements in patients received PCC versus FFP?
NCT02429453 ↗	FFP Versus PCC in Intracranial Hemorrhage	Withdrawn	University of Utah	N/A	2015-04-01	The goal of this study will be to determine whether PCC confers any benefits over FFP in traumatic and spontaneous intracranial hemorrhage with respect to multiple factors including time to correction, absolute international normalized ratio correction amount, cost, need for surgical intervention, and radiographic bleed expansion through a prospective, randomized control trial.
NCT02270918 ↗	Reversibility of Apixaban Anticoagulation With the Four Factor Prothrombin Complex Concentrate Kcentra	Completed	Bristol-Myers Squibb	Phase 1	2014-11-01	Apixaban is an anticoagulant (also known as blood thinner) approved by the Food and Drug Administration (FDA) for reducing the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation. It has no reliable method of reversal. Kcentra is an FDA approved drug derived from blood that is used as an antidote to treat people with bleeding associated with taking the well-known anticoagulant warfarin. This is a Phase I, placebo-controlled, single site, open-label, crossover trial to evaluate the reversibility apixaban anticoagulation with Kcentra.
NCT02270918 ↗	Reversibility of Apixaban Anticoagulation With the Four Factor Prothrombin Complex Concentrate Kcentra	Completed	CSL Behring	Phase 1	2014-11-01	Apixaban is an anticoagulant (also known as blood thinner) approved by the Food and Drug Administration (FDA) for reducing the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation. It has no reliable method of reversal. Kcentra is an FDA approved drug derived from blood that is used as an antidote to treat people with bleeding associated with taking the well-known anticoagulant warfarin. This is a Phase I, placebo-controlled, single site, open-label, crossover trial to evaluate the reversibility apixaban anticoagulation with Kcentra.
NCT02270918 ↗	Reversibility of Apixaban Anticoagulation With the Four Factor Prothrombin Complex Concentrate Kcentra	Completed	Thomas Jefferson University	Phase 1	2014-11-01	Apixaban is an anticoagulant (also known as blood thinner) approved by the Food and Drug Administration (FDA) for reducing the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation. It has no reliable method of reversal. Kcentra is an FDA approved drug derived from blood that is used as an antidote to treat people with bleeding associated with taking the well-known anticoagulant warfarin. This is a Phase I, placebo-controlled, single site, open-label, crossover trial to evaluate the reversibility apixaban anticoagulation with Kcentra.

Clinical Trial Conditions for KCENTRA

Condition Name

Condition Name for KCENTRA
Intervention	Trials
Hemorrhage	1
Intracranial Hemorrhage, Spontaneous	1
Intracranial Hemorrhage, Traumatic	1
Prothrombin Complex Concentrates	1

Condition MeSH

Condition MeSH for KCENTRA
Intervention	Trials
Hemorrhage	5
Wounds and Injuries	2
Thrombosis	1
Hemostatic Disorders	1

Clinical Trial Locations for KCENTRA

Trials by Country

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−

Trials by Country for KCENTRA
Location	Trials
United States	18
Georgia	1
Poland	1
Spain	1
Bulgaria	1

Trials by US State

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−

Trials by US State for KCENTRA
Location	Trials
Pennsylvania	3
Oregon	1
Maryland	1
Washington	1
Texas	1

Clinical Trial Progress for KCENTRA

Clinical Trial Phase

Clinical Trial Phase for KCENTRA
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	3
Phase 2	1

Clinical Trial Status

Clinical Trial Status for KCENTRA
Clinical Trial Phase	Trials
Completed	3
Recruiting	2
Not yet recruiting	1

Clinical Trial Sponsors for KCENTRA

Sponsor Name

Sponsor Name for KCENTRA
Sponsor	Trials
CSL Behring	4
Bristol-Myers Squibb	1
University of Maryland, College Park	1

Sponsor Type

Sponsor Type for KCENTRA
Sponsor	Trials
Other	9
Industry	8

KCENTRA: Clinical Trials, Market Analysis, and Projections

Introduction to KCENTRA

KCENTRA, a non-activated 4-factor prothrombin complex concentrate (PCC), is a crucial medication for the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist (VKA) therapy, such as warfarin, in adult patients with acute major bleeding. Here, we delve into the clinical trials, market analysis, and future projections for KCENTRA.

Clinical Trials and Efficacy

FDA Approval and Clinical Studies

KCENTRA received FDA approval in 2013 based on a pivotal clinical trial that compared its efficacy and safety to plasma, the traditional agent for warfarin reversal. This randomized, controlled Phase IIIb study enrolled 212 evaluable patients and demonstrated that KCENTRA met all efficacy and safety endpoints, including hemostatic efficacy and International Normalized Ratio (INR) reduction[3].

Key Findings

• KCENTRA achieved hemostatic efficacy in 72.4% of patients versus 65.4% for plasma at 24 hours from the start of infusion.
• INR reduction to ≤1.3 was achieved in 62.2% of patients receiving KCENTRA versus 9.6% receiving plasma at 30 minutes post-treatment.
• KCENTRA produced a rapid and sustained increase in plasma levels of major clotting factors (Factors II, VII, IX, X, proteins C and S), with INR correction significantly faster than with plasma (24 minutes versus nearly 3 hours)[3].

Comparative Studies

In another clinical trial, LEX-209, Balfaxar (another PCC) was compared head-to-head with KCENTRA. The study found that Balfaxar demonstrated effective hemostasis in 94.6% of patients versus 93.5% for KCENTRA, with similar safety profiles and INR reductions[1].

Safety Profile

Adverse Reactions

The most frequent adverse reactions observed in clinical trials for KCENTRA include headache, nausea/vomiting, arthralgia, and hypotension. Serious adverse reactions such as thromboembolic events (including stroke, pulmonary embolism, and deep vein thrombosis) have also been reported[3][4].

Thromboembolic Risks

Patients treated with KCENTRA, especially those with a history of prior thromboembolic events, are at a higher risk of thromboembolic complications. This risk must be carefully considered when resuming anticoagulation therapy after KCENTRA administration[4].

Market Analysis

Market Size and Growth

The global prothrombin complex concentrate (PCC) market, which includes KCENTRA, is projected to grow significantly. In 2019, the market size was valued at $695.3 million and is expected to reach $2,385.3 million by 2032, with a Compound Annual Growth Rate (CAGR) of 9.6%[2].

Segment Dominance

The 4-factor PCC segment, led by products like KCENTRA and Beriplex, dominates the market due to their clinically proven efficacy for urgent warfarin reversal and active government support to reduce warfarin-associated adverse events[2].

Regional Market

North America holds the highest market share, driven by the strategic presence of major manufacturers, FDA approvals for 4-factor PCCs, and increasing sales of KCENTRA. Europe and Asia Pacific are also expected to see significant growth due to factors such as the rising prescription rate of warfarin and government initiatives to improve healthcare affordability[2].

Market Projections

Future Growth Drivers

• Increasing Warfarin Prescriptions: The widespread use of warfarin as an anticoagulant, with over 30 million prescriptions annually, drives the demand for PCCs like KCENTRA for urgent reversal in cases of major bleeding[2].
• COVID-19 Impact: The pandemic has increased the demand for blood and plasma products, favoring the growth of the PCC market. Major manufacturers like CSL Behring and Grifols have reported increased productivity and revenue from plasma centers[2].
• Government Support: Active government measures to support the use of 4-factor PCCs and to develop innovative therapies for bleeding disorders are expected to boost the market[2].

Key Players

CSL Behring, the manufacturer of KCENTRA, holds a significant market share due to the high sales of KCENTRA, especially after its launch in Japan in 2017. Takeda Pharmaceuticals is another major player in the market, known for its strong sales force and expanding distribution network[2].

Key Takeaways

• Clinical Efficacy: KCENTRA has demonstrated superior hemostatic efficacy and rapid INR reduction compared to plasma in clinical trials.
• Safety Considerations: While KCENTRA has a favorable safety profile, it carries risks of thromboembolic events, particularly in patients with prior such events.
• Market Growth: The PCC market, driven by KCENTRA and other 4-factor PCCs, is expected to grow significantly due to increasing warfarin prescriptions, COVID-19 impacts, and government support.
• Regional Dominance: North America leads the market, with Europe and Asia Pacific showing promising growth potential.

FAQs

What is KCENTRA used for?

KCENTRA is used for the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist (VKA) therapy, such as warfarin, in adult patients with acute major bleeding.

How does KCENTRA compare to plasma in clinical trials?

KCENTRA has shown superior hemostatic efficacy and faster INR reduction compared to plasma in clinical trials, making it a preferred option for urgent warfarin reversal.

What are the common adverse reactions associated with KCENTRA?

The most frequent adverse reactions include headache, nausea/vomiting, arthralgia, and hypotension. Serious adverse reactions can include thromboembolic events.

Which regions are expected to drive the growth of the PCC market?

North America, Europe, and Asia Pacific are expected to drive the growth of the PCC market, with North America holding the highest market share.

What factors are driving the growth of the PCC market?

Increasing warfarin prescriptions, the COVID-19 pandemic's impact on plasma product demand, and active government support for 4-factor PCCs are key drivers of the market growth.

Sources

1. Octapharma's prothrombin complex concentrate, Balfaxar ... - Octapharma.
2. Prothrombin Complex Concentrate (PCC) Market Size, 2020-2032 - Fortune Business Insights.
3. CSL Behring Receives FDA Approval of Kcentra™ for Urgent ... - PR Newswire.
4. Prothrombin - CSL Behring Global - CSL Behring.
5. Prothrombin Complex Concentrates Market Share Report 2033 - Future Market Insights.