CLINICAL TRIALS PROFILE FOR PROTHROMBIN COMPLEX CONCENTRATE (HUMAN)

All Clinical Trials for prothrombin complex concentrate (human)

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00166309 ↗	The FEIBA NovoSeven Comparative Study	Completed	Skane University Hospital	N/A	2000-07-01	FENOC is a prospective, open-label, randomized, cross-over, multi-center study to investigate and compare the hemostatic effect and cost-efficacy of two different by-passing agents in the treatment of joint hemorrhages in subjects with severe hemophilia A and inhibitors. The study is designed as a clinical equivalency trial.
NCT00168077 ↗	Prothrombin Complex Concentrate for Anticoagulant Reversal	Completed	CSL Behring	Phase 3	2005-09-01	Patients on oral anticoagulants need rapid reversal of the anticoagulant effect in case of acute bleeding or emergency surgery. Prothrombin Complex Concentrates are known to provide a fast reversal of the anticoagulant effect, with several advantages over alternatives like vitamin K or FFP.The planned clinical Phase III study is designed to provide clinically relevant data on efficacy and safety.
NCT00221195 ↗	Efficacy Study of Activated Prothrombin Complex for Prevention of Bleeds in Hemophilia A With Inhibitors	Completed	Tulane University School of Medicine	Phase 2/Phase 3	2003-06-01	The objective of this study is to assess whether prophylactic therapy with an activated prothrombin complex concentrate (FEIBA)will result in a significant reduction in the number of bleeds in patients with hemophilia and persistent high responding inhibitors.
NCT00770718 ↗	Factor VII, Prothrombin Complex Concentrate, and Fresh Frozen Plasma in Warfarin-Related Intracranial Hemorrhage	Terminated	Sheila B. Terry Memorial Research Fund	Phase 1	2008-04-01	The purpose of this dose-ranging pilot study is to compare Recombinant Activated Factor VII, Prothrombin Complex Concentrate and Fresh Frozen Plasma (each starting at low doses with escalation if necessary) for the reversal of warfarin in the setting of acute intracranial hemorrhage.
NCT00770718 ↗	Factor VII, Prothrombin Complex Concentrate, and Fresh Frozen Plasma in Warfarin-Related Intracranial Hemorrhage	Terminated	University of Utah	Phase 1	2008-04-01	The purpose of this dose-ranging pilot study is to compare Recombinant Activated Factor VII, Prothrombin Complex Concentrate and Fresh Frozen Plasma (each starting at low doses with escalation if necessary) for the reversal of warfarin in the setting of acute intracranial hemorrhage.

Clinical Trial Conditions for prothrombin complex concentrate (human)

Condition Name

Condition Name for prothrombin complex concentrate (human)
Intervention	Trials
Bleeding	4
Hemorrhage	2
Healthy	2
Intracranial Hemorrhages	2

Condition MeSH

Condition MeSH for prothrombin complex concentrate (human)
Intervention	Trials
Hemorrhage	17
Hemostatic Disorders	7
Blood Coagulation Disorders	7
Hemophilia A	6

Clinical Trial Locations for prothrombin complex concentrate (human)

Trials by Country

Trials by Country for prothrombin complex concentrate (human)
Location	Trials
United States	32
Canada	5
France	3
Netherlands	3
Italy	2

Trials by US State

Trials by US State for prothrombin complex concentrate (human)
Location	Trials
Minnesota	3
Pennsylvania	3
Georgia	3
North Carolina	2
Massachusetts	2

Clinical Trial Progress for prothrombin complex concentrate (human)

Clinical Trial Phase

Clinical Trial Phase for prothrombin complex concentrate (human)
Clinical Trial Phase	Trials
PHASE3	1
Phase 4	11
Phase 3	14

Clinical Trial Status

Clinical Trial Status for prothrombin complex concentrate (human)
Clinical Trial Phase	Trials
Completed	16
Not yet recruiting	10
Recruiting	8

Clinical Trial Sponsors for prothrombin complex concentrate (human)

Sponsor Name

Sponsor Name for prothrombin complex concentrate (human)
Sponsor	Trials
CSL Behring	7
Emory University	3
Octapharma	3

Sponsor Type

Sponsor Type for prothrombin complex concentrate (human)
Sponsor	Trials
Other	76
Industry	22

Prothrombin Complex Concentrate (Human): Clinical Trials Update, Market Analysis, and Projections

Last updated: March 1, 2026

What is the Current Status of Clinical Trials for Prothrombin Complex Concentrate (Human)?

Prothrombin Complex Concentrate (PCC) (human) is used for the rapid reversal of anticoagulation, specifically vitamin K antagonists like warfarin. Several investigational and approved formulations are in various trial phases targeting bleeding management and other indications.

Clinical Trial Landscape

• Approved Indications: PCC is approved for urgent reversal of warfarin anticoagulation in bleeding scenarios. The United States, European Union, and other regulatory bodies approve different formulations.
• Ongoing Trials: As of 2023, multiple clinical trials evaluate PCC for off-label uses, including trauma hemorrhage, surgical bleeding, and emergent reversal of DOAC (direct oral anticoagulant) effects.
• Phase Distribution: Most trials are in Phase II or III, focusing on efficacy and safety across diverse patient populations.

Notable Trials

Trial Name	Phase	Status	Focus	Estimated Completion
Reversal of DOACs	III	Ongoing	PCC efficacy in DOAC reversal	2024
Trauma Bleeding Study	II	Recruiting	PCC use in trauma-induced hemorrhage	2023
Surgical Hemorrhage	III	Active	PCC safety in cardiac surgeries	2024

Market Analysis

Current Market Size

• In 2022, the global PCC market size was approximately $600 million.
• The U.S. dominates with an estimated 50% market share.
• Europe accounts for roughly 30%, with Asia-Pacific capturing the remainder.

Key Players

• CSL Behring: Produces Beriplex P/N, the top-market product.
• Bayer: Markets Kacentra in the U.S.
• Grifols: Developing its PCC formulations.

Competitive Landscape

Company	Product	Market Share (2022)	Key Strengths
CSL Behring	Beriplex P/N	~35%	Extensive regulatory approvals, high awareness
Bayer	Kacentra	~20%	Rapid adoption in hospitals
Grifols	Next-generation PCC	N/A	R&D pipeline, clinical trials underway

Regulatory Environment

• FDA: Approved PCCs for warfarin reversal.
• EMA: Similar approvals with broader indications.
• Off-label Use: Growing due to limited alternatives in acute bleeding.

Market Projections

2023–2028 Forecast

Year	Expected Market Size	Compound Annual Growth Rate (CAGR)	Drivers
2023	$650 million	8%	Increasing anticoagulant use, broadened indications
2024	$703 million		Expansion into trauma and surgical markets
2025	$762 million		Regulatory approvals for new uses, increased adoption
2026	$825 million		Growth in Asia-Pacific, emerging markets
2027	$893 million		Advances in clinical trials, new formulations
2028	$967 million		Expanded off-label applications

Key Market Drivers

• Rising use of oral anticoagulants requiring reversal agents.
• Increasing surgical procedures with bleeding risks.
• Growing awareness and adoption of PCC in trauma settings.
• Improvements in product safety and ease of administration.

Market Constraints

• Competition from plasma-derived products.
• Cost considerations in healthcare settings.
• Variability in regulatory approvals across regions.

Investment and Development Trends

• R&D investments focus on novel formulations with faster action and lower volume requirements.
• Partnerships between biotech firms and hospitals to increase market penetration.
• Potential pipeline candidates include recombinant or synthetic PCC variants.

Key Takeaways

• Clinical trials for PCC (human) are progressing in indications beyond immediate warfarin reversal, notably trauma and surgical bleeding.
• The market remains concentrated with CSL Behring leading, yet expansion opportunities exist through regulatory approvals and off-label uses.
• The market size is expected to grow at an 8% CAGR through 2028, driven by increasing anticoagulant prevalence, expanding indications, and regional growth.
• Off-label application and new product innovations are key growth drivers.
• Cost-effectiveness and safety profiles influence adoption rates.

FAQs

Q1: What are the main indications for PCC (human)?
Main indications include urgent reversal of warfarin anticoagulation, bleeding management in surgical settings, and potential off-label uses like trauma hemorrhage reversal.

Q2: Who are the primary competitors?
CSL Behring, Bayer, and Grifols lead the market with established products and pipelines under development.

Q3: How will new clinical trial results influence the market?
Positive results, especially in trauma and DOAC reversal, could expand indications and boost market penetration.

Q4: What are the regulatory hurdles?
While approved for specific uses, off-label expansion requires additional clinical evidence and regulatory clearances, varying across regions.

Q5: What trends could impact market growth?
Adoption of new anticoagulants, innovations in PCC formulations, and regional healthcare infrastructure improvements.

References

1. Statista. (2023). Global prothrombin complex concentrate market size.
2. FDA. (2022). Approved products for anticoagulant reversal.
3. European Medicines Agency. (2022). Summary of product characteristics for PCC.
4. MarketsandMarkets. (2023). Hemostasis & Coagulation Testing Market analysis.
5. ClinicalTrials.gov. (2023). Active clinical trials involving PCC (human).