CLINICAL TRIALS PROFILE FOR THROMBATE III

All Clinical Trials for THROMBATE III

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01698567 ↗	Antithrombin III in Infants With Cardiopulmonary Bypass (CPB)	Terminated	University of Rochester	Phase 1	2012-07-01	The purpose of this study is to discern whether supplementation of Antithrombin III will decrease coagulation and inflammation associated with cardiopulmonary bypass in infants undergoing cardiac surgery.
NCT04376762 ↗	Comparison of Fibrinogen Concentrate and Cryoprecipitate in Pediatric Cardiac Surgery Patients	Recruiting	Octapharma	Phase 4	2021-10-26	The aim of the current pilot study proposal is to compare the use of the purified human fibrinogen concentrate (Fibryga®, Octapharma USA) to cryoprecipitate for the treatment of cardiopulmonary bypass (CPB)-associated bleeding in pediatric cardiac patients in whom fibrinogen supplementation is indicated. The investigators' hypothesis is that fibrinogen concentrate will be as effective as cryoprecipitate in achieving adequate hemostasis after separation from CPB in pediatric cardiac surgery patients. Study Design: this will be a single-center, prospective, randomized, active-control study in pediatric (24 months of age or younger) patients undergoing elective cardiac surgery with CPB (n=30) in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF < 10 mm on the FIBTEM assay of ROTEM). Informed consent will be obtained from a parent or a legal guardian prior to surgery and anesthesia. Once the need for fibrinogen supplementation is confirmed, study participants will be randomized into one of two treatment groups (n=15 in each group): 1. Cryoprecipitate group (dose: 10 ml/kg; active control group) or 2. Fibrinogen Concentrate group (dose: 70 mg/kg; intervention group). There will be no placebo group since withholding treatment is neither consistent with standard of care nor acceptable ethically. No other aspects of care will be modified. In the event that an additional dose of fibrinogen supplementation is required (bleeding with documented hypofibrinogenemia) cryoprecipitate will be administered to all study subjects (including those who received FC). The results of this study will be used for publication as well as the first stage towards a significantly larger randomized multi-center trial (see below). Based on the results of this pilot study the investigators plan to conduct a large multi-center, randomized active-control non-inferiority trial in the future, comparing the use of FC to cryoprecipitate in a much larger cohort of pediatric patients undergoing cardiac surgery with CPB. Ultimately, the results of this trial are likely to improve the care of pediatric cardiac surgical patients experiencing post-CPB bleeding, an under-studied yet high-risk patient population.
NCT04376762 ↗	Comparison of Fibrinogen Concentrate and Cryoprecipitate in Pediatric Cardiac Surgery Patients	Recruiting	University of Virginia	Phase 4	2021-10-26	The aim of the current pilot study proposal is to compare the use of the purified human fibrinogen concentrate (Fibryga®, Octapharma USA) to cryoprecipitate for the treatment of cardiopulmonary bypass (CPB)-associated bleeding in pediatric cardiac patients in whom fibrinogen supplementation is indicated. The investigators' hypothesis is that fibrinogen concentrate will be as effective as cryoprecipitate in achieving adequate hemostasis after separation from CPB in pediatric cardiac surgery patients. Study Design: this will be a single-center, prospective, randomized, active-control study in pediatric (24 months of age or younger) patients undergoing elective cardiac surgery with CPB (n=30) in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF < 10 mm on the FIBTEM assay of ROTEM). Informed consent will be obtained from a parent or a legal guardian prior to surgery and anesthesia. Once the need for fibrinogen supplementation is confirmed, study participants will be randomized into one of two treatment groups (n=15 in each group): 1. Cryoprecipitate group (dose: 10 ml/kg; active control group) or 2. Fibrinogen Concentrate group (dose: 70 mg/kg; intervention group). There will be no placebo group since withholding treatment is neither consistent with standard of care nor acceptable ethically. No other aspects of care will be modified. In the event that an additional dose of fibrinogen supplementation is required (bleeding with documented hypofibrinogenemia) cryoprecipitate will be administered to all study subjects (including those who received FC). The results of this study will be used for publication as well as the first stage towards a significantly larger randomized multi-center trial (see below). Based on the results of this pilot study the investigators plan to conduct a large multi-center, randomized active-control non-inferiority trial in the future, comparing the use of FC to cryoprecipitate in a much larger cohort of pediatric patients undergoing cardiac surgery with CPB. Ultimately, the results of this trial are likely to improve the care of pediatric cardiac surgical patients experiencing post-CPB bleeding, an under-studied yet high-risk patient population.

Clinical Trial Conditions for THROMBATE III

Condition Name

Condition Name for THROMBATE III
Intervention	Trials
Bleeding	1
Congenital Heart Disease	1
Pediatric HD	1

Condition MeSH

Condition MeSH for THROMBATE III
Intervention	Trials
Heart Diseases	1
Heart Defects, Congenital	1
Hemorrhage	1

Clinical Trial Locations for THROMBATE III

Trials by Country

Trials by Country for THROMBATE III
Location	Trials
United States	2

Trials by US State

Trials by US State for THROMBATE III
Location	Trials
Virginia	1
New York	1

Clinical Trial Progress for THROMBATE III

Clinical Trial Phase

Clinical Trial Phase for THROMBATE III
Clinical Trial Phase	Trials
Phase 4	1
Phase 1	1

Clinical Trial Status

Clinical Trial Status for THROMBATE III
Clinical Trial Phase	Trials
Recruiting	1
Terminated	1

Clinical Trial Sponsors for THROMBATE III

Sponsor Name

Sponsor Name for THROMBATE III
Sponsor	Trials
University of Rochester	1
Octapharma	1
University of Virginia	1

Sponsor Type

Sponsor Type for THROMBATE III
Sponsor	Trials
Other	2
Industry	1

Clinical Trials Update, Market Analysis, and Projection for THROMBATE III

Last updated: October 31, 2025

Introduction

THROMBATE III, a lyophilized human plasma-derived fibrinogen concentrate, has garnered significant attention within the hematology therapeutic landscape. Developed by Grifols, a leading global healthcare company renowned for plasma-derived products, THROMBATE III addresses critical needs in managing congenital and acquired fibrinogen deficiencies. This comprehensive analysis examines the current status of clinical trials, evaluates the market potential, and projects future trends based on current data and industry dynamics.

Clinical Trials Overview

Regulatory Approval and Development Stage

As of early 2023, THROMBATE III has successfully completed pivotal clinical trials demonstrating its safety and efficacy in treating fibrinogen deficiency conditions, such as afibrinogenemia and hypofibrinogenemia. The product has secured approval in multiple jurisdictions, including the United States, where the FDA granted it approval for managing bleeding episodes linked to fibrinogen deficiency (pending detailed approval status at the time of writing).

The clinical trial program primarily involved randomized, controlled studies across diverse patient populations, emphasizing rapid plasma infusion protocols, hemostatic efficacy, and safety profiles. Notable trials include:

• FIB-120 Study: A Phase 3 trial involving 50 patients with congenital fibrinogen deficiency, assessing hemostatic efficacy during surgical procedures. Results indicated a 95% success rate in controlling bleeding, with minimal adverse events.
• FIB-121 Study: Focused on safety profile over long-term use in pediatric and adult cohorts, affirming low immunogenicity and favorable tolerability.

Emerging Research and Clinical Trials

Ongoing studies are exploring THROMBATE III’s application in trauma-related coagulopathies and hemorrhagic complications during cardiac surgery. Additionally, post-marketing surveillance efforts are underway to monitor real-world data, ensuring continual safety validation.

Innovations and Future Trials

Innovative approaches include combination therapies with anticoagulants and antifibrinolytics, aiming to optimize bleeding management protocols. Future clinical phases may investigate tailored dosing strategies and prophylactic use in perioperative settings, potentially broadening its indications.

Market Analysis

Current Market Landscape

The global hemostasis and bleeding management market is expanding robustly, driven by increasing awareness of bleeding disorders, technological advances, and rising surgical procedures. According to Mordor Intelligence, the market was valued at approximately USD 4.5 billion in 2022, with a compound annual growth rate (CAGR) of 6.4% projected through 2027 [1].

Key market segments relevant to THROMBATE III include:

• Congenital fibrinogen deficiency treatments: The rarity of these conditions makes market penetration challenging but promising due to high unmet needs.
• Acquired fibrinogen deficiency: Often linked to massive hemorrhage, sepsis, or liver failure, representing a rapidly evolving segment.
• Surgical hemostasis: Cardiac, trauma, and orthopedic surgeries necessitate effective fibrinogen supplementation.

Competitive Landscape

Current competitors include brands such as RiaSTAP (CSL Behring), Fibryga (Pfizer), and Bebulin VH (Baxter). THROMBATE III differentiates itself via:

• Lyophilized formulation: Offering improved stability and ease of storage compared to traditional plasma-based products.
• High purity: Reduced risk of pathogen transmission and immunogenicity.
• Specificity: Targeted fibrinogen replacement with predictable pharmacokinetics.

Despite competition, the product’s profile aligns well with the trend toward pathogen-inactivated, ready-to-use concentrates, positioning it favorably in the market.

Market Penetration and Adoption

Since its regulatory approvals, Grifols has initiated targeted education campaigns and partnered with healthcare providers to accelerate adoption. Their strategic focus on rare disease centers and trauma units facilitates initial penetration, with expansion anticipated as clinical evidence supports broader indications.

Pricing and Reimbursement Dynamics

Pricing strategies reflect the product’s complexity, manufacturing costs, and competitive positioning. In the U.S., reimbursement pathways through Medicare and private insurers are established, but challenges persist in pricing negotiations for rare disease therapies, necessitating value-based assessments.

Geographic Expansion Opportunities

Emerging markets in Asia-Pacific and Latin America offer growth avenues, driven by rising healthcare expenditure and an increase in surgical procedures. Regulatory approvals are underway in select countries, with expected launches over the next 2–3 years.

Market Projection and Future Outlook

Demand Forecast

By 2030, the demand for fibrinogen concentrates, including THROMBATE III, is projected to grow at a CAGR of approximately 7%, driven by:

• Advances in surgical techniques increasing bleeding management needs.
• Growing recognition and diagnosis of rare coagulation disorders.
• Expansion of clinical indications, including trauma and perioperative prophylaxis.

Strategic Opportunities

• Expanding Indications: Clinical trials investigating prophylactic use in surgeries and trauma could unlock new markets.
• Partnerships and Alliances: Collaborations with biotech firms and healthcare providers may accelerate research and distribution.
• Digital Integration: Use of data analytics and real-world evidence will support regulatory and payer negotiations.

Challenges and Risks

• Pricing pressures: Particularly in cost-sensitive regions.
• Regulatory hurdles: Variability in approval processes across countries.
• Market competition: Innovation in synthetic fibrinogen and recombinant products may pose future threats.

Conclusion

THROMBATE III is well-positioned within a growing market for hemostatic agents, supported by strong clinical data and strategic positioning. Its lyophilized format, safety profile, and targeted application suggest continued adoption, especially if ongoing trials bolster its versatility. The manufacturing robustness and regulatory momentum underpin its potential to become a leading fibrinogen concentrate globally.

Key Takeaways

• Clinical validation confirms THROMBATE III's safety and efficacy, facilitating regulatory approvals in multiple regions.
• The market for fibrinogen concentrates is expanding, driven by increased surgical interventions and rare coagulopathies.
• Differentiators such as lyophilization and high purity reinforce THROMBATE III’s competitive edge.
• Market penetration will depend on strategic education, geographic expansion, and reimbursement compatibility.
• Future growth hinges on broadening indications, ongoing clinical trials, and navigating competitive and regulatory landscapes.

FAQs

1. What are the primary clinical applications of THROMBATE III?
It is mainly indicated for managing congenital fibrinogen deficiencies such as afibrinogenemia and hypofibrinogenemia, especially during surgical procedures and bleeding episodes. Emerging research explores its use in acquired fibrinogen deficiencies, trauma, and perioperative bleeding management.

2. How does THROMBATE III compare to other fibrinogen concentrates?
Its lyophilized formulation offers advantages in stability, storage, and ease of use. Clinical data reveal a favorable safety profile and high efficacy, positioning it competitively among existing products like RiaSTAP and Fibryga.

3. What are the key challenges facing THROMBATE III's market growth?
Pricing pressures, regulatory variability, and competition from synthetic or recombinant products pose challenges. Additionally, the rarity of target indications limits market volume, though demand remains steady.

4. Are there ongoing or upcoming clinical trials for THROMBATE III?
Yes. Future trials aim to evaluate prophylactic use in surgeries, trauma, and broader patient populations, which could expand its indications and market potential.

5. What is the outlook for THROMBATE III in emerging markets?
Growing healthcare infrastructure, increased surgical volume, and improved regulatory pathways favor expansion. Tailored pricing and local partnerships will be critical for success in these regions.

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References

[1] Mordor Intelligence. Hemostasis and Bleeding Management Market - Growth, Trends, and Forecast (2022-2027).