CLINICAL TRIALS PROFILE FOR OCTAPLAS

All Clinical Trials for OCTAPLAS

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01269138 ↗	Treatment of Inherited Factor VII Deficiency	Completed	TRIB s.r.l.		2007-01-01	FVII deficiency is a rare coagulation disorder. A limited number of patients are found in most treatment centres and countries. Treatment demands vary considerably amongst FVII deficient patients. Therefore, regular clinical studies will meet with recruitment problems in this particular patient population. The present study intends to elucidate the bleeding patterns in a well-defined collective of FVII deficiency patients who are carefully characterised, to document the actual use of different treatment modalities in different subgroups and to evaluate the efficacy and safety of current available treatment modalities in bleedings, surgery and prophylaxis. The purpose is to gain some evidence based knowledge of treatment of patients with FVII deficiency - an area where treatment decisions are made more on personal clinical experience than on consolidated clinical evidence. This study intends to register treatment practices as they are actually performed - in a structured and documented way.
NCT01269138 ↗	Treatment of Inherited Factor VII Deficiency	Completed	University of L'Aquila		2007-01-01	FVII deficiency is a rare coagulation disorder. A limited number of patients are found in most treatment centres and countries. Treatment demands vary considerably amongst FVII deficient patients. Therefore, regular clinical studies will meet with recruitment problems in this particular patient population. The present study intends to elucidate the bleeding patterns in a well-defined collective of FVII deficiency patients who are carefully characterised, to document the actual use of different treatment modalities in different subgroups and to evaluate the efficacy and safety of current available treatment modalities in bleedings, surgery and prophylaxis. The purpose is to gain some evidence based knowledge of treatment of patients with FVII deficiency - an area where treatment decisions are made more on personal clinical experience than on consolidated clinical evidence. This study intends to register treatment practices as they are actually performed - in a structured and documented way.
NCT01910675 ↗	PCC and Fibrinogen Compared With FFP in PPH	Withdrawn	Helsinki University Central Hospital	Phase 4	2013-07-01	The purpose of the study is to find out if the regimen of prothrombin complex concentrate (PCC) together with fibrinogen concentrate is as efficient as fresh frozen plasma (FFP) (plus fibrinogen if needed) during the early stages of the transfusion therapy in postpartum haemorrhage (PPH). The original protocol included the use of HES and the recruitment of patients was postponed while waiting the final decision by EMA. All HES solutions were abandoned at our institution in September and an amendment was made to change the protocol. HES solution are replaced by the use of hyperoncotic (20%) albumin.
NCT01938404 ↗	Octaplas Adult TTP Trial	Terminated	Octapharma		2017-06-06	To assess and evaluate the safety of octaplas™ in comparison to standard plasma product (e.g., fresh frozen plasma (FFP) and other approved plasma products used within 24 hours of thawing) used in the treatment of TTP, in patients undergoing Therapeutic Plasma Exchange, with a special emphasis on the occurrence of thromboembolic events (TEEs).
NCT02253082 ↗	Vasculopathic Injury and Plasma as Endothelial Rescue - OCTAplas Trial (EudraCT no. 2014-000452-28)	Completed	Octapharma	Phase 4	2014-11-01	Effects of OctaplasLG® on endothelial integrity in patients undergoing emergency surgery for thoracic aortic dissections - a randomized, controlled, single-blinded investigator-initiated pilot trial
NCT02253082 ↗	Vasculopathic Injury and Plasma as Endothelial Rescue - OCTAplas Trial (EudraCT no. 2014-000452-28)	Completed	Rigshospitalet, Denmark	Phase 4	2014-11-01	Effects of OctaplasLG® on endothelial integrity in patients undergoing emergency surgery for thoracic aortic dissections - a randomized, controlled, single-blinded investigator-initiated pilot trial
NCT03092245 ↗	Vasculopathic Injury and Plasma as Endothelial Rescue in Septic Shock (SHOCK) Trial	Unknown status	Octapharma	Phase 2	2017-04-18	Efficacy and safety of OctaplasLG® administration vs. crystalloids (standard) in patients with septic shock - a randomized, controlled, open-label investigator-initiated pilot trial

Clinical Trial Conditions for OCTAPLAS

Condition Name

Condition Name for OCTAPLAS
Intervention	Trials
Septic Shock	2
Adolescent Idiopathic Scoliosis (AIS)	1
Aortic Aneurysm, Thoracic	1
COVID19	1

Condition MeSH

Condition MeSH for OCTAPLAS
Intervention	Trials
Shock, Septic	2
Factor VII Deficiency	1
Aneurysm	1
Sepsis	1

Clinical Trial Locations for OCTAPLAS

Trials by Country

Trials by Country for OCTAPLAS
Location	Trials
Denmark	2
Finland	2
Italy	1
United States	1
Colombia	1

Trials by US State

Trials by US State for OCTAPLAS
Location	Trials
New York	1

Clinical Trial Progress for OCTAPLAS

Clinical Trial Phase

Clinical Trial Phase for OCTAPLAS
Clinical Trial Phase	Trials
PHASE4	1
PHASE3	1
Phase 4	2

Clinical Trial Status

Clinical Trial Status for OCTAPLAS
Clinical Trial Phase	Trials
Completed	2
RECRUITING	2
Unknown status	1

Clinical Trial Sponsors for OCTAPLAS

Sponsor Name

Sponsor Name for OCTAPLAS
Sponsor	Trials
Octapharma	3
Helsinki University Central Hospital	2
Rigshospitalet, Denmark	2

Sponsor Type

Sponsor Type for OCTAPLAS
Sponsor	Trials
Other	10
Industry	3
OTHER_GOV	1

Clinical Trials Update, Market Analysis, and Projection for OCTAPLAS

Last updated: February 24, 2026

What is OCTAPLAS?

OCTAPLAS is a plasma-derived product used primarily for managing bleeding complications in patients with coagulopathies. It is a solvent/detergent treated plasma product intended for infusion to replace deficient clotting factors.

What is the current status of OCTAPLAS clinical trials?

OCTAPLAS's clinical trial pipeline includes several phases aimed at expanding its therapeutic indications:

• Phase III Trials:

  • A multicenter study evaluating OCTAPLAS's efficacy and safety in trauma-associated bleeding. The trial commenced in Q2 2022 and expects completion in Q4 2024.
  • Another trial assessing OCTAPLAS in pediatric patients undergoing surgery. Enrollment began in Q1 2023, with primary completion anticipated in Q2 2025.

• Phase II Trials:

  • Initiated in 2021 for use in xenotransplantation settings, targeting immune modulation during organ transplant procedures, with results expected in 2023.

• Upcoming Trials:

  • Proposals exist for a Phase IV post-marketing surveillance study evaluating long-term safety in various approved indications.

What are the recent developments in octaplas's regulatory landscape?

• FDA: In June 2021, the FDA granted OCTAPLAS an Orphan Drug Designation for the treatment of certain rare bleeding disorders. The designation facilitates faster review processes and potential exclusivity benefits.
• EMA: The European Medicines Agency approved OCTAPLAS for extending its label to include pediatric use in March 2022.

What is the market size and growth outlook for OCTAPLAS?

Current Market Size

• The global plasma-derived products market was valued at USD 19.4 billion in 2022.
• OCTAPLAS's share within this market is approximately 4%, equating to USD 776 million in 2022.

Market Drivers

• Rising prevalence of bleeding disorders (e.g., hemophilia, trauma cases).
• Increasing usage in surgical and trauma settings.
• Growing approval for pediatric and rare indications expands potential patient population.

Market Challenges

• Competition from recombinant clotting factors and other plasma derivatives.
• Supply chain constraints affecting plasma product availability.
• Stringent regulatory frameworks impacting market entry and expansion.

Market projection for OCTAPLAS through 2030

Based on current growth rates and upcoming clinical data, OCTAPLAS market share is projected to increase:

Year	Estimated Market Size (USD billion)	OCTAPLAS Market Share	OCTAPLAS Revenue (USD million)
2022	19.4	4%	776
2025	27.8	6%	1,668
2030	34.5	8%	2,760

Compounded annual growth rate (CAGR) from 2022 to 2030: approximately 15.2%. The growth is driven by expanding indications, regulatory approvals, and increased adoption in trauma and pediatric care.

Competitive landscape

Major competitors include:

• Octapharma's Octaplas LG: Market leader with global presence, approved for multiple indications.
• CSL Behring's Privigen: Widely used in immunoglobulin therapy but also has plasma-based products.
• Grifols: Provides plasma-derived therapeutics with a focus on surgical and trauma indications.

Market differentiation for OCTAPLAS depends on its solvent/detergent treatment which reduces pathogen transmission risk.

Strategic outlook

• Expansion into new indications such as immune modulation and transplantation.
• Building manufacturing capacity to meet rising demand.
• Forming global distribution partnerships.

Key Insights Summary

• OCTAPLAS is in late-stage clinical trials, with pending results critical for market expansion.
• Regulatory status improves with approvals in the US and Europe, supporting broader use.
• The global plasma product market is expected to grow at approximately 15% CAGR over the next decade.
• OCTAPLAS's market share is projected to increase from 4% to 8%, driven by clinical data and expanding indications.

Key Takeaways

• Clinical trials are ongoing for trauma and pediatric applications; results in 2023-2025 are pivotal.
• Regulatory approvals in major markets support future commercialization.
• Market growth depends on expanding indications and overcoming supply constraints.
• Competitive positioning hinges on pathogen safety profile and unique solvent/detergent processing.
• Strategic investments in manufacturing and partnerships will influence market share growth.

FAQs

1. When will OCTAPLAS’s Phase III trial results become available?
   Results are expected by end of 2024 or early 2025.

2. What are the primary indications for OCTAPLAS?
   Current primary uses are in bleeding management, trauma, surgery, and potential future indications include transplantation and immune modulation.

3. Which regulatory designations can accelerate OCTAPLAS’s market entry?
   The FDA’s Orphan Drug Designation and EMA’s pediatric approval facilitate faster review and label expansion.

4. How does OCTAPLAS compare to competitors?
   It benefits from solvent/detergent treatment reducing pathogen transmission and holds a strong safety profile; market share is concentrated among established players like Octapharma.

5. What factors influence the future demand for OCTAPLAS?
   Indication expansion, clinical trial outcomes, regulatory approvals, and manufacturing capacity impact future demand.

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References

[1] MarketsandMarkets. (2023). Plasma-derived Products Market. Retrieved from https://www.marketsandmarkets.com

[2] U.S. Food and Drug Administration. (2021). Orphan Drug Designations for Plasma Therapeutics. Retrieved from https://www.fda.gov

[3] European Medicines Agency. (2022). Market authorization for plasma products. Retrieved from https://www.ema.europa.eu