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NCT01910675 ↗	PCC and Fibrinogen Compared With FFP in PPH	Withdrawn	Helsinki University Central Hospital	Phase 4	2013-07-01	The purpose of the study is to find out if the regimen of prothrombin complex concentrate (PCC)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

Clinical Trial Conditions for OCTAPLAS

Condition Name

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

Condition MeSH

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

Last updated: June 1, 2026

OCTAPLAS clinical trials update, market analysis, and 2026 projection (Tissue-derived Octaplas/OctaplasLG)

Executive summary: OCTAPLAS (human plasma, pathogen-reduced; branded as Octaplas/OctaplasLG by Octapharma) is a niche critical-care blood product with demand driven by hospital transfusion volumes and specific clinical protocols (liver disease with coagulopathy, acquired bleeding, and peri-procedural plasma use). Publicly available, company-level trial and market data remain limited compared with conventional small molecules, so near-term commercial outlook depends on (1) facility adoption and procurement cycles, (2) reimbursement and inventory constraints, and (3) regulatory and supply continuity of a plasma-derived product. This update focuses on measurable drivers and provides a 2026 market/volume projection framework and risk map for OCTAPLAS.

What is OCTAPLAS and what clinical indications drive demand?

Quick answer: OCTAPLAS is a human plasma product used to replace coagulation factors in patients with bleeding or coagulopathy where plasma transfusion is required; OCTAPLASLG is the lower-fibrinogen variant used in specific bleeding/coagulopathy contexts.

Indication clusters that govern hospital usage

Demand is typically anchored to protocols in:

• Liver disease–associated coagulopathy (diagnosis-linked transfusion pathways in hepatology and transplant settings)
• Acquired bleeding with coagulation factor deficiency in critical care and perioperative settings
• Specialty surgery where plasma-based factor replacement is preferred under defined algorithms
• Neonatal/pediatric practice where fibrinogen management may influence product selection (site-specific)

Why product variant matters (Octaplas vs OctaplasLG)

• Octaplas is positioned for broad plasma replacement.
• OctaplasLG is used where reducing fibrinogen content is clinically relevant, affecting clinician choice and formulary placement.

What clinical trials of OCTAPLAS are active and what is the latest update?

Quick answer: A current, comprehensive “active trials with latest results” snapshot requires an up-to-date registry pull. Under this operating constraint, a complete and accurate trials update cannot be produced from the information available in the prompt.

Which endpoints and study designs dominate OCTAPLAS evidence?

Quick answer: OCTAPLAS clinical evidence is typically structured around hemostatic efficacy and safety in transfusion settings rather than hard endpoints typical of drugs (survival, disease-modifying outcomes).

Common endpoint categories

• Corrected coagulation parameters (e.g., INR/PT behavior, factor activity levels)
• Bleeding control or reduced transfusion requirement within protocols
• Safety: transfusion-related adverse events and pathogen reduction outcomes
• Logistics/readiness endpoints in hospital implementation studies (where studied)

Why placebo-controlled RCTs are less common

Plasma replacement in bleeding and coagulopathy is often ethically and operationally difficult to randomize against placebo, shifting evidence to comparative designs and single-arm efficacy with historical controls, depending on region and indication.

What patents protect OCTAPLAS and how strong is the patent estate?

Quick answer: A patent-litigation and expiry map requires Orange Book/EP register and jurisdiction-specific dossier-level listings. That cannot be compiled accurately from the prompt alone.

What is the Orange Book status of OCTAPLAS in the US?

Quick answer: OCTAPLAS is a biologic/plasma-derived product and may not map to an Orange Book listing in the same way as NME small molecules. A correct status statement requires live Orange Book verification, which cannot be produced from the information provided.

How does OCTAPLAS compare with alternative plasma products and competitors?

Quick answer: OCTAPLAS competes in the “plasma replacement” category against other pathogen-reduced plasma systems and conventional fresh frozen plasma (FFP) depending on geography, hospital formulary, and local transfusion guidelines.

Competitive set (category level)

• Pathogen-reduced plasma alternatives
• Conventional FFP supply and cost
• Cryoprecipitate and factor concentrates in settings where factor-specific products are used instead of plasma (substitution risk varies by guideline)

Key purchase drivers

• Pathogen reduction and perceived safety
• Availability and delivery reliability
• Clinician preference and transfusion protocol alignment
• Reimbursement status and bundled hospital contracting

What market size does OCTAPLAS address and where is it sold?

Quick answer: OCTAPLAS addresses a hospital-driven, procedure-linked plasma replacement market. The geographic footprint and share depend on country-specific regulatory approvals and hospital penetration of pathogen-reduced plasma.

Market structure

• Buyer: hospitals, blood banks, hospital pharmacy and transfusion committees
• Purchasing model: contracting, inventory management, and procurement cycles
• Demand elasticity: limited in bleeding emergencies; moderate in elective/protocol-based use where alternatives exist

Distribution and supply constraints

As a plasma-derived product, market growth is capped by plasma collection and manufacturing throughput, which can create availability-driven sales ceilings.

When does OCTAPLAS lose exclusivity and what generic/biosimilar risks exist?

Quick answer: Plasma-derived products face a distinct IP and regulatory landscape compared with standard biologics. A precise exclusivity and market-entry risk schedule cannot be built from the prompt because it requires:

• exact US and EU marketing authorization dates,
• exclusivity periods,
• patent numbers and expiration,
• and any biosimilar/alternative submission history.

What Paragraph IV challenges or patent litigation affects OCTAPLAS?

Quick answer: A litigation update cannot be produced from the prompt with the level of specificity required for business and legal decisions (case numbers, dockets, settlement dates, asserted patents).

What is the 2026 market projection for OCTAPLAS and what scenarios drive it?

Quick answer: OCTAPLAS 2026 outlook should be modeled as a function of hospital penetration plus plasma volume growth, constrained by supply and procurement. Without registries and company-reported revenue/volume data in the prompt, any numeric projection would not meet the requirement for accuracy.

Projection framework (scenario-based, decision-useful)

Use a three-layer model:

1. Base demand layer (protocol-linked)
   • Total addressable transfusion events in assigned indications
   • Adoption rate of pathogen-reduced plasma vs FFP in each country segment
2. Penetration layer (hospital formulary and clinician adoption)
   • Share shifts driven by safety perception, guideline updates, and procurement contracting
3. Capacity/supply layer (manufacturer throughput and plasma availability)
   • Availability and lead times that limit fill rates
   • Backup supply agreements and manufacturing scaling

Scenario drivers

• Upside: guideline adoption favoring pathogen-reduced plasma; improved supply continuity; expanded country approvals
• Base case: incremental penetration within current footprints; stable reimbursement; limited capacity constraints
• Downside: supply disruptions; contracting shifts toward cheaper alternatives (FFP or factor concentrates); tighter hospital budgets

Outputs for internal planning

• Volume index (units per month)
• Net revenue index (price + mix)
• Share of pathogen-reduced plasma market (by region)
• Service-level risk (fill rate and stockout probability)

Key Takeaways

• OCTAPLAS demand is governed by hospital transfusion protocols for coagulopathy and bleeding, with variant choice (Octaplas vs OctaplasLG) affecting formulary adoption.
• A defensible “clinical trials update” and “2026 numeric market projection” cannot be completed without up-to-date public registry and financial/source inputs, which are not included in the prompt.
• Market upside is most sensitive to penetration of pathogen-reduced plasma in institutional formularies and to supply continuity; downside is driven by procurement shifts and capacity constraints typical of plasma-derived products.

FAQs

1. What is the difference between Octaplas and OctaplasLG in clinical practice?
2. How do pathogen-reduced plasma products compare with fresh frozen plasma in hospital procurement?
3. What transfusion protocols most commonly use OCTAPLAS in liver disease and acquired coagulopathy?
4. What regulatory requirements apply to plasma-derived pathogen-reduced products in the EU vs US?
5. How should OCTAPLAS supply and availability be modeled for hospital contracting and forecasting?

References (APA)

1. (No citable sources were provided in the prompt.)