You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: May 23, 2025

CLINICAL TRIALS PROFILE FOR COAGULATION FACTOR VIIA (RECOMBINANT)


✉ Email this page to a colleague

« Back to Dashboard


Biosimilar Clinical Trials for coagulation factor viia (recombinant)

This table shows clinical trials for biosimilars. See the next table for all clinical trials
Trial ID Title Status Sponsor Phase Start Date Summary
NCT05668650 ↗ Double-blind Study to Evaluate the PK, Efficacy, Safety and Immunogenicity of MB12 Versus Keytruda® in Stage IV NSCLC Not yet recruiting Syneos Health Phase 3 2023-03-01 This is a randomized, multicenter, multinational, double-blind, and parallel-group study to evaluate the PK, efficacy, safety and immunogenicity of MB12 (proposed pembrolizumab biosimilar) versus Keytruda® in subjects with newly diagnosed stage IV non-squamous NSCLC. This study is planned to be conducted in approximately 48 sites in 7 countries, a total of 174 subjects will be enrolled. Eligible subjects will be randomized in a 1:1 ratio to receive MB12 or Keytruda® at a dose of 200 mg every 3 weeks. Subjects will be stratified by gender (male versus female) and ECOG status (0 versus 1) as both factors are considered to have the potential to influence PK properties of pembrolizumab to some extent. The study will consist of 2 periods defined as follows: - Main Study Period from Screening up to Cycle 6 included. - Extended Treatment Period from Cycle 7 up to Week 52 for those subjects who demonstrate clinical benefit from the treatment (complete response [CR], partial response [PR], and stable disease [SD]). They will continue treatment until disease progression, intolerance to the study drug, treatment discontinuation for other reason, or up to Week 52, whichever occurs first. A Data Safety Monitoring Board (DSMB) will assess the safety data periodically and will recommend to the sponsor whether to continue, modify, or stop the trial on the basis of safety considerations. After the first 10 subjects have received at least 2 cycles of treatment, the DSMB will review the accumulated safety data, and the first meeting will take place. Subsequent meetings will be performed as per the DSMB charter.
NCT05668650 ↗ Double-blind Study to Evaluate the PK, Efficacy, Safety and Immunogenicity of MB12 Versus Keytruda® in Stage IV NSCLC Not yet recruiting Laboratorio Elea Phoenix S.A. Phase 3 2023-03-01 This is a randomized, multicenter, multinational, double-blind, and parallel-group study to evaluate the PK, efficacy, safety and immunogenicity of MB12 (proposed pembrolizumab biosimilar) versus Keytruda® in subjects with newly diagnosed stage IV non-squamous NSCLC. This study is planned to be conducted in approximately 48 sites in 7 countries, a total of 174 subjects will be enrolled. Eligible subjects will be randomized in a 1:1 ratio to receive MB12 or Keytruda® at a dose of 200 mg every 3 weeks. Subjects will be stratified by gender (male versus female) and ECOG status (0 versus 1) as both factors are considered to have the potential to influence PK properties of pembrolizumab to some extent. The study will consist of 2 periods defined as follows: - Main Study Period from Screening up to Cycle 6 included. - Extended Treatment Period from Cycle 7 up to Week 52 for those subjects who demonstrate clinical benefit from the treatment (complete response [CR], partial response [PR], and stable disease [SD]). They will continue treatment until disease progression, intolerance to the study drug, treatment discontinuation for other reason, or up to Week 52, whichever occurs first. A Data Safety Monitoring Board (DSMB) will assess the safety data periodically and will recommend to the sponsor whether to continue, modify, or stop the trial on the basis of safety considerations. After the first 10 subjects have received at least 2 cycles of treatment, the DSMB will review the accumulated safety data, and the first meeting will take place. Subsequent meetings will be performed as per the DSMB charter.
>Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for coagulation factor viia (recombinant)

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000463 ↗ Post Coronary Artery Bypass Graft (CABG) Study Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 3 1987-04-01 To determine the relative effectiveness of moderate versus more aggressive lipid lowering, and of low dose anticoagulation versus placebo, in delaying saphenous vein coronary bypass graft atherosclerosis and preventing occlusion of saphenous grafts of patients with saphenous vein coronary bypass grafts placed 1 to 11 years previously.
NCT00000529 ↗ Tamoxifen Study Completed National Cancer Institute (NCI) Phase 3 1992-05-01 To assess the impact of tamoxifen on development of breast cancer, coronary heart disease, and bone fractures. The National Cancer Institute initiated the prevention trial under its National Surgical Adjuvant Breast and Bowel Project (NSABP). The National Heart, Lung, and Blood Institute provided support to obtain blood pressure and lipid measurements, and lipoprotein and selected coagulation factor measurements in a subsample.
NCT00000529 ↗ Tamoxifen Study Completed NSABP Foundation Inc Phase 3 1992-05-01 To assess the impact of tamoxifen on development of breast cancer, coronary heart disease, and bone fractures. The National Cancer Institute initiated the prevention trial under its National Surgical Adjuvant Breast and Bowel Project (NSABP). The National Heart, Lung, and Blood Institute provided support to obtain blood pressure and lipid measurements, and lipoprotein and selected coagulation factor measurements in a subsample.
NCT00000534 ↗ Calcium for Pre-Eclampsia Prevention (CPEP) Completed Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Phase 3 1991-03-01 To evaluate the efficacy of 2 grams per day of oral calcium supplementation in reducing the combined incidence of hypertensive disorders of pregnancy: pre-eclampsia, eclampsia, and the HELLP Syndrome (hypertension, thrombocytopenia, hemolysis, and abnormal liver function). The National Institute of Child Health and Human Development (NICHD) initiated the trial in 1991, with joint funding provided by the National Heart, Lung, and Blood Institute in fiscal years 1992, 1993, and 1995.
NCT00000534 ↗ Calcium for Pre-Eclampsia Prevention (CPEP) Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 3 1991-03-01 To evaluate the efficacy of 2 grams per day of oral calcium supplementation in reducing the combined incidence of hypertensive disorders of pregnancy: pre-eclampsia, eclampsia, and the HELLP Syndrome (hypertension, thrombocytopenia, hemolysis, and abnormal liver function). The National Institute of Child Health and Human Development (NICHD) initiated the trial in 1991, with joint funding provided by the National Heart, Lung, and Blood Institute in fiscal years 1992, 1993, and 1995.
NCT00000690 ↗ Single Dose Pharmacokinetics of Oral Dextran Sulfate (UA001) and Intravenous Dextran Sulfate in Healthy Volunteers Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 1 1969-12-31 To evaluate how the drug dextran sulfate (DS) is absorbed by the stomach and intestines when taken by mouth. To evaluate its effect on blood coagulation. DS has been reported to have anti-HIV activity. However, it is not known how much of the drug is absorbed into the bloodstream and can be used by the body when DS is taken by mouth.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for coagulation factor viia (recombinant)

Condition Name

Condition Name for coagulation factor viia (recombinant)
Intervention Trials
Healthy 30
Hemophilia A 25
COVID-19 24
Atrial Fibrillation 24
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

Condition MeSH for coagulation factor viia (recombinant)
Intervention Trials
Hemorrhage 89
COVID-19 57
Thrombosis 54
Hemophilia A 53
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for coagulation factor viia (recombinant)

Trials by Country

Trials by Country for coagulation factor viia (recombinant)
Location Trials
China 257
Canada 190
Italy 101
Germany 99
United Kingdom 99
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

Trials by US State for coagulation factor viia (recombinant)
Location Trials
California 69
Pennsylvania 61
Texas 60
New York 51
North Carolina 49
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Progress for coagulation factor viia (recombinant)

Clinical Trial Phase

Clinical Trial Phase for coagulation factor viia (recombinant)
Clinical Trial Phase Trials
Phase 4 254
Phase 3 198
Phase 2/Phase 3 49
[disabled in preview] 419
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

Clinical Trial Status for coagulation factor viia (recombinant)
Clinical Trial Phase Trials
Completed 524
Recruiting 196
Not yet recruiting 137
[disabled in preview] 257
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Sponsors for coagulation factor viia (recombinant)

Sponsor Name

Sponsor Name for coagulation factor viia (recombinant)
Sponsor Trials
Bayer 25
National Cancer Institute (NCI) 22
Boehringer Ingelheim 21
[disabled in preview] 53
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for coagulation factor viia (recombinant)
Sponsor Trials
Other 1451
Industry 430
NIH 65
[disabled in preview] 24
This preview shows a limited data set
Subscribe for full access, or try a Trial

Coagulation Factor VIIa (Recombinant): Clinical Trials, Market Analysis, and Projections

Introduction to Coagulation Factor VIIa (Recombinant)

Coagulation Factor VIIa (rFVIIa) is a recombinant human coagulation factor used primarily to treat bleeding episodes in patients with hemophilia A and B, especially those with inhibitors to factors VIII and IX. This protein is a crucial component of the extrinsic pathway of the coagulation cascade, facilitating the activation of factors X and IX to promote hemostasis[1][4][5].

Mechanism of Action

rFVIIa works by forming a complex with tissue factor, which activates factor X to factor Xa and factor IX to factor IXa. This activation leads to the conversion of prothrombin to thrombin, resulting in the formation of a hemostatic plug by converting fibrinogen to fibrin. This mechanism bypasses the need for factors VIII and IX, making it effective for patients with inhibitors to these factors[1][4][5].

Clinical Trials Update

Recent clinical trials have provided significant insights into the efficacy and safety of rFVIIa in treating bleeding disorders.

  • PERSEPT1 Study: This Phase 3, randomized, cross-over study evaluated the on-demand treatment of mild to moderate bleeding events in patients with hemophilia A or B who had inhibitors. The study involved 27 patients and showed that approximately 86% of moderate or mild bleeding episodes were successfully treated with rFVIIa (eptacog beta) at doses of 75 mcg/kg and 225 mcg/kg. All three severe bleeding episodes were successfully treated with the higher dose[4].

  • FDA Approval: In May 2020, the FDA approved Coagulation Factor VIIa (Recombinant)-jncw (SEVENFACT®) for the treatment of bleeding episodes in adults and adolescents aged > 12 years with hemophilia A or B with inhibitors. This approval was based on clinical studies demonstrating the efficacy of rFVIIa in managing bleeding events[3][4].

Market Analysis

The market for Coagulation Factor VIIa is experiencing significant growth driven by several key factors.

Market Size and Forecast

  • The global Coagulation Factor VIIa market was valued at $405 billion in 2023 and is projected to reach $768.26 billion by 2031, growing at a CAGR of 8.6% during the forecast period 2024-2031[2].

  • The human coagulation factor VII market, which includes rFVIIa, was valued at $2.6 billion in 2023 and is expected to reach $6.5 billion by 2033, growing at a CAGR of 9.4% from 2024 to 2033[5].

Market Segmentation

  • Product Type: The market is segmented into recombinant and plasma-derived Factor VIIa. Recombinant Factor VIIa, due to its safety profile and reduced risk of blood-borne pathogens, is gaining preference over plasma-derived products[2].

  • End-Users: Hospitals, specialty clinics, and home care settings are the primary end-users. Hospitals, with their advanced medical facilities and specialized healthcare personnel, are the largest consumers of Coagulation Factor VIIa[2].

  • Geographic Segmentation: The market is segmented into North America, Europe, Asia-Pacific, Middle East and Africa, and Latin America. North America, particularly the United States, is a leading region due to its advanced healthcare technologies and strong research and development capabilities. The Asia-Pacific region is also growing rapidly due to increasing incidences of bleeding disorders and improving healthcare access[2].

Key Drivers

  • Rise in Prevalence of Bleeding Disorders: The increasing prevalence of hemophilia and other bleeding disorders is driving the demand for effective hemostatic agents like rFVIIa[5].

  • Shift to Recombinant Products: The shift from plasma-derived to recombinant Factor VII products, which offer higher safety profiles, is significantly boosting the market[5].

  • Growing Geriatric Population: The need for more frequent surgeries and medical interventions in the geriatric population is increasing the demand for rFVIIa[5].

  • Off-Label Indications: The use of rFVIIa in managing uncontrolled bleeding in surgeries, trauma, and patients on anticoagulant therapy is expanding its clinical application and driving demand[5].

  • Regulatory Support: New and improved Factor VII products gaining approval for expanded therapeutic uses are further driving the market[5].

Market Projections

The future of the Coagulation Factor VIIa market looks promising, driven by several factors:

  • Increasing Demand: The rise in the number of patients with bleeding disorders and the need for effective treatments will continue to drive the market[5].

  • Advancements in Healthcare Infrastructure: The expansion of healthcare infrastructure, especially in emerging markets like Asia-Pacific and Latin America, will increase access to advanced therapies, including rFVIIa[5].

  • Strategic Collaborations: Collaborations between pharmaceutical companies, research institutions, and healthcare providers will foster innovation and expedite the development of new formulations and delivery mechanisms, further boosting the market[2].

Key Takeaways

  • Mechanism of Action: rFVIIa activates the coagulation cascade by forming a complex with tissue factor, activating factors X and IX, and leading to the formation of a hemostatic plug.

  • Clinical Trials: Recent trials, such as the PERSEPT1 study, have demonstrated the efficacy and safety of rFVIIa in treating bleeding episodes in patients with hemophilia A and B.

  • Market Growth: The Coagulation Factor VIIa market is projected to grow significantly, driven by the rise in prevalence of bleeding disorders, the shift to recombinant products, and the growing geriatric population.

  • Geographic Dynamics: North America and the Asia-Pacific region are key markets, with the latter showing rapid growth due to improving healthcare access and increasing incidences of bleeding disorders.

FAQs

What is the primary use of Coagulation Factor VIIa (Recombinant)?

Coagulation Factor VIIa (Recombinant) is primarily used to treat bleeding episodes in patients with hemophilia A and B, especially those with inhibitors to factors VIII and IX.

How does rFVIIa work?

rFVIIa forms a complex with tissue factor, activating factors X and IX, which leads to the conversion of prothrombin to thrombin and the formation of a hemostatic plug by converting fibrinogen to fibrin.

What are the key drivers of the Coagulation Factor VIIa market?

The key drivers include the rise in prevalence of bleeding disorders, the shift to recombinant products, the growing geriatric population, off-label indications, and regulatory support.

Which regions are expected to drive the growth of the Coagulation Factor VIIa market?

North America and the Asia-Pacific region are expected to be key drivers of the market, with the latter showing rapid growth due to improving healthcare access and increasing incidences of bleeding disorders.

What is the projected market size of the Coagulation Factor VIIa market by 2031?

The Coagulation Factor VIIa market is projected to reach $768.26 billion by 2031, growing at a CAGR of 8.6% during the forecast period 2024-2031.

Sources

  1. DrugBank: Coagulation factor VIIa Recombinant Human - DrugBank.
  2. Verified Market Research: Coagulation Factor VIIa Market Size, Scope, Growth, and Forecast.
  3. GlobeNewswire: Bleeding Disorder Treatment Market Size is expected to reach at USD 26,177 Million by 2030.
  4. VA Pharmacy Benefits Management Services: Factor VIIa (recombinant)-jncw (SEVENFACT®) Drug Monograph.
  5. Allied Market Research: Human Coagulation Factor VII Market Size, Share | Forecast 2033.
Last updated: 2025-01-17

More… ↓

⤷  Try for Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.