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Last Updated: March 29, 2024

CLINICAL TRIALS PROFILE FOR COAGULATION FACTOR IX RECOMBINANT HUMAN


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Biosimilar Clinical Trials for coagulation factor ix recombinant human

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 ix recombinant human

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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for coagulation factor ix recombinant human

Condition Name

Condition Name for coagulation factor ix recombinant human
Intervention Trials
Healthy 30
Hemophilia A 25
Atrial Fibrillation 24
COVID-19 24
[disabled in preview] 0
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Condition MeSH

Condition MeSH for coagulation factor ix recombinant human
Intervention Trials
Hemorrhage 87
COVID-19 57
Thrombosis 53
Hemophilia A 50
[disabled in preview] 0
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Clinical Trial Locations for coagulation factor ix recombinant human

Trials by Country

Trials by Country for coagulation factor ix recombinant human
Location Trials
China 245
Canada 189
Italy 101
Germany 99
United Kingdom 99
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Trials by US State

Trials by US State for coagulation factor ix recombinant human
Location Trials
California 69
Pennsylvania 60
Texas 58
New York 51
Maryland 49
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Clinical Trial Progress for coagulation factor ix recombinant human

Clinical Trial Phase

Clinical Trial Phase for coagulation factor ix recombinant human
Clinical Trial Phase Trials
Phase 4 248
Phase 3 195
Phase 2/Phase 3 47
[disabled in preview] 224
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Clinical Trial Status

Clinical Trial Status for coagulation factor ix recombinant human
Clinical Trial Phase Trials
Completed 522
Recruiting 181
Not yet recruiting 128
[disabled in preview] 128
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Clinical Trial Sponsors for coagulation factor ix recombinant human

Sponsor Name

Sponsor Name for coagulation factor ix recombinant human
Sponsor Trials
Bayer 25
National Cancer Institute (NCI) 22
Boehringer Ingelheim 21
[disabled in preview] 19
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Sponsor Type

Sponsor Type for coagulation factor ix recombinant human
Sponsor Trials
Other 1392
Industry 423
NIH 65
[disabled in preview] 24
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