CLINICAL TRIALS PROFILE FOR FIBRINOGEN, I-125

505(b)(2) Clinical Trials for Fibrinogen, I-125

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
OTC	NCT00169299 ↗	Herbal Alternatives for Menopause Symptoms (HALT Study)	Unknown status	National Center for Complementary and Integrative Health (NCCIH)	Phase 4	2001-06-01	Surveys indicate that 25 to 33% of women have moderate to severe menopausal symptoms including hot flashes, night sweats, and disturbed sleep. The treatment of choice in the medical community for these symptoms is hormone replacement therapy, which is estrogen and sometimes progestin. Many women also use over-the-counter herbal remedies. However, less is known about how well these products work, or their safety. Few have undergone the kind of rigorous testing required of prescription drugs and little is known about their long-term effectiveness in relieving symptoms. The purpose of this study is to compare several over-the-counter herbal remedies to hormone replacement therapy. Our primary aim is to look at the effects of these remedies on your self-reported menopausal symptoms. We will also be measuring their effects on other factors known to be affected by hormone replacement therapy: cholesterol, blood sugar, bone density, vaginal cell structure, and blood clotting.
OTC	NCT00169299 ↗	Herbal Alternatives for Menopause Symptoms (HALT Study)	Unknown status	National Institute on Aging (NIA)	Phase 4	2001-06-01	Surveys indicate that 25 to 33% of women have moderate to severe menopausal symptoms including hot flashes, night sweats, and disturbed sleep. The treatment of choice in the medical community for these symptoms is hormone replacement therapy, which is estrogen and sometimes progestin. Many women also use over-the-counter herbal remedies. However, less is known about how well these products work, or their safety. Few have undergone the kind of rigorous testing required of prescription drugs and little is known about their long-term effectiveness in relieving symptoms. The purpose of this study is to compare several over-the-counter herbal remedies to hormone replacement therapy. Our primary aim is to look at the effects of these remedies on your self-reported menopausal symptoms. We will also be measuring their effects on other factors known to be affected by hormone replacement therapy: cholesterol, blood sugar, bone density, vaginal cell structure, and blood clotting.
OTC	NCT00169299 ↗	Herbal Alternatives for Menopause Symptoms (HALT Study)	Unknown status	Group Health Cooperative	Phase 4	2001-06-01	Surveys indicate that 25 to 33% of women have moderate to severe menopausal symptoms including hot flashes, night sweats, and disturbed sleep. The treatment of choice in the medical community for these symptoms is hormone replacement therapy, which is estrogen and sometimes progestin. Many women also use over-the-counter herbal remedies. However, less is known about how well these products work, or their safety. Few have undergone the kind of rigorous testing required of prescription drugs and little is known about their long-term effectiveness in relieving symptoms. The purpose of this study is to compare several over-the-counter herbal remedies to hormone replacement therapy. Our primary aim is to look at the effects of these remedies on your self-reported menopausal symptoms. We will also be measuring their effects on other factors known to be affected by hormone replacement therapy: cholesterol, blood sugar, bone density, vaginal cell structure, and blood clotting.

All Clinical Trials for Fibrinogen, I-125

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000466 ↗	Postmenopausal Estrogen/Progestin Interventions (PEPI)	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 3	1987-09-01	To assess the effects of various postmenopausal estrogen replacement therapies on selected cardiovascular risk factors, including high density lipoprotein cholesterol, systolic blood pressure, fibrinogen, and insulin and on osteoporosis risk factors. Conducted in collaboration with the National Institute of Child Health and Human Development, the National Institute of Arthritis and Musculoskeletal and Skin Diseases, The National Institute of Diabetes and Digestive and Kidney Diseases, and the National Institute on Aging. The extended follow-up is for 3 years focusing on endometrium and breast evaluation.
NCT00000466 ↗	Postmenopausal Estrogen/Progestin Interventions (PEPI)	Completed	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)	Phase 3	1987-09-01	To assess the effects of various postmenopausal estrogen replacement therapies on selected cardiovascular risk factors, including high density lipoprotein cholesterol, systolic blood pressure, fibrinogen, and insulin and on osteoporosis risk factors. Conducted in collaboration with the National Institute of Child Health and Human Development, the National Institute of Arthritis and Musculoskeletal and Skin Diseases, The National Institute of Diabetes and Digestive and Kidney Diseases, and the National Institute on Aging. The extended follow-up is for 3 years focusing on endometrium and breast evaluation.
NCT00000466 ↗	Postmenopausal Estrogen/Progestin Interventions (PEPI)	Completed	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 3	1987-09-01	To assess the effects of various postmenopausal estrogen replacement therapies on selected cardiovascular risk factors, including high density lipoprotein cholesterol, systolic blood pressure, fibrinogen, and insulin and on osteoporosis risk factors. Conducted in collaboration with the National Institute of Child Health and Human Development, the National Institute of Arthritis and Musculoskeletal and Skin Diseases, The National Institute of Diabetes and Digestive and Kidney Diseases, and the National Institute on Aging. The extended follow-up is for 3 years focusing on endometrium and breast evaluation.

Clinical Trial Conditions for Fibrinogen, I-125

Condition Name

Condition Name for Fibrinogen, I-125
Intervention	Trials
Bleeding	10
Trauma	8
Cardiovascular Diseases	7

Condition MeSH

Condition MeSH for Fibrinogen, I-125
Intervention	Trials
Hemorrhage	41
Hemostatic Disorders	20
Blood Coagulation Disorders	20

Clinical Trial Locations for Fibrinogen, I-125

Trials by Country

Trials by Country for Fibrinogen, I-125
Location	Trials
United States	121
Canada	26
Italy	16
France	15
Indonesia	13

Trials by US State

Trials by US State for Fibrinogen, I-125
Location	Trials
Maryland	9
Pennsylvania	8
Massachusetts	7
New York	7
Florida	7

Clinical Trial Progress for Fibrinogen, I-125

Clinical Trial Phase

Clinical Trial Phase for Fibrinogen, I-125
Clinical Trial Phase	Trials
Phase 4	77
Phase 3	47
Phase 2/Phase 3	13

Clinical Trial Status

Clinical Trial Status for Fibrinogen, I-125
Clinical Trial Phase	Trials
Completed	126
Recruiting	38
Unknown status	29

Clinical Trial Sponsors for Fibrinogen, I-125

Sponsor Name

Sponsor Name for Fibrinogen, I-125
Sponsor	Trials
CSL Behring	8
University of Sao Paulo	6
Tel-Aviv Sourasky Medical Center	4

Sponsor Type

Sponsor Type for Fibrinogen, I-125
Sponsor	Trials
Other	396
Industry	70
NIH	14

Clinical Trials, Market Analysis, and Projections for Fibrinogen Concentrates

Introduction to Fibrinogen Concentrates

Fibrinogen, a crucial plasma protein, plays a vital role in blood clotting and wound healing. Fibrinogen concentrates are used to treat various conditions, including congenital fibrinogen deficiency, acquired fibrinogen deficiency, and to manage bleeding during surgical procedures.

Clinical Trials Update

Fibryna (Fibrinogen Concentrate)

• Clinical Studies: The FDA has reviewed clinical studies for Fibryna, a fibrinogen concentrate, under the investigational new drug (IND) 14777. These studies, FORMA 01 and FORMA 02, were conducted to evaluate the safety and efficacy of Fibryna in treating acute bleeding episodes in adults and children with congenital fibrinogen deficiency. FORMA 01, a phase 2 crossover pharmacokinetic and pharmacodynamic study, showed that a single dose of Fibryna at 70mg/kg significantly increased plasma fibrinogen levels, supporting its efficacy[1].

• Efficacy and Safety: The studies demonstrated a high hemostatic efficacy, with 95% of bleeding episodes achieving successful hemostatic outcomes. The safety profile was favorable, with no thrombotic events, deaths, or discontinuations due to adverse events reported in the subjects who achieved target plasma fibrinogen levels[1].

BT524 (Biotest’s Fibrinogen Concentrate)

• AdFIrst Study: Grifols announced positive topline results from the AdFIrst phase 3 clinical trial for BT524, a fibrinogen concentrate developed by Biotest. The trial showed that BT524 is non-inferior to standard of care in reducing intraoperative blood loss in patients with acquired fibrinogen deficiency (AFD), while maintaining an excellent safety profile. This product is set to enter regulatory approval processes in Q4 2024 in Europe and the United States[4].

• Regulatory Approval: If approved, BT524 would be the first fibrinogen concentrate approved for AFD in the U.S., addressing a significant unmet need in a market estimated to be worth USD 800 million[4].

FIBRYGA

• Clinical Approval: FIBRYGA, another human plasma-derived fibrinogen concentrate, is approved in Canada and the EMA for acquired fibrinogen deficiency. The approval was based on the FIBRES study, which compared FIBRYGA to cryoprecipitate. The study showed that FIBRYGA effectively increased fibrinogen levels and had a comparable safety profile to cryoprecipitate[5].

Market Analysis

Current Market Size and Growth

• The global fibrinogen concentrate market was valued at US$ 929.9 million in 2024 and is projected to reach US$ 2207.6 million by 2030, growing at a Compound Annual Growth Rate (CAGR) of 15.5% during the forecast period. This significant growth is driven by increasing demand for effective treatments for bleeding disorders and surgical bleeding management[2].

Key Players

• The market is dominated by several key players, including Shanghai RAAS, Boya, Hualan Biological Engineering, Harbin Pacific Biopharmaceutical, Greencross, Shanghai XinXing Medical, and Octapharma. These companies are investing heavily in research and development to enhance their product portfolios and expand their market share[2].

Applications and Types

• Applications: Fibrinogen concentrates are primarily used in surgical procedures, treating congenital fibrinogen deficiency, and managing acquired fibrinogen deficiency. The increasing number of surgical procedures and the growing awareness of bleeding disorders are driving the demand for these products[2].

• Types: The market includes human fibrinogen concentrates, which are highly purified and derived from human plasma. These products are preferred due to their high efficacy and safety profiles[2].

Market Projections

Future Growth Drivers

• The market is expected to grow significantly due to several factors, including the increasing incidence of bleeding disorders, advancements in medical technology, and the expanding use of fibrinogen concentrates in surgical procedures. The approval of new products, such as BT524, will also contribute to market growth[2][4].

Regional Market

• The global market is segmented by region, with North America, Europe, and Asia-Pacific being key markets. The growth in these regions is driven by the presence of major healthcare facilities, increasing healthcare expenditure, and a high prevalence of bleeding disorders[2].

Key Takeaways

• Clinical Trials: Recent clinical trials for fibrinogen concentrates, such as Fibryna and BT524, have shown promising results in treating bleeding disorders and managing surgical bleeding.
• Market Growth: The global fibrinogen concentrate market is expected to grow at a CAGR of 15.5% from 2024 to 2030, driven by increasing demand and advancements in medical technology.
• Key Players: Major companies like Shanghai RAAS, Boya, and Octapharma are leading the market with their innovative products and extensive research and development efforts.
• Applications: Fibrinogen concentrates are widely used in surgical procedures and for treating congenital and acquired fibrinogen deficiencies.

FAQs

What are the primary indications for fibrinogen concentrates?

Fibrinogen concentrates are primarily indicated for the treatment of acute bleeding episodes in adults and children with congenital fibrinogen deficiency and for managing acquired fibrinogen deficiency during surgical procedures.

Which companies are leading the fibrinogen concentrate market?

Key players in the market include Shanghai RAAS, Boya, Hualan Biological Engineering, Harbin Pacific Biopharmaceutical, Greencross, Shanghai XinXing Medical, and Octapharma.

What is the projected growth rate of the global fibrinogen concentrate market?

The global fibrinogen concentrate market is expected to grow at a Compound Annual Growth Rate (CAGR) of 15.5% from 2024 to 2030.

What are the main applications of fibrinogen concentrates?

The main applications include surgical procedures, treating congenital fibrinogen deficiency, and managing acquired fibrinogen deficiency.

Are there any new fibrinogen concentrates in the regulatory approval pipeline?

Yes, BT524, developed by Biotest, is set to enter regulatory approval processes in Q4 2024 in Europe and the United States for the treatment of acquired fibrinogen deficiency[4].

Sources

1. FDA Clinical Review Memo: "Clinical Review Memo, June 6, 2017 - FIBRYNA - FDA"[1]
2. Global Fibrinogen Concentrate Market Insights: "Global Fibrinogen Concentrate Market Insights, Forecast to 2030"[2]
3. Global Fibrinogen Market Research Report: "Global Fibrinogen Market Research Report, Competitive Landscape, and Forecast"[3]
4. Grifols Announces Positive Topline Phase 3 Fibrinogen Clinical Trial Results: "Grifols announces positive topline phase 3 fibrinogen clinical trial results"[4]
5. FDA Clinical Review Memo - FIBRYGA: "July 31, 2024 Clinical Review Memo-FIBRYGA - FDA"[5]

Last updated: 2025-01-02