A Randomized, Active-controlled, Multicenter, Phase III Study Investigating Efficacy and Safety of Intra-operative Use of BT524 (Human Fibrinogen Concentrate) in Subjects Undergoing Major Spinal or Abdominal Surgery (AdFIrst)

The main purpose of this study was to demonstrate the efficacy and safety of intraoperative use of fibrinogen concentrate BT524, as a complementary therapy for the management of uncontrolled severe hemorrhage in acquired hypofibrinogenemia. This non-inferiority study focused on the primary objective of demonstrating that BT524 is non-inferior that means not worse than the comparator fresh frozen plasma/cryoprecipitate in reducing intraoperative blood loss when administered intravenously in subjects with acquired hypofibrinogenemia undergoing elective major spinal or abdominal surgery.

Start Date03 Apr 2018

Sponsor / Collaborator

Biotest AG

[+2]

NCT02065882

/ CompletedPhase 3

A Prospective, Open-label, Phase I/III Study Investigating Pharmacokinetic Properties of BT524 and Efficacy and Safety of BT524 in the Treatment and Prophylaxis of Bleeding in Patients With Congenital Fibrinogen Deficiency

This was a prospective, open-label, multicenter, phase I/III study investigating the 14-day single-dose pharmacokinetic and pharmacodynamic properties, efficacy and safety of BT524 following intravenous administration in the treatment or prophylaxis of bleeding in patients with congenital afibrinogenemia or severe congenital hypofibrinogenemia.

Start Date01 Mar 2013

Sponsor / Collaborator

Biotest AG

[+3]

100 Clinical Results associated with Fibrinogen, human–chmt (Grifols)

100 Translational Medicine associated with Fibrinogen, human–chmt (Grifols)

100 Patents (Medical) associated with Fibrinogen, human–chmt (Grifols)

Literatures (Medical) associated with Fibrinogen, human–chmt (Grifols)

01 May 2010·British journal of anaesthesiaQ1 · MEDICINE

Recovery of fibrinogen after administration of fibrinogen concentrate to patients with severe bleeding after cardiopulmonary bypass surgery

Q1 · MEDICINE

Article

Author: H. Schoechl ; W. Koppert ; C. Solomon ; U. Pichlmaier ; K. Raymondos ; N. Rahe-Meyer ; D. Scheinichen ; C. Hagl

BACKGROUND:

Normalization of plasma fibrinogen levels may be associated with satisfactory haemostasis and reduced bleeding. The aim of this retrospective study was to assess fibrinogen recovery parameters after administration of fibrinogen concentrate (Haemocomplettan P) to patients with diffuse bleeding in cardiovascular surgery. Data on transfusion and patient outcomes were also collected.

METHODS:

Patient characteristic and clinical data were obtained from patient records.

RESULTS:

of the thromboelastometry (FIBTEM)and of the standard coagulation tests, including plasma fibrinogen level, measured before surgery, before and after haemostatic therapy, and on the following day, were retrieved from laboratory records. Results Thirty-nine patients receiving fibrinogen concentrate for diffuse bleeding requiring haemostatic therapy after cardiopulmonary bypass were identified. The mean fibrinogen concentrate dose administered was 6.5 g. The mean fibrinogen level increased from 1.9 to 3.6 g litre(-1) (mean increment of 0.28 g litre(-1) per gram of concentrate administered); maximum clot firmness increased from 10 to 21 mm. The mean fibrinogen increase was 2.29 (sd 0.7) mg dl(-1) per mg kg(-1) bodyweight of concentrate administered. Thirty-five patients received no transfusion of fresh-frozen plasma (FFP) or platelet concentrate after receiving fibrinogen concentrate; the remaining four patients received platelet concentrate intraoperatively. Eleven patients received platelets, FFP, or both during the first postoperative day. No venous thromboses, arterial ischaemic events, or deaths were registered during hospitalization.

CONCLUSIONS:

In this retrospective study, fibrinogen concentrate was effective in increasing plasma fibrinogen level, and contributed to the correction of bleeding after cardiovascular surgery.

THROMBOSIS AND HAEMOSTASIS

Pharmacokinetics, Hemostatic Efficacy, and Safety of a New Human Fibrinogen Concentrate in Adult and Pediatric Patients with Congenital Fibrinogen Deficiency

Article

Author: Schuettrumpf, Joerg ; Abraha, Salomon ; Miesbach, Wolfgang ; Bohlaender, Fabian ; Khelif, Abderrahim ; Boehm, Heike ; Adolf, Sonia ; Meddeb, Balkis ; El-Beshlawy, Amal ; Djambas Khayat, Claudia ; Aigner, Silke

Congenital fibrinogen deficiencies are rare coagulopathies which are treated by fibrinogen concentrates. This trial investigated the pharmacokinetic/pharmacodynamic (PK/PD) parameters, and surrogate efficacy and safety of a new human fibrinogen concentrate (HFC), BT524, in patients with congenital afibrinogenemia or severe hypofibrinogenemia.This prospective, multi-national, open-label, single-arm PK/PD trial evaluated PK/PD parameters of HFC (part 1; phase I) and HFC as on-demand treatment or prophylaxis for bleeding events (part 2; phase III). In part 1, patients received a single-dose of HFC (70 mg/kg body weight [BW]). PK/PD parameters were calculated using a PK/PD model and non-compartmental analysis. Fibrinogen antigen (FiAg) levels were determined over 14 days by immunonephelometry and fibrinogen activity (FiAc) by Clauss assay. The efficacy variable was mean change in maximum clot firmness (MCF) analyzed by thromboelastometry. Safety parameters were evaluated for 49 days.A total of 27 patients (n = 15 adults, n = 12 children) were treated with HFC. For FiAg, mean (SD) PK parameters were: Cmax 1.81 (0.42) g/L, AUC0-∞ 173 (45.4) g*h/L, and t1/2 67.9 (15.3) h. For FiAc, they were Cmax 1.26 (0.4) g/L, AUC0-∞ 104 (33.5) g*h/L, and t1/2 60.3 (13.3) h. In adults, MCF significantly increased 1 h after HFC infusion (11.1 (5.1) mm; P < 0.0001; 95% CI: 9.33–14.47). In pediatrics, mean increase in range was 9.3 to 16.5 mm. Treatment-related adverse events were rare, with one mild increase in fibrin D-dimer. No thromboembolic events, hypersensitivity, or allergic reactions were observed.HFC effectively increased FiAg levels and FiAc, improved clot firmness, and showed a favorable safety and tolerability profile in adult and pediatric patients with congenital fibrinogen deficiency.

Critical care (London, England)

ROTEM®-guided coagulation factor concentrate therapy in trauma: 2-year experience in Venice, Italy

Letter

Author: Silvia Zampieri ; Manuela Toffoli ; Carlo Maggiolo ; Marco De Nardin ; Alberto Grassetto ; Debora Saggioro ; Bernadetta Ganzerla ; Antonio Bossi ; Elena Serafini ; Daniele Penzo ; Monica Geremia

Haemostatic therapy for trauma-induced coagulopathy is typically based on administration of allogeneic blood products, although the evidence supporting this approach is poor [1]. Fixed-ratio protocols have been proposed for administering fresh frozen plasma, red blood cells and platelets, but the optimal ratio has not been established and the speed of intervention may be more important [2]. In contrast to fi xed-ratio treatment, coagulation factor concentrate therapy guided by point-of-care monitoring allows patients’ actual needs to be targeted [3]. Our initial experience with ROTEM® (Tem International GmbH, Munich, Germany) indicated correlation between the clinical condition and extent of coagulo pathy, suggesting a need for the early identifi cation and treatment of coagulopathy that ROTEM® enables. Altogether, these factors provided a rationale for imple menting ROTEM®guided therapy for trauma patients in our hospital. In our experience, this approach is feasible and can replace formula-driven treatment. We found that coagulation factor concentrates (fi brinogen concentrate and prothrombin complex concentrate) correct coagulopathy eff ectively and rapidly, indicated by normalisation of ROTEM® parameters among bleeding trauma patients (Table 1). European guidelines for managing trauma raised the target fi brinogen concentra tion to 1.5 to 2 g/l [4], which we fi nd diffi cult to reach without using fi brinogen concentrate. Without a com parator group, our data are insuffi cient to show reduced red blood cell transfusion or improvements in morbidity/mortality. However, we did see a progressive reduction in fresh frozen plasma consumption. Another advantage of using a ROTEM®-guided approach is the opportunity to detect hyperfi brinolysis. As reported elsewhere, we found that fulminant hyperfi brinolysis is associated with high mortality. Fulminant hyperfi brinolysis may potentially be considered the last gasp of the coagulation system; it may be a marker not only of severe coagulopathy, but also of poor clinical outcome. Our experience also suggests that patients with massive bleeding may benefi t from immediate, proactive administration of 1 g tranexamic acid followed by 2 to 4 g fi brinogen concentrate, with further doses as soon as ROTEM® results are available. Fibrinogen concentrate is currently imported in Italy and we use it according to the manufacturer’s label. In some countries the product is licensed only for congenital defi ciency. However, it is possible to use life-saving drugs for indications beyond the label, providing the physician is convinced that this use is in the patient’s best interest; such practice is regulated by health authorities in several countries. High-quality, randomised controlled trials are lacking for both allogeneics and coagulation factor concen trates in trauma, creating a degree of uncertainty with both of these options. Nevertheless, we consider the rationale to be stronger for ROTEM®-guided, concentratebased therapy.

News (Medical) associated with Fibrinogen, human–chmt (Grifols)

23 Jun 2025

·www.biotest.com

Biotests’ positive fibrinogen phase III trial results published in The Lancet’s eClinicalMedicine

PRESS RELEASE Biotests’ positive fibrinogen phase III trial results published in The Lancet’s eClinicalMedicine The data will also be presented tomorrow as part of three abstracts at the currently ongoing International Society on Thrombosis and Haemostasis (ISTH) 2025 Congress The Phase III AdFIrst study met its primary endpoint demonstrating that Grifols fibrinogen concentrate, BT524, was non-inferior to standard of care for the treatment of bleeding in acquired fibrinogen deficiency (AFD) BT524 on track to launch in Europe later this year and, pending FDA approval, in the U.S. in early 2026 Dreieich, 23 June 2025. Biotest today announces that the positive Phase III study data on its fibrinogen concentrate, BT524, has been published in eClinicalMedicine, a peer-reviewed journal published by The Lancet Discovery Science Suite. The article1 highlights that the trial met its primary endpoint, demonstrating that treatment with BT524 is non-inferior to standard of care (SOC) with cryoprecipitate or fresh frozen plasma (FFP) in reducing clinically relevant intraoperative bleeding in patients with acquired fibrinogen deficiency (AFD) undergoing planned major spinal or abdominal surgery. Specifically, the adjusted mean of intraoperative blood loss was 1381 mL (95% confidence interval [CI] 1187–1574) in the BT524 group and 1660 mL (95% CI 1461–1860) in the FFP/cryoprecipitate group, resulting in a difference of blood loss of 279 mL between the study groups. BT524 demonstrated a positive safety profile and a statistically significant lower incidence of thromboembolic events (TEEs). Fibrinogen, a plasma protein produced in the liver, plays a key role in stopping blood loss and in wound healing. AFD is typically associated with major uncontrolled bleeding (such as during surgical procedures, trauma or postpartum hemorrhage). Low fibrinogen levels are insufficient to arrest bleeding and are commonly treated with fibrinogen sources such as cryoprecipitate. BT524 from Biotest was developed in collaboration with the Grifols Group. “The trial results, now featured in this prestigious clinical medicine journal, support the potential of BT524 to be considered for patients with clinically relevant uncontrolled bleeding,” said Dr. Jörg Schüttrumpf, CEO of Biotest AG. “We look forward to finalizing regulatory approval processes in Europe and the United States as soon as possible.” Niels Rahe-Meyer, M.D., Hannover Medical School, Germany, Department of Anesthesiology and Intensive Care Medicine, and main trial coordinator, added, “We look forward to sharing the results of the AdFIrst study more broadly with the medical community as part of the research publication and at ISTH. These data could represent a breakthrough in our understanding of hemorrhage management with fibrinogen.” Data from the study will be presented as part of three abstracts at the currently ongoing upcoming International Society on Thrombosis and Haemostais (ISTH) 2025 Congress in Washington, D.C., on June 21-25. Abstract details include: Abstract Number: PB1276 Title: Use of Fibrinogen Concentrate during Major Surgeries: Post-hoc Analysis of the Phase III AdFIrst Trial Presenter: Silke Aigner Session Date and Time: June 24, 10:50 – 11:10 a.m. (EDT) Abstract Number: PB1217 Title: Early Intra-operative Use of a Fibrinogen Concentrate in Patients Undergoing Major Abdominal Surgery Presenter: Ashok Roy Session Date and Time: June 24, 10:50 – 11:10 a.m. (EDT) Abstract Number: PB1219 Title: Efficacy and Safety of Fibrinogen Concentrate During Major Spinal Surgery: Phase III Randomized Trial Presenter: Maria José Colomina Session Date and Time: June 24, 13:45 – 14:45 p.m. (EDT) Previously AdFIrst data have been presented at congresses including the International Symposium on Intensive Care & Emergency Medicine (ISICEM); Network for the Advancement of Patient Blood Management, Haemostasis and Thrombosis (NATA); and the European Society of Anaesthesiology and Intensive Care (ESAIC). About AdFIrst trial The completed trial for Grifols’ fibrinogen concentrate (BT524), known as AdFIrst (Adjusted Fibrinogen Replacement Strategy), was a prospective, active-controlled, multicenter phase 3 non-inferiority trial investigating the efficacy and safety of BT524 in patients with acquired fibrinogen deficiency. Patients who had high blood loss during planned spinal or abdominal surgery were randomized 1:1 to treatment with BT524 or cryoprecipitate or fresh frozen plasma (FFP). To evaluate the efficacy of BT524, further blood loss was compared between both treatment options. The primary endpoint was intraoperative blood loss from the time of decision to treat until the end of surgery with a non-inferiority margin of 150 mL, assessed in the per-protocol analysis set (PPS). Safety was assessed in all patients who received at least one dose of trial drug. Further information about the trial design can be found at www.clinicaltrialsregister.eu (EudraCT number: 2017-001163-20) or ClinicalTrials.gov: NCT03444324. About fibrinogen and fibrinogen deficiency Fibrinogen is a blood clotting factor that is produced in the liver. It plays a key role in primary haemostasis (stopping blood loss from bleeding wounds) and wound healing. In case of a lack or shortage of fibrinogen the blood's ability to clot is impaired, which leads to a much greater risk of bleeding and delayed haemostasis. The fibrinogen concentrate alternatives fresh frozen plasma (FFP) and cryoprecipitate contain variable amounts of fibrinogen and must be thawed prior to treatment. The defined amount of fibrinogen in the fibrinogen concentrate will allow a tailor-made, patient specific and effective therapy. __________________________________________________________ 1) Rahe-Meyer N, et al. Efficacy and safety of human fibrinogen concentrate (BT524) in patients with major haemorrhage undergoing major orthopaedic or abdominal surgery (AdFIrst): a randomised, active-controlled, multicentre, partially blinded, phase 3 non-inferiority trial. eClinicalMedicine. 2025; 103264, https://doi-org.libproxy1.nus.edu.sg/10.1016/j.eclinm.2025.103264. About Biotest Biotest is a provider of biological therapeutics derived from human plasma. With a value added chain that extends from pre-clinical and clinical development to worldwide sales, Biotest has specialised primarily in the areas of clinical immunology, haematology and intensive care medicine. Biotest develops and markets immunoglobulins, coagulation factors and albumin based on human blood plasma. These are used for diseases of the immune and haematopoietic systems. Biotest has more than 2,500 employees worldwide. Since May 2022, Biotest has been a part of the Grifols Group, based in Barcelona, Spain (www.grifols.com). Biotest AG will now also be publishing official press releases via X. You can find us at: https://twitter.com/BiotestAG IR contact Dr Monika Baumann (Buttkereit) Phone: +49-6103-801-4406 Mail: ir@biotest.com PR contact Miriam Oehme Mail: pr@biotest.com Biotest AG, Landsteinerstr. 5, 63303 Dreieich, Germany, www.biotest.com Ordinary shares: securities’ ID No. 522720; ISIN DE0005227201 Preference shares: securities’ ID No. 522723; ISIN DE0005227235 Listing: Open Market: Berlin, Düsseldorf, Hamburg/ Hanover, Munich, Stuttgart, Tradegate Disclaimer This document contains forward-looking statements on overall economic development as well as on the business, earnings, financial and assets position of Biotest AG and its subsidiaries. These statements are based on current plans, estimates, forecasts and expectations of the company and are thus subject to risks and elements of uncertainty that could result in significant deviation of actual developments from expected developments. The forward-looking statements are only valid at the time of publication. Biotest does not intend to update the forward-looking statements and assumes no obligation to do so.

Phase 3Clinical Result

09 Jan 2025

·www.biotest.com

Important milestone for Biotest: Biologics License Application for Fibrinogen submitted to the US Food and Drug Administration (FDA)

PRESS RELEASE Important milestone for Biotest: Biologics License Application for Fibrinogen submitted to the US Food and Drug Administration (FDA) Biotest's fibrinogen aims to fulfill a high unmet medical need for additional fibrinogen to treat acquired fibrinogen deficiency US submission follows EU application for marketing authorization submitted in October 2024 Subject to FDA approval, new treatment would bring significant improvement in sales, EBIT and cash flow Dreieich, Germany, January 9, 2025. The Biologics License Application (BLA) for Biotest’s Fibrinogen has been submitted to the US Food and Drug Administration. Fibrinogen is the second product developed and manufactured by Biotest in Dreieich, Germany, for which a BLA has been submitted to the FDA. The new application covers both supplementation in patients with acquired fibrinogen deficiency and treatment and prophylaxis of acute bleeding episodes in all patients with congenital fibrinogen deficiency. The application is now under evaluation by the FDA, with a decision anticipated by the end of 2025. This submission follows Biotest's earlier application for marketing authorization in selected European markets filed in October 2024. “Clinical data demonstrates efficacy and safety of Biotest's Fibrinogen in various bleeding conditions,” said Dr. Christina Erb, Head of Scientific Operations and Innovation. “Fibrinogen deficiency can lead to uncontrolled blood loss potentially resulting in patient’s death. Biotest’s Fibrinogen can be stored at room temperature and is designed to be more convenient and faster to prepare than alternatives for the treatment of fibrinogen deficiency associated with severe blood loss. As such, it will provide an effective and safe option for the management of bleeding in patients with serious and potentially life-threatening conditions”. In many regions of the world, the use of cryoprecipitate or fresh frozen plasma as a fibrinogen substitute is the standard of care for the management of major surgical bleeding. However, these treatments contain not only fibrinogen, but also additional proteins and components that may exhibit undesired effects for the patient. In addition, they are not subject to the same rigorous pathogen safety protocols as Fibrinogen. Fibrinogen also offers the significant advantages of being readily available and allowing for faster administration, ensuring timely and targeted treatment. As a member of the Grifols Group, Biotest is committed to playing a leading role in expanding access to this therapy to a broader patient population. About Biotest’s Fibrinogen The newly developed manufacturing process for fibrinogen results in high-purity fibrinogen with a defined concentration, high level of viral safety and good solubility. About AdFIrst trial no. 995 The AdFIrst trial was a prospective, active-controlled, multicentre phase III trial investigating the efficacy and safety of Fibrinogen (BT524) in patients with acquired fibrinogen deficiency. Patients experiencing high blood loss during planned spinal or abdominal surgery were randomized 1:1 to treatment with Fibrinogen (BT524) or fresh frozen plasma (FFP)/cryoprecipitate. To evaluate the efficacy of BT524, blood loss was compared between the two treatment options. For more information on the trial design and outcomes, please visit www.clinicaltrialsregister.eu (EudraCT number: 2017-001163-20). Full trial results are expected to be published in a medical journal later in 2025. About fibrinogen and fibrinogen deficiency Fibrinogen is a blood clotting factor that is produced in the liver. It plays a key role in primary haemostasis (stopping blood loss from bleeding wounds) and wound healing. In case of a lack or shortage of fibrinogen blood's ability to clot is impaired which leads to a much greater risk of bleeding and delayed haemostasis. The Fibrinogen alternatives fresh frozen plasma (FFP) and cryoprecipitate contain variable amounts of fibrinogen and must be thawed prior to administration. The defined amount of fibrinogen in the fibrinogen developed by Biotest will allow a tailor-made, patient specific and highly effective treatment. About Biotest Biotest (www.biotest.com) is a provider of biological therapeutics derived from human plasma. With a value-added chain that extends from preclinical and clinical development to worldwide sales, Biotest has specialized primarily in the areas of clinical immunology, hematology, and intensive care medicine. Biotest develops and markets immunoglobulins, coagulation factors and albumin based on human blood plasma. These are used for diseases of the immune and hematopoietic systems. Biotest has more than 2,400 employees worldwide. The ordinary and preference shares of Biotest AG are listed in the Prime Standard on the German Stock Exchange. Since May 2022, Biotest has been a part of the Grifols Group, headquartered in Barcelona, Spain (www.grifols.com). IR contact Dr Monika Baumann (Buttkereit) Phone: +49-6103-801-4406 Mail: ir@biotest.com PR contact Dirk Neumüller Phone: +49-6103-801-269 Mail: pr@biotest.com Biotest AG, Landsteinerstr. 5, 63303 Dreieich, Germany, www.biotest.com Ordinary shares: securities’ ID No. 522720; ISIN DE0005227201 Preference shares: securities’ ID No. 522723; ISIN DE0005227235 Listing: Frankfurt (Prime Standard) Open Market: Berlin, Düsseldorf, Hamburg/ Hanover, Munich, Stuttgart, Tradegate Disclaimer This document contains forward-looking statements on overall economic development as well as on the business, earnings, financial and assets position of Biotest AG and its subsidiaries. These statements are based on current plans, estimates, forecasts and expectations of the company and are thus subject to risks and elements of uncertainty that could result in significant deviation of actual developments from expected developments. The forward-looking statements are only valid at the time of publication. Biotest does not intend to update the forward-looking statements and assumes no obligation to do so.

Clinical ResultPhase 3

17 Jun 2024

·www.pharmaceutical-technology.com

Biotest wins FDA approval for plasma protein therapy

The FDA approved Biotest’s plasma protein therapy as per a 17 June press release. Credit: Biotest. Biotest , a subsidiary of Grifols , announced that the US FDA granted approval for its plasma protein therapy Yimmugo earlier today (17 June). Yimmugo is an intravenous immunoglobulin therapy developed as a substitution therapy for primary antibody deficiency syndromes. The Barcelona, Spain-headquartered company launched the therapy in Europe in late 2022, receiving European Medicines Agency (EMA) approval for production and marketing. Biotest is developing the therapy at a production facility in Dreieich, Germany. The therapy uses a polyvalent immunoglobulin G preparation from human blood plasma for producing intravenous administration (IVIg). Antibody deficiency syndrome is caused by an immunoglobulin level significantly under the standard range or a failure of immunoglobulin function. The primary form of the condition is developed due to genetic defects that dysregulate B cell development and/or function. Earlier this year, Biotest announced an 83.6% increase in first-quarter (Q1) sales driven by Yimmugo. The company reported revenues of €215.2m ($230.5m) in Q1 2024, with Yimmugo’s sales jumping from €7.5m to €11.1m. In a 17 June press release, Peter Janssen, Biotest’s CEO, said: “With this approval, we aim to increase the availability of and access to immunoglobulin therapies worldwide, thereby improving patient care.” See Also: Johnson & Johnson seeks FDA approval for Tremfya for Crohn’s disease AstraZeneca’s Truqap and Faslodex combo receives approval in EU Alongside Yimmugo, Biotest has been developing two other plasma proteins. One of these is a fibrinogen concentrate therapy, AdFIrst (BT524), for the treatment of acquired fibrinogen deficiency. In 2021, Biotest came under Grifols via the acquisition of Tiancheng Pharmaceutical, which owned a majority of the shares in Biotest. Earlier this year, Grifols’ chief scientific innovations officer, Jörg Schüttrumpf, said the company has the capability to manufacture Adfirst in-house . Grifols released a positive readout from a Phase III AdFIrst study (2017-001163-20) in February 2024, demonstrating that the therapy was non-inferior to the standard of care. Biotest is also developing trimodulin (BT-588), a plasma protein treatment for severe community-acquired pneumonia. The pharma company is currently investigating the therapy in the Phase III ESsCAPE study (NCT05722938).

Clinical ResultDrug ApprovalPhase 3ImmunotherapyAcquisition

100 Deals associated with Fibrinogen, human–chmt (Grifols)

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Afibrinogenemia	United States	Grifols Therapeutics LLC	16 Dec 2025
Hemorrhage	United States	Grifols Therapeutics LLC	16 Dec 2025

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Hypodysfibrinogenemia, Congenital	Phase 3	Bulgaria	Biotest AG	01 Mar 2013
Hypodysfibrinogenemia, Congenital	Phase 3	Egypt	Biotest AG	01 Mar 2013
Hypodysfibrinogenemia, Congenital	Phase 3	Germany	Biotest AG	01 Mar 2013
Hypodysfibrinogenemia, Congenital	Phase 3	Lebanon	Biotest AG	01 Mar 2013
Hypodysfibrinogenemia, Congenital	Phase 3	Tunisia	Biotest AG	01 Mar 2013

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02065882 (CTgov)	Phase 3	Hemorrhage \| Hypodysfibrinogenemia, Congenital \| Afibrinogenemia	67	BT524+Fibrinogen (BT524 (Human Fibrinogen Concentrate))	wgvvtldray(codbmfqfxm) = dydrvanvrp geohtytsot (rgmqpxgxde, 15.3) View more	-	03 Jul 2025
				BT524 (Part I)	yltbejaetc(rxdjwgybfl) = hxakzmdxcl wwpchmoldb (ydwkbannnq, 5.07) View more
NCT03444324 (AdFIrst, CTgov)	Phase 3	Afibrinogenemia	222	BT524 (BT524)	jnxlkanefn(azzmdwjulx) = ujzfxikujk kyljypoxdj (vvdfgldvkl, czuijvaici - irugeqzoli) View more	-	13 Jun 2025
				FFP/Cryo (Fresh Frozen Plasma (FFP)/Cryoprecipitate (Cryo))	jnxlkanefn(azzmdwjulx) = ephicwmtix kyljypoxdj (vvdfgldvkl, fdbwrkvcel - qgdmgejlnn) View more
PF1255 (EHA2025)	Not Applicable	Afibrinogenemia	36	Fibrinogen Concentrate from Human Plasma	loppsalsml(qxloeegwev) = Overall hemostatic response was considered successful in 98.9% of all patients, 100% of all the pediatric age groups and 96% of adult patients yrayxjajrs (weqtxapxxc ) View more	Positive	14 May 2025
ASH2024	Not Applicable	Afibrinogenemia	-	Human Fibrinogen Concentrate (HFC)	yoakvpuiuy(lrdgjeezpj) = A total of 31 treatment-emergent adverse events (TEAEs) were reported in 15 (55.6%) patients vbhjefloyb (afmerptciu ) View more	-	07 Dec 2024
NCT03444324 \| EUCTR2017-001163-20-DE (AdFIrst, Corporate Publications) Manual	Phase 3	Acquired fibrinogen deficiency	222	BT524	eqpyrsifrq(cpkswkybvp) = btolitaslk kwnjsfdwcf (nbuecfulaq ) Met	Positive	14 Feb 2024
				Standard of Care	eqpyrsifrq(cpkswkybvp) = znsdyczjma kwnjsfdwcf (nbuecfulaq ) Met

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