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CompletedNCT03444324AdFIrstUpdated Jun 13, 2025Results posted

Adjusted Fibrinogen Replacement Strategy

A Phase 3 interventional study of BT524 and FFP/Cryo in Bleeding Disorder and Hypofibrinogenemia; Acquired, sponsored by Biotest. Completed at 19 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-13.

Sponsored by Biotest (part of Grifols) · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
222
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

Fibrinogen is the first coagulation factor to become critically reduced during intraoperative bleeding. Therefore, rapid supplementation of fibrinogen to restore physiological plasma levels is an important component in achieving and maintaining hemostasis in bleeding patients. In this study, subjects with major blood loss during elective spinal surgery or abdominal surgery were randomized to receive either intravenous transfusion of the fibrinogen concentrate BT524, or fibrinogen-containing fresh frozen plasma/cryoprecipitate as first hemostatic intervention to rapidly replenish fibrinogen and control bleeding.

02

Conditions studied

  • Bleeding Disorder
  • Hypofibrinogenemia; Acquired

Keywords

  • Fibrinogen
03

In context

Hemostatic Disorders

361 studies on the registry are indexed under Hemostatic Disorders; 65 are open to participants now.

This study's enrollment of 222 is above the median of 60 across 171 interventional studies indexed under Hemostatic Disorders.

Browse Hemostatic Disorders studies →

Lead sponsor

Biotest is the lead sponsor of 14 studies on the registry; 1 is open to participants now.

First submitted before Biotest became part of Grifols.

Browse Biotest studies →All Grifols studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

At screening:

  1. Written
  2. Subjects scheduled for elective major spinal surgery or cytoreductive pseudomyxoma peritonei (PMP) surgery with expected major blood loss
  3. Male or female, aged ≥ 18 years
  4. No increased bleeding risk as assessed by standard coagulation tests and medical history

Intra-operative:

5.

  1. Subjects who underwent spinal surgery: Intra-operative bleeding of approximately 1 Liter, requiring hemostatic treatment during surgery.
  2. Subjects who underwent cytoreductive PMP surgery: Intra-operative prediction of clinically relevant bleeding of more than 2 Liter, requiring hemostatic treatment during surgery

Exclusion criteria

Exclusion Criteria:

  1. Pregnancy or unreliable measures or breast feeding (women only)
  2. to proteins of human origin or known hypersensitivity reactions to components of the Medicinal Products (IMP)
  3. Participation in another clinical study within 30 days before entering the study or during the study and/or previous participation in this study
  4. Treatment with any fibrinogen concentrate and/or fibrinogen-containing product within 30 days prior to infusion of IMP
  5. Employee or direct relative of an employee of the Contract Research Organization (CRO), the study site, or Biotest
  6. Inability or lacking motivation to participate in the study
  7. Medical condition, laboratory finding (e.g., biochemical or hematological findings outside the normal range), or physical exam finding that in the opinion of the investigator precludes participation
  8. Presence or history of venous/arterial thrombosis or thromboembolic event (TEE) in the preceding 6 months
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
222 participants (actual)

Study arms

  • Experimental
    BT524

    Investigational Human Fibrinogen Concentrate

    Biological: BT524

  • Active comparator
    Fresh Frozen Plasma (FFP)/Cryoprecipitate (Cryo)

    Standard of Care

    Biological: FFP/Cryo

Interventions

  • BiologicalBT524

    BT524 was administered intravenously at a patient specific dosage depending on the type of surgery, the extent of bleeding and the subject's clinical condition.

    Also known as: Human Fibrinogen concentrate

  • BiologicalFFP/Cryo

    Drug page: Human plasma

    FFP/Cryo was administered intravenously; dosage according to local standards. FFP, 15 mL per kg body weight (BW); Cryoprecipitate, fixed dose of 10 units.

    Also known as: Fresh Frozen Plasma, Cryoprecipitate

06

What researchers measure

Primary outcomes

  1. Intra-operative Blood Loss

    Intra-operative blood loss as measured by amount of blood from blood suction unit and amount of blood from surgical cloths and compresses.

    Time frame: From decision to treat the subject with IMP until end of surgery, an average of 5 hours

Secondary outcomes

  1. Proportion (%) of Subjects With Successful Correction of Fibrinogen Level (FIBTEM A10) 15 Minutes After Start of First IMP Administration

    Successful correction of the fibrinogen level is defined as restoring fibrinogen FIBTEM A10 baseline (prior surgery) levels measured by ROTEM (thromboelastometry) 15 minutes after start of first IMP administration

    Time frame: Prior first dose, 15 minutes after start of first IMP administration

  2. Time to First Successful Correction of Fibrinogen Level

    Correction of the fibrinogen level, measured via thromboelastometry (ROTEM/FIBTEM A10), within 15 minutes after IMP start, between 15 and 90 minutes after IMP start, after 90 minutes after IMP start, or unsuccessful correction. The 4 categories were compared between the two treatment arms using a Chi-square test.

    Time frame: prior 1st dose, pre-dose, 15 minutes and 90 minutes after start of first IMP administration, end of surgery

  3. Transfusion Requirements: Cell Salvage

    Total amount of transfusion products (allogeneic blood products) or autologous blood transfusion infused after start of first IMP administration until end of surgery. The end of surgery is defined as time of last suture.

    Time frame: After start of first IMP administration until end of surgery, an average of 5 hours

  4. Transfusion Requirements: Allogeneic Platelets

    Total amount of transfusion products (allogeneic blood products) or autologous blood transfusion infused after start of first IMP administration until end of surgery. The end of surgery is defined as time of last suture.

    Time frame: After start of first IMP administration until end of surgery, an average of 5 hours

  5. Transfusion Requirements: Allogeneic Red Blood Cells

    Total amount of transfusion products (allogeneic blood products) or autologous blood transfusion infused after start of first IMP administration until end of surgery. The end of surgery is defined as time of last suture.

    Time frame: After start of first IMP administration until end of surgery, an average of 5 hours

  6. Transfusion Requirements: Fresh Frozen Plasma

    Total amount of transfusion products (allogeneic blood products) or autologous blood transfusion infused after start of first IMP administration until end of surgery. The end of surgery is defined as time of last suture.

    Time frame: After start of first IMP administration until end of surgery, an average of 5 hours

  7. Transfusion Requirements, Cryoprecipitate

    Total amount of transfusion products (allogeneic blood products) or autologous blood transfusion infused after start of first IMP administration until end of surgery. The end of surgery is defined as time of last suture.

    Time frame: After start of first IMP administration until end of surgery, an average of 5 hours

  8. Amount of Red Blood Cells (RBCs)

    Amount (volume) of RBCs (allogenic and autologous RBCs) infused after start of first IMP administration until end of surgery. The end of surgery is defined as time of last suture.

    Time frame: After start of first IMP administration until end of surgery, an average of 5 hours

  9. Post-operative Blood Loss

    Post-operative drainage volume in the first 24 hours after end of surgery

    Time frame: From end of surgery (time of last suture) up to 24 hours after the end of surgery

  10. Subjects With Rebleeds

    Proportion (%) of subjects with rebleeds after the end of surgery until day 8

    Time frame: End of surgery up to 8 days after surgery

  11. Hospital Length of Stay After Surgery

    Length of stay after surgery (days) = 'date of hospital discharge' minus 'date of surgery'. Where date of discharge is the date of discharge following the IMP treated surgery.

    Time frame: From day of surgery until day of hospital discharge, an average of 16 days (up to 56 days)

  12. In-hospital Mortality

    Number and percentages of subjects who died during hospital stay

    Time frame: From day of surgery until day of hospital discharge, an average of 16 days (up to 56 days)

  13. Number of Subjects With Thrombosis or Thromboembolic Events (TEEs)

    Total number of subjects with thrombosis or TEEs documented as treatment-emergent adverse events of special interest

    Time frame: From day of surgery until closing visit (up to 181 days)

  14. Change in Viral Status

    Number of subjects with change in status of viral infections

    Time frame: Screening visit (up to 42 days prior to surgery) and closing visit (up to 181 days after surgery)

07

Results

Posted Jun 13, 2025

Participant flow

339 subjects were screened, of these 222 subjects were eligible for the study and randomized. Baseline characteristics are available for the 222 randomized subjects.

Participant flow — Overall Study
MilestoneBT524FFP/Cryo
Started110112
Completed105106
Not completed56
Withdrew: Withdrawal by subject01
Withdrew: Lost to follow-up42
Withdrew: Protocol violation01
Withdrew: Lack of trial compliance11
Withdrew: Physical disability to come to the site for the closing visit01

Outcome measures

PrimaryIntra-operative Blood Loss

Intra-operative blood loss as measured by amount of blood from blood suction unit and amount of blood from surgical cloths and compresses.

Time frame:
From decision to treat the subject with IMP until end of surgery, an average of 5 hours
Reported as:
Least squares mean · mL
Intra-operative Blood Loss
mLBT524Fresh Frozen Plasma (FFP)/Cryoprecipitate (Cryo)
Intra-operative Blood Loss1380.7 (1187.09 to 1574.31)1660.13 (1460.65 to 1859.61)
Statistical analysis
  • BT524 vs Fresh Frozen Plasma (FFP)/Cryoprecipitate (Cryo) · Van Elteren test · p = <0.001 (p-value from Van Elteren test, stratified by predictive blood loss (\> 1,000 mL to = 2,000 mL and \>2,000 mL)) · Difference in lsm: -279.43 · 95% CI -552.38 to -6.48
SecondaryProportion (%) of Subjects With Successful Correction of Fibrinogen Level (FIBTEM A10) 15 Minutes After Start of First IMP Administration

Successful correction of the fibrinogen level is defined as restoring fibrinogen FIBTEM A10 baseline (prior surgery) levels measured by ROTEM (thromboelastometry) 15 minutes after start of first IMP administration

Time frame:
Prior first dose, 15 minutes after start of first IMP administration
Reported as:
Count of participants · Participants
Proportion (%) of Subjects With Successful Correction of Fibrinogen Level (FIBTEM A10) 15 Minutes After Start of First IMP Administration
ParticipantsBT524Fresh Frozen Plasma (FFP)/Cryoprecipitate (Cryo)
Proportion (%) of Subjects With Successful Correction of Fibrinogen Level (FIBTEM A10) 15 Minutes After Start of First IMP Administration5919
Statistical analysis
  • BT524 vs Fresh Frozen Plasma (FFP)/Cryoprecipitate (Cryo) · Cochran-Mantel-Haenszel · p = <0.001 · Difference in response rate: 38.1 · 95% CI 26 to 50.3P-value is from a Cochran-Mantel-Haenszel model stratified by predictive blood loss (\> 1,000 mL to ≤ 2,000 mL and \> 2,000 mL).
SecondaryTime to First Successful Correction of Fibrinogen Level

Correction of the fibrinogen level, measured via thromboelastometry (ROTEM/FIBTEM A10), within 15 minutes after IMP start, between 15 and 90 minutes after IMP start, after 90 minutes after IMP start, or unsuccessful correction. The 4 categories were compared between the two treatment arms using a Chi-square test.

Time frame:
prior 1st dose, pre-dose, 15 minutes and 90 minutes after start of first IMP administration, end of surgery
Reported as:
Count of participants · Participants
Time to First Successful Correction of Fibrinogen Level
ParticipantsBT524Fresh Frozen Plasma (FFP)/Cryoprecipitate (Cryo)
<=15 minutes after IMP start5919
>15 and <= 90 minutes after IMP start1711
>90 minutes after IMP start1116
Unsuccessful correction2058
Statistical analysis
  • BT524 vs Fresh Frozen Plasma (FFP)/Cryoprecipitate (Cryo) · Chi-squared · p = <0.001
SecondaryTransfusion Requirements: Cell Salvage

Total amount of transfusion products (allogeneic blood products) or autologous blood transfusion infused after start of first IMP administration until end of surgery. The end of surgery is defined as time of last suture.

Time frame:
After start of first IMP administration until end of surgery, an average of 5 hours
Reported as:
Mean · mL
Transfusion Requirements: Cell Salvage
mLBT524Fresh Frozen Plasma (FFP)/Cryoprecipitate (Cryo)
Transfusion Requirements: Cell Salvage95.6 ± 244.5778.0 ± 234.77
SecondaryTransfusion Requirements: Allogeneic Platelets

Total amount of transfusion products (allogeneic blood products) or autologous blood transfusion infused after start of first IMP administration until end of surgery. The end of surgery is defined as time of last suture.

Time frame:
After start of first IMP administration until end of surgery, an average of 5 hours
Reported as:
Mean · mL
Transfusion Requirements: Allogeneic Platelets
mLBT524Fresh Frozen Plasma (FFP)/Cryoprecipitate (Cryo)
Transfusion Requirements: Allogeneic Platelets3.0 ± 30.943.6 ± 36.38
SecondaryTransfusion Requirements: Allogeneic Red Blood Cells

Total amount of transfusion products (allogeneic blood products) or autologous blood transfusion infused after start of first IMP administration until end of surgery. The end of surgery is defined as time of last suture.

Time frame:
After start of first IMP administration until end of surgery, an average of 5 hours
Reported as:
Mean · mL
Transfusion Requirements: Allogeneic Red Blood Cells
mLBT524Fresh Frozen Plasma (FFP)/Cryoprecipitate (Cryo)
Transfusion Requirements: Allogeneic Red Blood Cells455.5 ± 492.19488.4 ± 547.72
SecondaryTransfusion Requirements: Fresh Frozen Plasma

Total amount of transfusion products (allogeneic blood products) or autologous blood transfusion infused after start of first IMP administration until end of surgery. The end of surgery is defined as time of last suture.

Time frame:
After start of first IMP administration until end of surgery, an average of 5 hours
Reported as:
Mean · mL
Transfusion Requirements: Fresh Frozen Plasma
mLBT524Fresh Frozen Plasma (FFP)/Cryoprecipitate (Cryo)
Transfusion Requirements: Fresh Frozen Plasma60.5 ± 217.6814.8 ± 110.94
SecondaryTransfusion Requirements, Cryoprecipitate

Total amount of transfusion products (allogeneic blood products) or autologous blood transfusion infused after start of first IMP administration until end of surgery. The end of surgery is defined as time of last suture.

Time frame:
After start of first IMP administration until end of surgery, an average of 5 hours
Reported as:
Mean · mL
Transfusion Requirements, Cryoprecipitate
mLBT524Fresh Frozen Plasma (FFP)/Cryoprecipitate (Cryo)
Transfusion Requirements, Cryoprecipitate0 ± 00 ± 0
SecondaryAmount of Red Blood Cells (RBCs)

Amount (volume) of RBCs (allogenic and autologous RBCs) infused after start of first IMP administration until end of surgery. The end of surgery is defined as time of last suture.

Time frame:
After start of first IMP administration until end of surgery, an average of 5 hours
Reported as:
Least squares mean · mL
Amount of Red Blood Cells (RBCs)
mLBT524Fresh Frozen Plasma (FFP)/Cryoprecipitate (Cryo)
Amount of Red Blood Cells (RBCs)543.4 (441.99 to 644.77)558.9 (456.08 to 661.62)
Statistical analysis
  • BT524 vs Fresh Frozen Plasma (FFP)/Cryoprecipitate (Cryo) · ANOVA · p = <0.831 · Difference in lsm: -15.5 · 95% CI -157.83 to 126.88
SecondaryPost-operative Blood Loss

Post-operative drainage volume in the first 24 hours after end of surgery

Time frame:
From end of surgery (time of last suture) up to 24 hours after the end of surgery
Reported as:
Least squares mean · mL
Post-operative Blood Loss
mLBT524Fresh Frozen Plasma (FFP)/Cryoprecipitate (Cryo)
Post-operative Blood Loss306.3 (234.15 to 378.38)293.9 (220.76 to 366.95)
Statistical analysis
  • BT524 vs Fresh Frozen Plasma (FFP)/Cryoprecipitate (Cryo) · ANOVA · p = =0.809 · Difference in lsm: 12.4 · 95% CI -88.84 to 113.66
SecondarySubjects With Rebleeds

Proportion (%) of subjects with rebleeds after the end of surgery until day 8

Time frame:
End of surgery up to 8 days after surgery
Reported as:
Count of participants · Participants
Subjects With Rebleeds
ParticipantsBT524Fresh Frozen Plasma (FFP)/Cryoprecipitate (Cryo)
Subjects With Rebleeds05
Statistical analysis
  • BT524 vs Fresh Frozen Plasma (FFP)/Cryoprecipitate (Cryo) · Cochran-Mantel-Haenszel · p = =0.022 · Difference in proportion: -4.8 · 95% CI -8.9 to -0.7
SecondaryHospital Length of Stay After Surgery

Length of stay after surgery (days) = 'date of hospital discharge' minus 'date of surgery'. Where date of discharge is the date of discharge following the IMP treated surgery.

Time frame:
From day of surgery until day of hospital discharge, an average of 16 days (up to 56 days)
Reported as:
Count of participants · Participants
Hospital Length of Stay After Surgery
ParticipantsBT524Fresh Frozen Plasma (FFP)/Cryoprecipitate (Cryo)
>36 days74
29-36 days410
22-28 days1312
15-21 days3417
8-14 days3949
1-7 days1012
SecondaryIn-hospital Mortality

Number and percentages of subjects who died during hospital stay

Time frame:
From day of surgery until day of hospital discharge, an average of 16 days (up to 56 days)
Reported as:
Count of participants · Participants
In-hospital Mortality
ParticipantsBT524Fresh Frozen Plasma (FFP)/Cryoprecipitate (Cryo)
In-hospital Mortality00
SecondaryNumber of Subjects With Thrombosis or Thromboembolic Events (TEEs)

Total number of subjects with thrombosis or TEEs documented as treatment-emergent adverse events of special interest

Time frame:
From day of surgery until closing visit (up to 181 days)
Reported as:
Count of participants · Participants
Number of Subjects With Thrombosis or Thromboembolic Events (TEEs)
ParticipantsBT524Fresh Frozen Plasma (FFP)/Cryoprecipitate (Cryo)
Number of Subjects With Thrombosis or Thromboembolic Events (TEEs)813
SecondaryChange in Viral Status

Number of subjects with change in status of viral infections

Time frame:
Screening visit (up to 42 days prior to surgery) and closing visit (up to 181 days after surgery)
Reported as:
Count of participants · Participants
Change in Viral Status
ParticipantsBT524Fresh Frozen Plasma (FFP)/Cryoprecipitate (Cryo)
Change in Viral Status00

Adverse events

Collected over From day of surgery to closing visit (up to 181 days). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
BT5240/110 (0%)28/110 (25.5%)92/110 (83.6%)
Fresh Frozen Plasma (FFP)/Cryoprecipitate (Cryo)1/112 (0.9%)41/112 (36.6%)93/112 (83%)
Most frequent serious events
Showing 10 of 63
Most frequent serious events
EventBT524Fresh Frozen Plasma (FFP)/Cryoprecipitate (Cryo)
Pulmonary embolismRespiratory, thoracic and mediastinal disorders3/1107/112
Dural tearInjury, poisoning and procedural complications3/1100/112
Deep vein thrombosisVascular disorders1/1103/112
SeromaInjury, poisoning and procedural complications1/1103/112
Anaemia postoperativeInjury, poisoning and procedural complications0/1103/112
Postoperative wound infectionInfections and infestations1/1103/112
Impaired healingGeneral disorders2/1101/112
Wound dehiscenceInjury, poisoning and procedural complications2/1101/112
Cerebrospinal fluid leakageNervous system disorders2/1100/112
ParaparesisNervous system disorders2/1100/112
Most frequent other events
Showing 10 of 13
Most frequent other events
EventBT524Fresh Frozen Plasma (FFP)/Cryoprecipitate (Cryo)
HallucinationPsychiatric disorders29/11026/112
HypotensionVascular disorders23/11010/112
TachycardiaCardiac disorders19/11014/112
Anaemia postoperativeInjury, poisoning and procedural complications15/1106/112
HypertransaminasaemiaHepatobiliary disorders13/11011/112
NauseaGastrointestinal disorders10/1104/112
PneumoniaInfections and infestations10/11010/112
Urinary tract infectionInfections and infestations10/11010/112
Gamma-glutamyltransferase increasedInvestigations5/1108/112
Oxygen saturation decreasedInvestigations2/1107/112

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)BT524FFP/CryoTotal
<=18 years000
Between 18 and 65 years6258120
>=65 years4854102
Age, Continuous
Age, Continuous(years)BT524FFP/CryoTotal
Mean61.2 ± 12.5260.8 ± 14.0761.0 ± 13.29
Sex: Female, Male
Sex: Female, Male(Participants)BT524FFP/CryoTotal
Female6764131
Male434891
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)BT524FFP/CryoTotal
Hispanic or Latino6612
Not Hispanic or Latino103106209
Unknown or Not Reported101
Race (NIH/OMB)
Race (NIH/OMB)(Participants)BT524FFP/CryoTotal
American Indian or Alaska Native000
Asian123
Native Hawaiian or Other Pacific Islander011
Black or African American011
White109107216
More than one race000
Unknown or Not Reported011
Region of Enrollment
Region of Enrollment(participants)BT524FFP/CryoTotal
Czechia283058
Poland011
United Kingdom485098
Switzerland9918
Germany14923
Spain111324
Expected Blood Loss
Expected Blood Loss(participants)BT524FFP/CryoTotal
>1000 mL to <=2000 mL444892
>2000 mL6664130
08

Study locations

19 sites
  • Site 02
    Jette, Belgium
  • Site 01
    Leuven, Belgium
  • Site 54
    Brno, Czechia
  • Site 51
    Prague, Czechia
  • Site 53
    Prague, Czechia
  • Site 52
    Usti Nad Labem, Czechia
  • Site 15
    Bielefeld, Germany
  • Site 11
    Bonn, Germany
  • Site 12
    Hannover, Germany
  • Site 14
    München, Germany
  • Site 13
    Münster, Germany
  • Site 21
    Warschau, Poland
  • Site 31
    Barcelona, Spain
  • Site 32
    Barcelona, Spain
  • Site 33
    Barcelona, Spain
  • Site34
    Barcelona, Spain
  • Site 41
    Liestal, Switzerland
  • Site 43
    Zürich, Switzerland
  • Site 71
    Basingstoke, United Kingdom
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2018 to primary completion in Sep 2023, 65 months.

Results were first posted in Jun 2025, 1 year 8 months after primary completion.

Of 19 phase 3 interventional studies under Hemostatic Disorders, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 46. This study's 65 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 19, 2017
First posted
Feb 23, 2018
StartActual
Apr 3, 2018
Primary completionActual
Sep 25, 2023
CompletionActual
Nov 21, 2023
Results first posted
Jun 13, 2025
Last update
Jun 13, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 13, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03444324
Lead sponsor
Biotest
Collaborators
PRA Health Sciences, ICON Clinical Research
Responsible party
Sponsor
First posted
Feb 23, 2018
Start date
Apr 3, 2018
Primary completion
Sep 25, 2023
Completion
Nov 21, 2023
Results posted
Jun 13, 2025
Last update
Jun 13, 2025

Study contacts

Niels Rahe-Meyer, Prof.
principal investigator · Franziskus Hospital, Bielefeld

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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