A Phase 1 interventional study of BAY1093884 and BAY1093884 in Hemophilia A; Hemophilia B, sponsored by Bayer. Completed at 1 site in Israel. Open to male participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-09-16.
Sponsored by Bayer · Phase 1, Interventional, and Basic science
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Among 57 studies in Hemophilia A by Bayer — 3 open to participants now, 6 under way, none of them phase 3. Hemophilia A · Bayer.
Among the 57 studies in Hemophilia A by Bayer, this one is the 29th largest by enrollment of the 31 interventional ones that give a count, is one of 5 that started in 2018, is one of 10 in phase 1, and was the 40th registered.
844 studies on the registry are indexed under Hemophilia A; 136 are open to participants now.
Browse Hemophilia A studies →3 of the 57 studies in Hemophilia A by Bayer are open now, in 12 countries. Recruiting first, the newest first:
Bayer · Sites in United States, Brazil, Canada and 8 more countries
Ages 7–12
Bayer · Sites in Korea, Republic of
Ages 12+
Bayer
Ages 18+
By country, each count listing its studies:
Of the 87 Hemophilia A studies recruiting now, 51 (59%) set no upper age limit and 31 (36%) stop at 75 or younger; 55 take children under 18; 10 take healthy volunteers.
This study: 18 Years to 65 Years · male · no healthy volunteers.
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57 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 11 · Phase 2 5 · Phase 3 9 · Phase 4 8
First in 2002; this study’s year is marked. 5 started in 2018.
This study's enrollment of 6 is below the median of 30 across 499 interventional studies indexed under Hemophilia A.
Median enrollment 27 across the 31 interventional studies, 67 across the 26 observational. Of the 50 that completed or were terminated, 14 (28%) have results posted.
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Bayer is the lead sponsor of 1,674 studies on the registry; 51 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 132 (62%) have results posted.
3 of the studies in Hemophilia A by Bayer that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03932201BayerEvaluating Effectiveness and Long Term Safety of Damoctocog Alfa Pegol in Patients, Who Have Been Diagnosed With Hemophilia A | 2026-12-31 |
| NCT05643560BayerAn Observational Study Called JOIHA to Learn More About How Well the Treatment With Jivi Works to Prevent Problems With Joints in Adults With Hemophilia A. | 2027-03-31 |
| NCT04461639BayerStudy to Learn More About the Safety of Drug Jivi Over a Long Period of Time in Previously Treated Patients With Hemophilia A (Bleeding Disorder Resulting From a Lack of FVIII) Who Are Receiving Jivi Regularly at Their Treating Doctors to Prevent Bleeding | 2027-03-31 |
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Among the 57 studies in Hemophilia A by Bayer, from their registry updates:
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The primary objective of this study is to assess the pharmacokinetics in patients with severe hemophilia.
The secondary objective is to assess the pharmacodynamics of BAY1093884 based on tissue factor pathway inhibitor activity
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.
Exclusion Criteria:
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.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
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.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Single dose of BAY1093884 over 30 minutes administered in subjects with severe congenital Hemophilia A or B, with inhibitors or without inhibitors
Drug: BAY1093884
0.3 mg/kg given intravenously
1 mg/kg given intravenously
AUC (0-tlast) of BAY1093884 in plasma
Area under the concentration vs. time curve from time 0 to the last data point \> LLOQ
Time frame: Up to 15 days after drug administration
AUC(0-tlast)/D of BAY1093884 in plasma
AUC(0-tlast) divided by dose
Time frame: Up to 15 days after drug administration
Cmax of BAY1093884 in plasma
Maximum observed drug concentration in measured matrix after single dose administration
Time frame: Up to 15 days after drug administration
Cmax/D of BAY1093884 in plasma
Cmax divided by dose
Time frame: Up to 15 days after drug administration
Tissue factor plasma inhibitor activity: effect of BAY1093884 to inhibit the anticoagulatory activity of plasma TFPI as assessed by a chromogenic assay
Time frame: Up to 15 days after drug administration
Ran from May 2018 to primary completion in Oct 2018, 5 months.
Of 37 industry-sponsored phase 1 interventional studies under Hemophilia A, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 18. This study's 5 months is below that.
Counting every sponsor, half of 46 studies reached it within 13 months; a quarter within 7 and three quarters within 26.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Befovacimab