A Phase 1 interventional study of Damoctocog (Jivi, BAY94-9027) and Elocta in Hemophilia A, sponsored by Bayer. Completed at 1 site in Bulgaria. Open to male participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-09-09.
Sponsored by Bayer · Phase 1, Interventional, and Basic science
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Among 12 studies testing factor VIII-Fc fusion protein in Hemophilia A — none open to participants now, none under way, none of them phase 3. factor VIII-Fc fusion protein · Hemophilia A.
Among the 12 studies testing factor VIII-Fc fusion protein in Hemophilia A, this one is the 7th largest by enrollment, is one of 3 that started in 2017, is one of 4 in phase 1, and was the 10th registered.
844 studies on the registry are indexed under Hemophilia A; 136 are open to participants now.
Browse Hemophilia A studies →None of the 12 studies testing factor VIII-Fc fusion protein in Hemophilia A is open now. The open studies under Hemophilia A, anywhere →
factor VIII-Fc fusion protein: first FDA approval 2014 (Eloctate), first EMA approval 2015. What it is approved for, and how studies give it, is on its page →
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.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
12 studies; the count open now beside each. This study's row is marked.
First in 2009; this study’s year is marked. 3 started in 2017.
This study's enrollment of 18 is below the median of 30 across 499 interventional studies indexed under Hemophilia A.
Median enrollment 19 across the 12 interventional studies. Of the 11 that completed or were terminated, 7 (64%) have results posted.
This tab as a report to print or save as PDF → With an account.
9 of 12 have an industry lead sponsor. The 7 most frequent:
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.
57 studies in Hemophilia A by Bayer: 3 open now, 6 under way, none of them phase 3. Of 50 finished, 14 (28%) have results posted.
Among the 57 studies in Hemophilia A by Bayer, this one is the 20th largest by enrollment of the 31 interventional ones that give a count, is one of 2 that started in 2017, is one of 10 in phase 1, and was the 38th registered.
Bayer’s Hemophilia A studies by the year they started, since 2002.
None of the studies under way reaches primary completion within a year.
Among the 12 studies testing factor VIII-Fc fusion protein in Hemophilia A, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among Bayer’s 57 in Hemophilia A:
This tab as a report to print or save as PDF → With an account.
The purpose of this study is to compare the pharmacokinetics of BAY94-9027 and Elocta after intravenous administration.
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.
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.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
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.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects received two treatments: 60 IU/kg BAY94-9027 in the first period, followed by 60 IU/kg Elocta in the second period, with a washout period before each treatment
Drug: Damoctocog (Jivi, BAY94-9027) · Drug: Elocta
Subjects received two treatments: 60 IU/kg Elocta in the first period, followed by 60 IU/kg BAY94-9027 in the second period, with a washout period before each treatment
Drug: Damoctocog (Jivi, BAY94-9027) · Drug: Elocta
60 international units (IU)/kg, given as a 10 minute injection, 1 dose
60 IU/kg, given as a 10 minute injection, 1 dose
AUC from time 0 to the last data point
Area under the concentration time profile curve.
Time frame: Pre-Dose and up to 120 hours post dose
Ran from Nov 2017 to primary completion in Jan 2018, 1 month.
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 1 month 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 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Factor VIII-Fc fusion protein