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Human Plasma-Derived Coagulation Factor VIII

Phase 3

Hemophilia A | Small molecule | Hematology |Takeda Pharmaceutical Company Limited|Last Updated: Apr 29, 2021

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment56

FDA Designations

No designations recorded

Clinical trial landscape

Human Plasma-Derived Coagulation Factor VIII · 1 trial · 1 indication

Phase 3 1
NCT00162019Pharmacokinetics, Efficacy and Safety Study of IMMUNATE SD (Human Plasma-Derived Coagulation Factor VIII Concentrate) in Hemophilia A PatientsHemophilia A
COMPLETED56 Analytics
PHASE3COMPLETED
Pharmacokinetics, Efficacy and Safety Study of IMMUNATE SD (Human Plasma-Derived Coagulation Factor VIII Concentrate) in Hemophilia A Patients
Hemophilia A
NCT0016201956
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Study Endpoints

Primary Endpoints

To compare the PK parameters of IMMUNATE S/D and IMMUNATE in subjects with severe hemophilia A (baseline factor VIII <= 1%)
Within 30 minutes pre-infusion; and at 15 minutes, 30 minutes, 1 hour, 3 hours, 6 hours, 9 hours, 24 hours, 28 hours, 32 hours, and 48 hours post-infusion.
to re-evaluate PK parameters for IMMUNATE S/D after a minimum of 14 weeks ± 7 days of treatment with at least 10 exposure days with IMMUNATE S/D
Within 30 minutes pre-infusion; and at 15 minutes, 30 minutes, 1 hour, 3 hours, 6 hours, 9 hours, 24 hours, 28 hours, 32 hours, and 48 hours post-infusion.
to monitor the incidence of factor VIII inhibitor development over a minimum of 27 weeks ± 7 days or at least 50 exposure days, whichever occurs first, in all subjects
Post-Infusion for a minimum of 27 weeks ±7 days or at least 50 treatment EDs, whichever occurs first.
to evaluate the hemostatic efficacy of IMMUNATE S/D in the management of acute bleeding episodes and in the perioperative management of surgical prophylaxis, if required, over the same period of treatment
Post-Infusion for a minimum of 27 weeks ±7 days or at least 50 treatment EDs, whichever occurs first.
to assess the clinical safety of IMMUNATE S/D
Throughout the study period of approximately 18 months.
to retrospectively explore the PK parameters of the VWF moiety of IMMUNATE S/D in subjects with severe hemophilia A (baseline factor VIII <= 1%).
Up to approximately 6.5 months
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeDIAGNOSTIC

Interventions

NameTypeDescription
Human Plasma-Derived Coagulation Factor VIII Concentrate (Virus Inactivated by Polysorbate 80 Treatment and Vapor Heat Treatment)DRUG -
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Eligibility Criteria

Age Range12 Years to 65 Years
SexMALE
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: \- Plasma factor VIII level as follows: for Parts 1 \& 3: Subjects with severe hemophilia A (plasma baseline factor VIII level \<= 1% measured at time of screening) for Part 2: Subjects with severe (plasma baseline factor VIII level \<= 1% measured at time of screening) or moder...

Countries:BulgariaCzechiaHungaryPoland
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Competitive Landscape -Hemophilia 35 trials (matched to "Hemophilia A")

CompanyTickerTrialsLead PhaseDrugs
Novo Nordisk A/S Sponsored ADR Class BNVO14PHASE3Concizumab
Sanofi SA Sponsored ADRSNY5PHASE3Fitusiran, Clotting factor concentrates or bypassing agents, Antithrombin
Pfizer Inc.PFE7PHASE3PF-06838435/ fidanacogene elaparvovec
BioMarin Pharmaceutical Inc.BMRN2PHASE3Valoctocogene roxaparvovec
Regeneron Pharmaceuticals, Inc.REGN2PHASE1REGV131, LNP1265
Takeda Pharmaceutical Co. Ltd. Sponsored ADRTAK2PHASE1AskBio009
Illumina, Inc.ILMN1 - Undisclosed
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