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Human Plasma-Derived Coagulation Factor VIII

Phase 3

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

Human Plasma-Derived Coagulation Factor VIII target and mechanism

Molecular targetINSR
Target classAgonist
ModalitySmall molecule
ChEMBLCHEMBL1201631

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment56

FDA Designations

No designations recorded

Human Plasma-Derived Coagulation Factor VIII clinical trials

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 62 trials (matched to "Hemophilia A")

Top 8 of 9 competitors

CompanyTickerTrialsLead PhaseDrugs
Novo Nordisk A/S Sponsored ADR Class BNVO15PHASE3Concizumab, Mim8, Denecimig, NNC0442-0344 A, turoctocog alfa pegol
Sanofi SA Sponsored ADRSNY5PHASE3Fitusiran, efanesoctocog alfa
Pfizer Inc.PFE8PHASE3Fidanacogene elaparvovec, Marstacimab
BioMarin Pharmaceutical Inc.BMRN2PHASE3Valoctocogene roxaparvovec
Hoffmann-La RocheRHHBY8PHASE3Emicizumab, NXT007, SPK-8011QQ, SPK-8011, SPK-8016
Regeneron Pharmaceuticals, Inc.REGN2PHASE1REGV131, LNP1265
Takeda Pharmaceutical Co. Ltd. Sponsored ADRTAK2PHASE1AskBio009
BayerBAYRY6 - Damoctocog-alfa-pegol
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Frequently asked questions about Human Plasma-Derived Coagulation Factor VIII

What is Human Plasma-Derived Coagulation Factor VIII used for?

Human Plasma-Derived Coagulation Factor VIII is used to treat Hemophilia A, a bleeding disorder. It is a plasma-derived factor VIII concentrate that has been virus inactivated through polysorbate 80 treatment and vapor heat treatment. Takeda Pharmaceutical Company Limited is developing it, and it has been studied in Hemophilia A patients aged 12 years and older.

What does Human Plasma-Derived Coagulation Factor VIII target?

Human Plasma-Derived Coagulation Factor VIII targets the insulin receptor, known as INSR, and acts as an agonist. This receptor interaction is the drug's defined molecular target according to its pharmacological classification. The therapy is being developed in the hematology therapeutic area for Hemophilia A.

Who makes Human Plasma-Derived Coagulation Factor VIII?

Takeda Pharmaceutical Company Limited makes Human Plasma-Derived Coagulation Factor VIII. Takeda trades under the ticker TAK. The company is the developer of this plasma-derived factor VIII concentrate, which is virus inactivated by polysorbate 80 treatment and vapor heat treatment.

What phase is Human Plasma-Derived Coagulation Factor VIII in?

Human Plasma-Derived Coagulation Factor VIII is in Phase 3 development. It is an investigational therapy and is not approved. The Phase 3 study has been completed, and no active trials are currently listed for this asset.

What clinical trials is Human Plasma-Derived Coagulation Factor VIII in?

Human Plasma-Derived Coagulation Factor VIII has been studied in one completed Phase 3 trial, NCT00162019. That study examined the pharmacokinetics, efficacy, and safety of the concentrate in Hemophilia A patients. It enrolled 56 participants across Bulgaria, Czechia, Hungary, and Poland, and included males aged 12 years and older.

Other drugs targeting INSR

BMS-754807 BMY· PHASE1 Human Plasma-Derived Fibrinogen GRFS· PHASE1 Human thrombin GRFS· PHASE2 Glargine LLY· PHASE3 Human Insulin LLY· PHASE3 Human regular U-500 insulin LLY· PHASE3 Insulin Efsitora Alfa LLY· PHASE3 Insulin Glargine LLY· PHASE3 Insulin Lispro LLY· PHASE3 Insulin lispro 2 day reservoir in-use LLY· PHASE3 Insulin Lispro 6 Day LLY· PHASE3 Insulin lispro A LLY· PHASE1

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