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Recomb. Factor VIII

Phase 1

Hemophilia A | Monoclonal antibody | Hematology |Bayer AG|Last Updated: Nov 18, 2014

Target and mechanism

ModalityMonoclonal antibody

Also known as Recomb. Factor VIII (Kogenate FS Liposome, BAY79-4980)

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment27

FDA Designations

No designations recorded

Clinical trial landscape

Recomb. Factor VIII · 1 trial · 1 indication

Phase 1 1
NCT00629837Pharmacokinetics and Safety of a Single Intravenous Infusion of BAY 79-4980Hemophilia A
COMPLETED27 Analytics
PHASE1COMPLETED
Pharmacokinetics and Safety of a Single Intravenous Infusion of BAY 79-4980
Hemophilia A
NCT0062983727
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Study Endpoints

Primary Endpoints

To determine the pk profile after single administration of two doses of BAY 79-4980 (high and low: 35 IU FVIII/Kg reconstituted in 22 mg and 13 mg of liposomes/kg, respectively) compared to rFVIII-FS (35 IU/Kg reconstituted in 2.5 mL WFI/1000 IU) in PTPs
6 weeks

Secondary Endpoints

To determine the infusion tolerability of both BAY 79-4980 doses, by evaluation of vital signs and adverse events
6 weeks
To determine the safety of both BAY 79-4980 doses by measuring the effects on laboratory parameters - especially the lipid profile and adverse events
6 weeks
To determine the pk characteristics of liposomes - esp body clearance by measuring the major liposome component 1-palmitoyl-2-oleoyl-sn-glycerol-3-phosphocholine (POPC) and the non-biological liposome component, MPEG 2000 DSPE, as surrogate marker
6 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm 1EXPERIMENTAL -
Arm 2EXPERIMENTAL -
Arm 3ACTIVE_COMPARATOR -
Arm 4ACTIVE_COMPARATOR -

Interventions

NameTypeDescription
Recomb. Factor VIII (Kogenate FS Liposome, BAY79-4980)BIOLOGICALLow dose of BAY 79-4980 \[13mg of liposomes/kg\] then cross over to rFVIII-FS (35 IU/kg reconstituted in 2.5 mL WFI / 1000 IU).
Recombinant Factor VIII (Kogenate FS, BAY14-2222)BIOLOGICALrFVIII-FS (35 IU/kg reconstituted in 2.5mL WFI /1000 IU) then cross over to low dose of BAY 79-4980 \[13mg of liposomes/kg\]
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Eligibility Criteria

Age Range12 Years to 60 Years
SexMALE
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Males aged 12 to 60 years * Hemophilia A with plasma FVIII level less than 1% (severe hemophilia) * No history of FVIII inhibitor antibody formation and no current evidence of inhibitor antibody measured using the Nijmegen modified Bethesda assay (\< 0.6 Nijmegen Bethesda Unit...

Countries:United States
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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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