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AskBio009

Phase 1

Hemophilia B | Monoclonal antibody | Hematology |Takeda Pharmaceutical Company Limited|Last Updated: Mar 20, 2026

Success Probability
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Market & Valuation
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Trial Design
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment30
FDA Designations
No designations recorded
Clinical trial landscape

AskBio009 · 1 trial · 1 indication

Phase 1 1
NCT01687608Open-Label Single Ascending Dose of Adeno-associated Virus Serotype 8 Factor IX Gene Therapy in Adults With Hemophilia BHemophilia B
ACTIVE NOT_RECRUITING30 Analytics
PHASE1ACTIVE NOT_RECRUITING
Open-Label Single Ascending Dose of Adeno-associated Virus Serotype 8 Factor IX Gene Therapy in Adults With Hemophilia B
Hemophilia B
NCT0168760830
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Study Endpoints
Primary Endpoints
Number of patients experiencing treatment-related adverse events by dose group
Infusion to Week 3 and Infusion to end of study
Change from baseline in clinical laboratory evaluations
Change from baseline at week 3 and change from baseline at the end of study
Secondary Endpoints
Changes from Baseline in FIX activity levels, FIX protein levels, and Bleeding Episode Severity & Frequency
At multiple timepoints from pre-dose through up to 5 years post-dose
Immune Response to AskBio009
At multiple timepoints from pre-dose through up to 5 years post-dose
Detection of AskBio009 genomes in blood, saliva, urine, stool, and semen
At multiple timepoints from pre-dose through up to 1 years post-dose
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
AskBio009 Dose EscalationEXPERIMENTALSingle Dose of a Self-Complementing Optimized Adeno-associated Virus (AAV) Serotype 8 Factor IX Gene Therapy
Interventions
NameTypeDescription
AskBio009BIOLOGICALSingle dose IV injection
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Eligibility Criteria
Age Range18 Years to 75 Years
SexMALE
Healthy VolunteersNo
Study Sites15

Inclusion Criteria: * Males age 18-75 years, inclusive * Established hemophilia B with ≥3 hemorrhages per year requiring treatment with exogenous FIX OR use of FIX prophylaxis because of history of frequent bleeding episodes * Plasma FIX activity ≤2% (\<1% for first cohort; then per protocol) * Neg...

Countries:United States
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Competitive Landscape -Hemophilia 38 trials (matched to "Hemophilia B")
CompanyTickerTrialsLead PhaseDrugs
Novo Nordisk A/S Sponsored ADR Class BNVO14PHASE3Concizumab
Sanofi SA Sponsored ADRSNY6PHASE3Fitusiran, Clotting factor concentrates or bypassing agents, Antithrombin
Pfizer Inc.PFE8PHASE3PF-06838435/ fidanacogene elaparvovec
BioMarin Pharmaceutical Inc.BMRN2PHASE3Valoctocogene roxaparvovec
Regeneron Pharmaceuticals, Inc.REGN2PHASE1REGV131, LNP1265
Takeda Pharmaceutical Co. Ltd. Sponsored ADRTAK2PHASE1AskBio009
Sangamo Therapeutics, Inc.SGMO1 - SB-318, SB-913, SB-FIX
Illumina, Inc.ILMN1 - Undisclosed
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT01687608primaryCompletionDate: changed
LOWMay 24, 2026NCT01687608studyFirstPostDate: changed