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Recombinant Human Coagulation FVIII

Phase 3

Hemophilia A | Small molecule | Hematology |IQVIA Holdings, Inc.|Last Updated: Feb 6, 2020

Development status

Highest phase Phase 3
Registered trials 1 across 1 sponsor since Jan 2019

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment73

FDA Designations

No designations recorded

Clinical trial landscape

Recombinant Human Coagulation FVIII · 1 trial · 1 indication

Phase 3 1
NCT03815318Evaluation of SCT800 in Prophylaxis Therapy on Previous Treated Patients With Severe Hemophilia AHemophilia A
COMPLETED73 Analytics
PHASE3COMPLETED
Evaluation of SCT800 in Prophylaxis Therapy on Previous Treated Patients With Severe Hemophilia A
Hemophilia A
NCT0381531873
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Study Endpoints

Primary Endpoints

Annualized Bleeding Rate
up to 24 weeks

Annualized Bleeding Rate（ABR） can be calculated using the following formula: Number of bleeding events in efficacy evaluation period/(number of days in treatment period/365.25)

Secondary Endpoints

Annualized joint bleeding rate
up to 24 weeks
FVIII incremental in-vivo recovery
Predose within 30 min，15 min±2 min、1 hour±5 min.
Bleeding event treatment efficacy
up to 24 weeks
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Recombinant Human Coagulation FVIIIEXPERIMENTALParticipant receivedSCT800 for prophylaxis with 25 - 50 IU/kg injection once every other day or three times per week for 6 months.

Interventions

NameTypeDescription
Recombinant Human Coagulation FVIIIDRUGParticipant received SCT800 for prophylaxis with 25 - 50 IU/kg injection once every other day or three times per week for 6 months.
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Eligibility Criteria

Age Range12 Years to 65 Years
SexMALE
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Aged ≥12 years old and ≤65 years old; * Male patients who are clinically diagnosed with severe (laboratory tested FVIII:C \<1%) hemophilia A, including historical FVIII:C \<1%; * Previously received FVIII treatment (prophylactic or bleeding treatment), have the relevant record...

Countries:China
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Competitive Landscape -Hemophilia 34 trials (matched to "Hemophilia A")

Top 6 of 7 competitors

CompanyTickerTrialsLead PhaseDrugs
Novo Nordisk A/S Sponsored ADR Class BNVO14PHASE3Concizumab, Mim8, NNC0442-0344 A, turoctocog alfa pegol, nonacog beta pegol
Pfizer Inc.PFE7PHASE3Fidanacogene elaparvovec, Marstacimab
Sanofi SA Sponsored ADRSNY4PHASE3Fitusiran, efanesoctocog alfa
BioMarin Pharmaceutical Inc.BMRN2PHASE3Valoctocogene roxaparvovec
Regeneron Pharmaceuticals, Inc.REGN2PHASE1REGV131, LNP1265
Takeda Pharmaceutical Co. Ltd. Sponsored ADRTAK2PHASE1AskBio009
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