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PHY606

Phase 3

Anemia | Small molecule | Hematology |China Pharma Holdings, Inc.|Last Updated: Aug 16, 2021

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindNO_TREATMENT_CONTROLLED
Total Trials1
Total Enrollment39
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04974073Development of PHY606 as Adjunct Therapy for Anemia PatientsPHASE3 COMPLETED 39Aug 22, 2017Nov 18, 2019Aug 16, 20211 Taiwan
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Study Endpoints
Primary Endpoints
Constitution in Chinese Medicine Questionnaire (CCMQ)
Change from baseline CCMQ at Day0, Day31, Day93 and Day180.
Serum Cytokines
Change from baseline serum cytokines at Day0, Day31 and Day93.

Collect blood and measure the level of serum cytokines.

Secondary Endpoints
Tongue diagnosis
Change from baseline tongue diagnosis at Day0 and Day93.
Pulse diagnosis
Change from baseline Pulse diagnosis at Day0 and Day93.
Anemia blood test
Change from baseline anemia blood at Day 0, Day 31 and Day93.
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
control groupNO_INTERVENTIONwith traditional western medicine treatment based on underlined disease
PHY606EXPERIMENTALPHY606 7.5gm BID for 3 months
Healthy groupOTHERPHY606 7.5gm BID for 2 days
Interventions
NameTypeDescription
PHY606DRUGDanggui Buxue Tang is a well-known TCM formula indicated for anemia through immune modulation and increase energy metabolism
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Eligibility Criteria
Age Range20 Years — 90 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * female: Hb\<11 g/dL; male: Hb\<13.5 g/dL * has no allergic reaction to TCM Exclusion Criteria: * below 20 years old * ever drug abuse or still in drug abuse * pregnant or in breast-feeding women * with psychotic disorders * cardiac arrhythmia with pacemaker * dyscoagulation ...

Countries:Taiwan
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