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DHA-PQ

Phase 2

Malaria | Small molecule | Infectious Disease |Co-Diagnostics, Inc.|Last Updated: Mar 21, 2011

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
RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment1,500
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00941785Dihydroartemisinin (DHA)-Piperaquine for IPT to Prevent Malaria in Children in Burkina FasoPHASE2 COMPLETED 1,500Jul 1, 2009Dec 1, 2009Mar 21, 20111 Burkina Faso
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Study Endpoints
Primary Endpoints
Efficacy against clinical malaria
August to December 2009
Incidence of adverse events
Within 7 days of each treatment round and within 1 month of treatment
Secondary Endpoints
Pharmacokinetics of piperaquie: the oral clearance (CL/F), AUC, steady state volume of distribution(s) (Vss/F), inter-compartment clearance(s) (Q/F) and absorption rate (ka) will be estimated.
during 30 days after start of treatment
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
DHA-PQEXPERIMENTALThree monthly administrations of dihydroartemisinin (DHA) plus piperaquine (PQ) in August, September and October.
SP-AQACTIVE_COMPARATORThree monthly administrations of sulfadoxine-pyrimethamine plus amodiaquine
Interventions
NameTypeDescription
DHA-PQDRUGThree monthly administrations of Duocotexcin (DHA-PQ): dihydroartemisinin 2.1mg/kg and piperaquine phosphate 16.8 mg/kg once daily for three days
SP-AQDRUGThree monthly administrations of sulfadoxine-pyrimethamine plus amodiaquine: One dose of Sulfadoxine 25mg/kg and pyrimethamine 1.25mg/kg Three daily doses of amodiaquine phosphate 10mg/kg
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Eligibility Criteria
Age Range3 Months — 59 Months
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * signed consent from a parent * age 3-59 months at enrolment * no history of allergy to study drugs * no chronic illness Exclusion Criteria: * history of allergy to study drugs * intention to move away from the study area before the end of 2009 * any chronic illness

Countries:Burkina Faso
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Competitive Landscape -Malaria 8 trials