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chlorproguanil-dapsone-artesunate

Phase 3

Malaria, Falciparum | Small molecule | Infectious Disease |GSK plc|Last Updated: Dec 5, 2016

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-BlindUNCONTROLLEDBiomarker
Total Trials2
Total Enrollment2,295
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00344006Chlorproguanil-Dapsone-Artesunate Versus COARTEM For Uncomplicated MalariaPHASE3 COMPLETED 1,395 — — Jun 1, 2006Aug 1, 2007Dec 5, 20169 Burkina Faso, Ghana +3
NCT00371735Chlorproguanil-Dapsone-Artesunate (CDA) Versus Chlorproguanil-Dapsone (LAPDAP) For Uncomplicated MalariaPHASE3 COMPLETED 900 — — Apr 1, 2006May 1, 2007Dec 5, 20167 Burkina Faso, Ghana +2
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Study Endpoints
Primary Endpoints
Parasitological cure rate, PCR corrected, at day 28 in the PP population The ITT population is a key supportive analysis.
Parasitological cure rate, PCR-corrected, at day 28, in the per-protocol population. Parasitological cure rate is defined as the clearance of the initial malaria infection by day 7 and remaining free of this infection to the day of assessment.
Secondary Endpoints
Parasitological cure rate, PCR-corrected, at day 14 and 42 ACPR, and ACPR PCR corrected at day 14, 28 and 42 Summary of asexual parasite densities on days 0, 1, 2, 3, 7, 14, 28 and 42 by treatment group.
The proportion of subjects with parasites remaining at 24 hours post-first dose by treatment group. Parasitological cure rate, PCR-corrected, at day 14, by treatment group.
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Arm 1EXPERIMENTAL -
Interventions
NameTypeDescription
chlorproguanil-dapsone-artesunateDRUG -
artemether-lumefantrineDRUG -
chlorproguanil-dapsoneDRUG -
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Eligibility Criteria
Age Range12 Months — 14 Years
SexALL
Healthy VolunteersNo
Study Sites9

Inclusion criteria: * Acute, uncomplicated P.falciparum malaria, microscopically confirmed * Temperature at screening of 37.5oC or or more or confirmed history of fever within previous 24 hours * Weigh 7.5kg or over * Screening haemoglobin (Hb) of 7g/dl or over, or haematocrit of 25% or more(If Hb ...

Countries:Burkina FasoGhanaKenyaNigeriaTanzaniaMali
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