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Chlorproguanil-dapsone-artesunate

Phase 4

Malaria, Falciparum | Small molecule | Infectious Disease |GSK plc|Trials Updated: Dec 6, 2016

Chlorproguanil-dapsone-artesunate development status

Highest phase Phase 4 run by Novartis Pharmaceuticals (NCT00386750)
Phase scored for GSKPhase 3
Registered trials 8 across 4 sponsors since Jun 2006

Chlorproguanil-dapsone-artesunate target and mechanism

ModalitySmall molecule

Also known as Chlorproguanil-dapsone-artesunate (CDA), artemether-lumefantrine, chlorproguanil-dapsone

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials3
Total Enrollment2,415

FDA Designations

No designations recorded

Chlorproguanil-dapsone-artesunate clinical trials

Chlorproguanil-dapsone-artesunate · 3 trials · 2 indications

Phase 3 2Phase 2 1
NCT00344006Chlorproguanil-Dapsone-Artesunate Versus COARTEM For Uncomplicated MalariaMalaria, Falciparum
COMPLETED1,395 Analytics
NCT00371735Chlorproguanil-Dapsone-Artesunate (CDA) Versus Chlorproguanil-Dapsone (LAPDAP) For Uncomplicated MalariaMalaria, Falciparum
COMPLETED900 Analytics
PHASE3COMPLETED
Chlorproguanil-Dapsone-Artesunate Versus COARTEM For Uncomplicated Malaria
Malaria, FalciparumUnlock trial analytics
PHASE3COMPLETED
Chlorproguanil-Dapsone-Artesunate (CDA) Versus Chlorproguanil-Dapsone (LAPDAP) For Uncomplicated Malaria
Malaria, FalciparumUnlock trial analytics

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.
Treatment differences between 1,2, or 4mg/kg artesunate with a fixed dose of Chlorproguanil-dapsone (LAPDAP), as measured by determination of PC90 (time to achieve reduction of parasitaemia by 90% of baseline)

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.
The key secondary efficacy endpoint is parasite viability (the proportion of ring-form parasites developing to schizonts) determined from rich adult data and confirmed with more sparse child data
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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 -
Chlorproguanil-dapsone-artesunate (CDA)DRUG -
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Eligibility Criteria

Age Range12 Months to 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 FasoGhanaKenyaNigeriaTanzaniaMaliMalawiThe Gambia
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Frequently asked questions about Chlorproguanil-dapsone-artesunate

What is chlorproguanil-dapsone-artesunate used for?

Chlorproguanil-dapsone-artesunate is an investigational combination therapy developed for the treatment of uncomplicated Plasmodium falciparum malaria. It combines three antimalarial agents in a single regimen. It is not approved and remains in clinical development. Studies enrolled adults and children, including children as young as 12 months, in African countries where falciparum malaria is endemic.

Who is developing chlorproguanil-dapsone-artesunate?

Chlorproguanil-dapsone-artesunate is developed by GSK plc, which trades under the ticker GSK. The company sponsored the clinical trial program evaluating the combination for uncomplicated falciparum malaria in Africa. The program includes studies conducted in Malawi, The Gambia, Burkina Faso, Ghana, Mali, Nigeria, Kenya, and Tanzania.

What phase is chlorproguanil-dapsone-artesunate in?

Chlorproguanil-dapsone-artesunate is in Phase 2 development. It is an investigational product and is not approved for any indication. The clinical program includes a Phase 2 trial and two Phase 3 trials, all of which are completed. No trials are currently active.

What clinical trials is chlorproguanil-dapsone-artesunate in?

Chlorproguanil-dapsone-artesunate has been studied in three completed trials: NCT00519467, a Phase 2 safety and efficacy study of artesunate combined with LAPDAP in Malawi and The Gambia; NCT00371735, a Phase 3 comparison against chlorproguanil-dapsone (LAPDAP) in Burkina Faso, Ghana, Mali, and Nigeria; and NCT00344006, a Phase 3 comparison against COARTEM in Burkina Faso, Ghana, Kenya, Nigeria, and Tanzania.

Is chlorproguanil-dapsone-artesunate the same as CDA?

Yes. Chlorproguanil-dapsone-artesunate is also known as CDA, an abbreviation formed from the three components of the combination. The same asset appears in the literature and in trial records under both the full name and the CDA abbreviation, including the Phase 3 trial NCT00371735, which is titled using the CDA name.

How many patients were studied with chlorproguanil-dapsone-artesunate?

Across its completed clinical trials, chlorproguanil-dapsone-artesunate has been studied in approximately 2,295 participants. The Phase 2 trial NCT00519467 enrolled 120 participants, while the two Phase 3 trials, NCT00371735 and NCT00344006, enrolled 900 and 1,395 participants respectively. The trials were randomized and enrolled both adults and children.