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Last Updated: October 12, 2024

CLINICAL TRIALS PROFILE FOR CHLOROQUINE HYDROCHLORIDE


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505(b)(2) Clinical Trials for Chloroquine Hydrochloride

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Formulation NCT05788094 ↗ DHA-PPQ vs CHQ With Tafenoquine for P. Vivax Mono-infection Not yet recruiting Mahidol Oxford Tropical Medicine Research Unit Phase 4 2023-04-01 In this area of Greater Mekong Subregion (GMS), vivax malaria is the most common kind of malaria. It can stay very long in the liver, and come out later to make another episode of illness. This can happen many times even without a mosquito bite. Only 8-aminoquinoline drugs can kill the liver forms of the malaria parasite. One of these drugs is called primaquine, and it has been used all over the world for a long time. There is now a new formulation of this 8-aminoquinoline drug called tafenoquine that can also treat the malaria in the liver. The main benefit of this drug is that it is a single dose, which makes much convenient for the patients as well as for the malaria control program than conventional 14 days of primaquine. Recent research suggests that ACT (Artemisinin Combination Therapy) may antagonise the efficacy of tafenoquine (Baird et al. 2020) . This could prevent the use of tafenoquine in areas with chloroquine resistant P. vivax parasites where national malaria programmes recommend ACTs for vivax malaria. Also, currently recommended tafenoquine dose is sub-optimal: 300 mg dose proved significantly inferior to low dose primaquine in a meta-analysis of the phase 3 studies when restricted to the Southeast Asian region (Llanos-Cuentas et al. 2019; Watson et al. 2022). A tafenoquine dose of 450mg is predicted to provide >90% of the maximal effect. The objective of this research is to find out whether 450 mg dose of tafenoquine can be combined effectively with ACT providing a short course treatment for P. vivax malaria.
New Formulation NCT05788094 ↗ DHA-PPQ vs CHQ With Tafenoquine for P. Vivax Mono-infection Not yet recruiting Shoklo Malaria Research Unit Phase 4 2023-04-01 In this area of Greater Mekong Subregion (GMS), vivax malaria is the most common kind of malaria. It can stay very long in the liver, and come out later to make another episode of illness. This can happen many times even without a mosquito bite. Only 8-aminoquinoline drugs can kill the liver forms of the malaria parasite. One of these drugs is called primaquine, and it has been used all over the world for a long time. There is now a new formulation of this 8-aminoquinoline drug called tafenoquine that can also treat the malaria in the liver. The main benefit of this drug is that it is a single dose, which makes much convenient for the patients as well as for the malaria control program than conventional 14 days of primaquine. Recent research suggests that ACT (Artemisinin Combination Therapy) may antagonise the efficacy of tafenoquine (Baird et al. 2020) . This could prevent the use of tafenoquine in areas with chloroquine resistant P. vivax parasites where national malaria programmes recommend ACTs for vivax malaria. Also, currently recommended tafenoquine dose is sub-optimal: 300 mg dose proved significantly inferior to low dose primaquine in a meta-analysis of the phase 3 studies when restricted to the Southeast Asian region (Llanos-Cuentas et al. 2019; Watson et al. 2022). A tafenoquine dose of 450mg is predicted to provide >90% of the maximal effect. The objective of this research is to find out whether 450 mg dose of tafenoquine can be combined effectively with ACT providing a short course treatment for P. vivax malaria.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Chloroquine Hydrochloride

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00074841 ↗ Trial of Azithromycin Plus Chloroquine Versus Sulfadoxine-Pyrimethamine Plus Chloroquine for the Treatment of Uncomplicated Malaria in India Completed Pfizer Phase 2/Phase 3 2003-09-01 This primary objective of this study is to assess whether the combination of Azithromycin with chloroquine is non-inferior to the combination of sulfadoxine-pyrimethamine plus chloroquine, when used to treat uncomplicated cases of malaria due to Plasmodium falciparum in adults in India.
NCT00082563 ↗ Azithromycin in Combination With Chloroquine Versus Chloroquine in the Eradication of Asymptomatic Plasmodium Falciparum Terminated Pfizer Phase 2 2004-08-01 The purpose of this study is to determine if Azithromycin in combination with chloroquine is superior to chloroquine alone in eradicating P. falciparum asexual parasitemia in asymptomatic, semi-immune adults in Western Kenya.
NCT00082576 ↗ Azithromycin Plus Chloroquine Versus Mefloquine for the Treatment of Uncomplicated Malaria in Africa Completed Pfizer Phase 2/Phase 3 2004-06-01 The primary objective is to confirm the hypothesis that azithromycin plus chloroquine is non-inferior to mefloquine for the treatment of symptomatic, uncomplicated malaria due to P. falciparum.
NCT00084227 ↗ Azithromycin Plus Chloroquine Versus Atovaquone-Proguanil For The Treatment Of Uncomplicated Plasmodium Falciparum Malaria In South America Completed Pfizer Phase 2/Phase 3 2004-07-01 The primary objective is to confirm the hypothesis that azithromycin plus chloroquine is non-inferior to atovaquone-proguanil for the treatment of symptomatic, uncomplicated malaria due to P. falciparum.
NCT00084240 ↗ Azithromycin Plus Chloroquine Versus Sulfadoxine-Pyrimethamine Plus Chloroquine For The Treatment Of Uncomplicated, Symptomatic Falciparum Malaria In Southeast Asia Terminated Pfizer Phase 2/Phase 3 2004-03-01 The primary objective is to confirm the hypothesis that azithromycin (optimal dose once daily for three days) plus chloroquine is non-inferior to sulfadoxine-pyrimethamine plus chloroquine for the treatment of uncomplicated, symptomatic malaria due to P. falciparum.
NCT00118807 ↗ Trial of the Effectiveness of AQ/AS, SP/AQ and SP/CQ for Uncomplicated Malaria in Gambian Children Completed Medical Research Council Phase 3 2003-08-01 The purpose of this trial is to compare the effectiveness of three combination treatments for uncomplicated malaria when given in operational settings, without supervision of doses other than the first dose.
NCT00118807 ↗ Trial of the Effectiveness of AQ/AS, SP/AQ and SP/CQ for Uncomplicated Malaria in Gambian Children Completed National Malaria Control Programme, The Gambia Phase 3 2003-08-01 The purpose of this trial is to compare the effectiveness of three combination treatments for uncomplicated malaria when given in operational settings, without supervision of doses other than the first dose.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Chloroquine Hydrochloride

Condition Name

Condition Name for Chloroquine Hydrochloride
Intervention Trials
Malaria 69
COVID-19 50
Vivax Malaria 19
Malaria, Vivax 15
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Condition MeSH

Condition MeSH for Chloroquine Hydrochloride
Intervention Trials
Malaria 145
COVID-19 86
Malaria, Vivax 44
Malaria, Falciparum 40
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Clinical Trial Locations for Chloroquine Hydrochloride

Trials by Country

Trials by Country for Chloroquine Hydrochloride
Location Trials
United States 59
Brazil 57
Spain 21
Thailand 19
India 19
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Trials by US State

Trials by US State for Chloroquine Hydrochloride
Location Trials
New York 10
Maryland 7
Missouri 5
Connecticut 3
Ohio 3
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Clinical Trial Progress for Chloroquine Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Chloroquine Hydrochloride
Clinical Trial Phase Trials
Phase 4 60
Phase 3 74
Phase 2/Phase 3 33
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Clinical Trial Status

Clinical Trial Status for Chloroquine Hydrochloride
Clinical Trial Phase Trials
Completed 181
Not yet recruiting 35
Terminated 31
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Clinical Trial Sponsors for Chloroquine Hydrochloride

Sponsor Name

Sponsor Name for Chloroquine Hydrochloride
Sponsor Trials
London School of Hygiene and Tropical Medicine 25
University of Oxford 19
National Institute of Allergy and Infectious Diseases (NIAID) 14
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Sponsor Type

Sponsor Type for Chloroquine Hydrochloride
Sponsor Trials
Other 607
Industry 56
U.S. Fed 28
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