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Generated: March 24, 2019

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CLINICAL TRIALS PROFILE FOR CHLOROQUINE PHOSPHATE; PRIMAQUINE PHOSPHATE

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Clinical Trials for Chloroquine Phosphate; Primaquine Phosphate

Trial ID Title Status Sponsor Phase Summary
NCT00158587 Eight Week Primaquine Regimen for the Treatment of Vivax Malaria Completed HealthNet TPO Phase 3 Plasmodium vivax represents a major health problem throughout the tropics. Outside Africa it accounts for over 50% of cases, affecting an estimated 70-80 million people per year. A substantial proportion of clinical cases are not caused by infective bites of Anopheles spp, but by activation of latent hypnozoites in the liver. These relapses may significantly impede development since each illness may result in 5-15 days of absence from work or school. Primaquine(PQ) is the only drug available that eliminates hypnozoites, though its use is beset by clinical problems; it may precipitate haemolytic anaemia in individuals deficient in the blood enzyme glucose 6 phosphate dehydrogenase (G6PD). Without affordable G6PD testing, primaquine use is precluded. Evidence suggests, however, that a course of 8 weekly doses may be a safe and effective alternative to the traditional 14 day course of the drug. The aim of the proposed study, therefore, is to test whether 8 weekly doses of primaquine is as effective as the 14 day course at preventing relapse malaria, without the risk of hemolysis in G6PD deficient individuals.
NCT00158587 Eight Week Primaquine Regimen for the Treatment of Vivax Malaria Completed Gates Malaria Partnership Phase 3 Plasmodium vivax represents a major health problem throughout the tropics. Outside Africa it accounts for over 50% of cases, affecting an estimated 70-80 million people per year. A substantial proportion of clinical cases are not caused by infective bites of Anopheles spp, but by activation of latent hypnozoites in the liver. These relapses may significantly impede development since each illness may result in 5-15 days of absence from work or school. Primaquine(PQ) is the only drug available that eliminates hypnozoites, though its use is beset by clinical problems; it may precipitate haemolytic anaemia in individuals deficient in the blood enzyme glucose 6 phosphate dehydrogenase (G6PD). Without affordable G6PD testing, primaquine use is precluded. Evidence suggests, however, that a course of 8 weekly doses may be a safe and effective alternative to the traditional 14 day course of the drug. The aim of the proposed study, therefore, is to test whether 8 weekly doses of primaquine is as effective as the 14 day course at preventing relapse malaria, without the risk of hemolysis in G6PD deficient individuals.
NCT01205178 G6PD (Glucose-6-phosphate Dehydrogenase) Study to Evaluate Hemolysis Potential of TFQ (Tafenoquine) Completed Medicines for Malaria Venture Phase 1 SB-252263 (Tafenoquine, TQ) is an 8-aminoquinoline (8-AQ) antimalarial drug being developed by GlaxoSmithKline (GSK), the U.S. Army Medical Research and Materiel Command (USAMRMC) and Medicines for Malaria Venture (MMV). TQ is currently being developed for the radical cure of acute P. vivax malaria in combination with standard doses of CQ, which is 1500 mg over 3 days. The current gold standard for radical cure of P. vivax malaria in many areas of the world is chloroquine (CQ) for clearance of the acute parasitemia immediately followed by primaquine (PQ) to clear the liver stages of the parasite and prevent disease relapse. The 8-AQ class of drugs, including PQ, is hemolytic in subjects with glucose-6-phosphate dehydrogenase (G6PD) deficiency. The current study will identify a dose of TQ within the target efficacious dose range that has a hemolytic effect similar to or less than PQ 15 mg OD x 14 days (i.e. ≤ 25-30% hemoglobin decline in WHO class III G6PD-deficient subjects).
NCT01205178 G6PD (Glucose-6-phosphate Dehydrogenase) Study to Evaluate Hemolysis Potential of TFQ (Tafenoquine) Completed GlaxoSmithKline Phase 1 SB-252263 (Tafenoquine, TQ) is an 8-aminoquinoline (8-AQ) antimalarial drug being developed by GlaxoSmithKline (GSK), the U.S. Army Medical Research and Materiel Command (USAMRMC) and Medicines for Malaria Venture (MMV). TQ is currently being developed for the radical cure of acute P. vivax malaria in combination with standard doses of CQ, which is 1500 mg over 3 days. The current gold standard for radical cure of P. vivax malaria in many areas of the world is chloroquine (CQ) for clearance of the acute parasitemia immediately followed by primaquine (PQ) to clear the liver stages of the parasite and prevent disease relapse. The 8-AQ class of drugs, including PQ, is hemolytic in subjects with glucose-6-phosphate dehydrogenase (G6PD) deficiency. The current study will identify a dose of TQ within the target efficacious dose range that has a hemolytic effect similar to or less than PQ 15 mg OD x 14 days (i.e. ≤ 25-30% hemoglobin decline in WHO class III G6PD-deficient subjects).
NCT01218932 Pharmacokinetic Study of Primaquine and Chloroquine in Healthy Subjects Completed Mahidol University Phase 1 This is a standard pharmacokinetic interaction study. Subjects will be randomized to be either group A or B. Group A. Subjects will have 3 hospitalizations to complete. Each hospitalization will be about 12-24 hours depends on each regimen. Subjects in A group who receive regimen 1 of primaquine (PQ) on the first admission (visit 2) will receive regimen 2 of primaquine and chloroquine combination (PQ and CQ) on second admission (visit 3) after 1 week wash out period and will finish with regimen 3 of Chloroquine (CQ) on the third admission (visit 4) after 8 weeks wash out period. Subjects in B group who receive regimen 1 of primaquine (PQ) will receive regimen 2 of chloroquine (CQ) on second admission (visit 3) after 1 week wash out period and regimen 3 of primaquine and chloroquine combination (PQ and CQ)on third admission(visit 4) with 8 week wash out period in between.
NCT01218932 Pharmacokinetic Study of Primaquine and Chloroquine in Healthy Subjects Completed University of Oxford Phase 1 This is a standard pharmacokinetic interaction study. Subjects will be randomized to be either group A or B. Group A. Subjects will have 3 hospitalizations to complete. Each hospitalization will be about 12-24 hours depends on each regimen. Subjects in A group who receive regimen 1 of primaquine (PQ) on the first admission (visit 2) will receive regimen 2 of primaquine and chloroquine combination (PQ and CQ) on second admission (visit 3) after 1 week wash out period and will finish with regimen 3 of Chloroquine (CQ) on the third admission (visit 4) after 8 weeks wash out period. Subjects in B group who receive regimen 1 of primaquine (PQ) will receive regimen 2 of chloroquine (CQ) on second admission (visit 3) after 1 week wash out period and regimen 3 of primaquine and chloroquine combination (PQ and CQ)on third admission(visit 4) with 8 week wash out period in between.
NCT01288820 Study of ACTs Plus Primaquine for Uncomplicated Plasmodium Vivax Malaria Completed Mahidol University Phase 3 This randomized clinical trial will be conducted in subjects with uncomplicated Plasmodium vivax malaria during November 2010 to March 2012. The aim of the study is to compare the efficacy and safety of artesunate-amodiaquine plus primaquine (AS-AQ + PQ) and dihydroartemisinin-piperaquine plus primaquine (DHP + PQ) in uncomplicated vivax malaria. The significance of the study is to find alternative drug for treating patients with vivax malaria in case the standard treatment is not available or become resistance. This study will give thorough information about the efficacy and safety of 2 artemisinin-based combination therapies (ACTs) in combination with primaquine. It will also inform the Indonesian Ministry of Health on their suggested policies for radical cure of vivax malaria, and provides evidence based treatment options for chloroquine resistant vivax malaria. This study will also provide information about prevalence of glucose-6-phosphate dehydrogenase (G6PD) deficiency and G6PD variants in North Sumatera population.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Chloroquine Phosphate; Primaquine Phosphate

Condition Name

Condition Name for Chloroquine Phosphate; Primaquine Phosphate
Intervention Trials
Malaria 5
Vivax Malaria 4
Malaria, Vivax 3
Healthy 3
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Condition MeSH

Condition MeSH for Chloroquine Phosphate; Primaquine Phosphate
Intervention Trials
Malaria 11
Malaria, Vivax 8
Glucosephosphate Dehydrogenase Deficiency 2
Hemolysis 1
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Clinical Trial Locations for Chloroquine Phosphate; Primaquine Phosphate

Trials by Country

Trials by Country for Chloroquine Phosphate; Primaquine Phosphate
Location Trials
Thailand 6
Indonesia 3
Brazil 3
Vietnam 2
Ethiopia 2
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Clinical Trial Progress for Chloroquine Phosphate; Primaquine Phosphate

Clinical Trial Phase

Clinical Trial Phase for Chloroquine Phosphate; Primaquine Phosphate
Clinical Trial Phase Trials
Phase 4 4
Phase 3 4
Phase 2 2
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Clinical Trial Status

Clinical Trial Status for Chloroquine Phosphate; Primaquine Phosphate
Clinical Trial Phase Trials
Completed 8
Recruiting 5
Not yet recruiting 2
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Clinical Trial Sponsors for Chloroquine Phosphate; Primaquine Phosphate

Sponsor Name

Sponsor Name for Chloroquine Phosphate; Primaquine Phosphate
Sponsor Trials
University of Oxford 6
GlaxoSmithKline 3
Medicines for Malaria Venture 3
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Sponsor Type

Sponsor Type for Chloroquine Phosphate; Primaquine Phosphate
Sponsor Trials
Other 31
Industry 3
U.S. Fed 1
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