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Generated: December 14, 2018

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CLINICAL TRIALS PROFILE FOR PRIMAQUINE PHOSPHATE

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Clinical Trials for 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.
NCT01178021 Estimating the Risk of Plasmodium Vivax Relapses in Afghanistan Unknown status Mahidol University Phase 4 This is an open label two-arm randomized prospective study of two treatments for P. vivax malaria. Patients meeting study inclusion criteria will be enrolled and allocated either chloroquine alone or chloroquine plus primaquine (0.25mg/kg/day for 14 days). Patients will be followed-up for 1 year, with clinical and laboratory examinations at each visit. Patients with recurrent P. vivax infection will be treated with the same medication as initially randomized unless contraindicated. Recurrences in the two arms will be compared to estimate the risk of and mean duration to relapse, classify the relapse pattern as early or late relapse and to estimate the efficacy and safety of the study drugs. Polymerase Chain Reaction (PCR) analysis will be used as far as possible help to distinguish between relapse and re-infection. Samples for chloroquine pharmacokinetic analysis will be collected on day 7 from each study subject as well as on the day of recurrence if within 8 weeks of chloroquine
NCT01178021 Estimating the Risk of Plasmodium Vivax Relapses in Afghanistan Unknown status National Malaria and Leishmaniasis Control Program, Afghanistan Phase 4 This is an open label two-arm randomized prospective study of two treatments for P. vivax malaria. Patients meeting study inclusion criteria will be enrolled and allocated either chloroquine alone or chloroquine plus primaquine (0.25mg/kg/day for 14 days). Patients will be followed-up for 1 year, with clinical and laboratory examinations at each visit. Patients with recurrent P. vivax infection will be treated with the same medication as initially randomized unless contraindicated. Recurrences in the two arms will be compared to estimate the risk of and mean duration to relapse, classify the relapse pattern as early or late relapse and to estimate the efficacy and safety of the study drugs. Polymerase Chain Reaction (PCR) analysis will be used as far as possible help to distinguish between relapse and re-infection. Samples for chloroquine pharmacokinetic analysis will be collected on day 7 from each study subject as well as on the day of recurrence if within 8 weeks of chloroquine
NCT01178021 Estimating the Risk of Plasmodium Vivax Relapses in Afghanistan Unknown status University of Oxford Phase 4 This is an open label two-arm randomized prospective study of two treatments for P. vivax malaria. Patients meeting study inclusion criteria will be enrolled and allocated either chloroquine alone or chloroquine plus primaquine (0.25mg/kg/day for 14 days). Patients will be followed-up for 1 year, with clinical and laboratory examinations at each visit. Patients with recurrent P. vivax infection will be treated with the same medication as initially randomized unless contraindicated. Recurrences in the two arms will be compared to estimate the risk of and mean duration to relapse, classify the relapse pattern as early or late relapse and to estimate the efficacy and safety of the study drugs. Polymerase Chain Reaction (PCR) analysis will be used as far as possible help to distinguish between relapse and re-infection. Samples for chloroquine pharmacokinetic analysis will be collected on day 7 from each study subject as well as on the day of recurrence if within 8 weeks of chloroquine
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).
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Primaquine Phosphate

Condition Name

Condition Name for Primaquine Phosphate
Intervention Trials
Malaria 11
Vivax Malaria 6
Healthy 5
Malaria, Vivax 3
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Condition MeSH

Condition MeSH for Primaquine Phosphate
Intervention Trials
Malaria 21
Malaria, Vivax 10
Glucosephosphate Dehydrogenase Deficiency 4
Recurrence 2
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Clinical Trial Locations for Primaquine Phosphate

Trials by Country

Trials by Country for Primaquine Phosphate
Location Trials
Thailand 9
Afghanistan 4
Indonesia 4
Brazil 3
Vietnam 2
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Clinical Trial Progress for Primaquine Phosphate

Clinical Trial Phase

Clinical Trial Phase for Primaquine Phosphate
Clinical Trial Phase Trials
Phase 4 9
Phase 3 6
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for Primaquine Phosphate
Clinical Trial Phase Trials
Completed 19
Recruiting 6
Not yet recruiting 2
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Clinical Trial Sponsors for Primaquine Phosphate

Sponsor Name

Sponsor Name for Primaquine Phosphate
Sponsor Trials
University of Oxford 11
Mahidol University 4
London School of Hygiene and Tropical Medicine 3
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Sponsor Type

Sponsor Type for Primaquine Phosphate
Sponsor Trials
Other 66
Industry 3
U.S. Fed 2
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