Created at Source Raw Value Validated value
Oct. 14, 2021, 1:55 p.m. eu

1. Patient known to have intolerance or hypersensitivity to chloroquine or any quinoline derivates (quinine, chloroquine, tafenoquine, hydroxychloroquine, mefloquine). 2. Patient requires the use of one of the following forbidden treatment during the study treatment period: Major surgery. Live vaccines. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever and BCG. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed, however intranasal influenza vaccines (Flu-Mist®) are live attenuated vaccines, and are not allowed. 3. Any clinically significant cardiovascular condition as judged by the Investigator, like uncontrolled blood pressure, unstable angina, history of myocardial infraction within 6 months, clinically significant peripheral vascular disease 4. Known hepatitis B, treated or not, with viral load < 20 UI/mL or Human Immunodeficiency Virus (HIV) infection, with negative viral load and CD4 > 250/mm3, in last 3 months. 5. Prior allogeneic bone marrow transplantation or solid organ transplant in the past. 6. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject’s participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating Investigator. 7. Pregnant or breastfeeding patient, or expecting to conceive children within the projected duration of the trial, starting with the screening visit through 6 months after the last dose of study drugs.

1. Patient known to have intolerance or hypersensitivity to chloroquine or any quinoline derivates (quinine, chloroquine, tafenoquine, hydroxychloroquine, mefloquine). 2. Patient requires the use of one of the following forbidden treatment during the study treatment period: Major surgery. Live vaccines. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever and BCG. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed, however intranasal influenza vaccines (Flu-Mist®) are live attenuated vaccines, and are not allowed. 3. Any clinically significant cardiovascular condition as judged by the Investigator, like uncontrolled blood pressure, unstable angina, history of myocardial infraction within 6 months, clinically significant peripheral vascular disease 4. Known hepatitis B, treated or not, with viral load < 20 UI/mL or Human Immunodeficiency Virus (HIV) infection, with negative viral load and CD4 > 250/mm3, in last 3 months. 5. Prior allogeneic bone marrow transplantation or solid organ transplant in the past. 6. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject’s participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating Investigator. 7. Pregnant or breastfeeding patient, or expecting to conceive children within the projected duration of the trial, starting with the screening visit through 6 months after the last dose of study drugs.