Created at Source Raw Value Validated value
June 25, 2024, noon usa

1. subjects unable or unwilling to give written informed consent and/or to comply with study procedures. 2. any known hypersensitivity or contraindication to cnis, especially csa, or components of any cyclosporine drug product. 3. current or medical history of: * congenital immunodeficiency. * severe, known, active viral infections, excluding sars-cov-2, within 3 months of baseline (e.g., cytomegalovirus, hepatitis b virus, hepatitis c virus or hiv) that are deemed to interfere with study assessments or outcome according to investigator's judgement. 4. severe symptoms resulting from sars-cov-2 infection defined by requiring admittance to a medium or high care unit with the need for positive pressure ventilation at baseline. 5. other major physical or psychiatric illness or major traumatic injury or any other medical condition associated with increased risk to the subject or that may affect study conduct or interfere with study assessments or outcome according to investigator's judgement. 6. subjects who are pregnant, breast feeding or, if of childbearing potential, not using adequate contraceptive precautions. 7. participation in another interventional clinical study within 4 weeks prior to baseline and/or receipt of investigational drugs within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to baseline. 8. subjects less than 3 months post-transplant. 9. subjects with documented organ rejection within the past 3 months. 10. subjects with a documented estimated glomerular filtration rate (egfr) \<15 ml/min within the previous 3 months prior to screening.

1. subjects unable or unwilling to give written informed consent and/or to comply with study procedures. 2. any known hypersensitivity or contraindication to cnis, especially csa, or components of any cyclosporine drug product. 3. current or medical history of: * congenital immunodeficiency. * severe, known, active viral infections, excluding sars-cov-2, within 3 months of baseline (e.g., cytomegalovirus, hepatitis b virus, hepatitis c virus or hiv) that are deemed to interfere with study assessments or outcome according to investigator's judgement. 4. severe symptoms resulting from sars-cov-2 infection defined by requiring admittance to a medium or high care unit with the need for positive pressure ventilation at baseline. 5. other major physical or psychiatric illness or major traumatic injury or any other medical condition associated with increased risk to the subject or that may affect study conduct or interfere with study assessments or outcome according to investigator's judgement. 6. subjects who are pregnant, breast feeding or, if of childbearing potential, not using adequate contraceptive precautions. 7. participation in another interventional clinical study within 4 weeks prior to baseline and/or receipt of investigational drugs within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to baseline. 8. subjects less than 3 months post-transplant. 9. subjects with documented organ rejection within the past 3 months. 10. subjects with a documented estimated glomerular filtration rate (egfr) \<15 ml/min within the previous 3 months prior to screening.

Nov. 16, 2021, 6:30 p.m. usa

subjects unable or unwilling to give written informed consent and/or to comply with study procedures. any known hypersensitivity or contraindication to cnis, especially csa, or components of any cyclosporine drug product. current or medical history of: congenital immunodeficiency. severe, known, active viral infections, excluding sars-cov-2, within 3 months of baseline (e.g., cytomegalovirus, hepatitis b virus, hepatitis c virus or hiv) that are deemed to interfere with study assessments or outcome according to investigator's judgement. severe symptoms resulting from sars-cov-2 infection defined by requiring admittance to a medium or high care unit with the need for positive pressure ventilation at baseline. other major physical or psychiatric illness or major traumatic injury or any other medical condition associated with increased risk to the subject or that may affect study conduct or interfere with study assessments or outcome according to investigator's judgement. subjects who are pregnant, breast feeding or, if of childbearing potential, not using adequate contraceptive precautions. participation in another interventional clinical study within 4 weeks prior to baseline and/or receipt of investigational drugs within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to baseline. subjects less than 3 months post-transplant. subjects with documented organ rejection within the past 3 months. subjects with a documented estimated glomerular filtration rate (egfr) <15 ml/min within the previous 3 months prior to screening.

subjects unable or unwilling to give written informed consent and/or to comply with study procedures. any known hypersensitivity or contraindication to cnis, especially csa, or components of any cyclosporine drug product. current or medical history of: congenital immunodeficiency. severe, known, active viral infections, excluding sars-cov-2, within 3 months of baseline (e.g., cytomegalovirus, hepatitis b virus, hepatitis c virus or hiv) that are deemed to interfere with study assessments or outcome according to investigator's judgement. severe symptoms resulting from sars-cov-2 infection defined by requiring admittance to a medium or high care unit with the need for positive pressure ventilation at baseline. other major physical or psychiatric illness or major traumatic injury or any other medical condition associated with increased risk to the subject or that may affect study conduct or interfere with study assessments or outcome according to investigator's judgement. subjects who are pregnant, breast feeding or, if of childbearing potential, not using adequate contraceptive precautions. participation in another interventional clinical study within 4 weeks prior to baseline and/or receipt of investigational drugs within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to baseline. subjects less than 3 months post-transplant. subjects with documented organ rejection within the past 3 months. subjects with a documented estimated glomerular filtration rate (egfr) <15 ml/min within the previous 3 months prior to screening.

Jan. 10, 2021, 12:31 a.m. usa

1. subjects unable or unwilling to give written informed consent and/or to comply with study procedures. 2. any known hypersensitivity or contraindication to cnis, especially csa, or components of any cyclosporine drug product. 3. current or medical history of: - congenital immunodeficiency. - severe, known, active viral infections, excluding sars-cov-2, within 3 months of baseline (e.g., cytomegalovirus, hepatitis b virus, hepatitis c virus or hiv) that are deemed to interfere with study assessments or outcome according to investigator's judgement. 4. severe symptoms resulting from sars-cov-2 infection defined by requiring admittance to a medium or high care unit with the need for positive pressure ventilation at baseline. 5. other major physical or psychiatric illness or major traumatic injury or any other medical condition associated with increased risk to the subject or that may affect study conduct or interfere with study assessments or outcome according to investigator's judgement. 6. subjects who are pregnant, breast feeding or, if of childbearing potential, not using adequate contraceptive precautions. 7. participation in another interventional clinical study within 4 weeks prior to baseline and/or receipt of investigational drugs within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to baseline. 8. subjects less than 3 months post-transplant. 9. subjects with documented organ rejection within the past 3 months. 10. subjects with a documented estimated glomerular filtration rate (egfr) <15 ml/min within the previous 3 months prior to screening.

1. subjects unable or unwilling to give written informed consent and/or to comply with study procedures. 2. any known hypersensitivity or contraindication to cnis, especially csa, or components of any cyclosporine drug product. 3. current or medical history of: - congenital immunodeficiency. - severe, known, active viral infections, excluding sars-cov-2, within 3 months of baseline (e.g., cytomegalovirus, hepatitis b virus, hepatitis c virus or hiv) that are deemed to interfere with study assessments or outcome according to investigator's judgement. 4. severe symptoms resulting from sars-cov-2 infection defined by requiring admittance to a medium or high care unit with the need for positive pressure ventilation at baseline. 5. other major physical or psychiatric illness or major traumatic injury or any other medical condition associated with increased risk to the subject or that may affect study conduct or interfere with study assessments or outcome according to investigator's judgement. 6. subjects who are pregnant, breast feeding or, if of childbearing potential, not using adequate contraceptive precautions. 7. participation in another interventional clinical study within 4 weeks prior to baseline and/or receipt of investigational drugs within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to baseline. 8. subjects less than 3 months post-transplant. 9. subjects with documented organ rejection within the past 3 months. 10. subjects with a documented estimated glomerular filtration rate (egfr) <15 ml/min within the previous 3 months prior to screening.