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

1. treatment with interferons (ifns) immunomodulators and/or immunosuppressive or b-cell depleting medications within 12 months before screening. 2. previous use of interferon lambda. patients who previously participated in a clinical trial of interferon lambda but are confirmed to have received placebo or another non-lambda ifns are allowed. 3. history or evidence of any intolerance or hypersensitivity to ifns. 4. patients with respiratory infection requiring invasive or non-invasive ventilatory support (bipap or intubation and mechanical ventilation). 5. participation in a clinical trial with use of any investigational drug within 30 days before screening. 6. history of any of the following diseases or conditions: * advanced or decompensated liver disease (presence or history of bleeding varices, ascites, encephalopathy or hepato-renal syndrome) * immunologically mediated disease (e.g., rheumatoid arthritis, inflammatory bowel disease, severe psoriasis, systemic lupus erythematosus) that requires more than intermittent nonsteroidal anti-inflammatory medications for management or that requires use of systemic corticosteroids in the 6 months before screening (inhaled asthma medications are allowed). * retinal disorder or clinically relevant ophthalmic disorder. * any malignancy within 5 years before screening. exceptions are superficial dermatologic malignancies (e.g., squamous cell or basal cell skin cancer treated with curative intent). * cardiomyopathy, significant ischemic cardiac or cerebrovascular disease (including history of angina, myocardial infarction, or interventional procedure for coronary artery disease), or cardiac rhythm disorder. * chronic pulmonary disease (e.g., chronic obstructive pulmonary disease) associated with functional impairment. * pancreatitis. * severe or uncontrolled psychiatric disorder, e.g., depression, manic condition, psychosis, acute and/or chronic cognitive dysfunction, suicidal behavior, and relapse of substance abuse. * active seizure disorder defined by either an untreated seizure disorder or continued seizure activity within the preceding year despite treatment with anti-seizure medication. * bone marrow or solid organ transplantation * other significant medical condition that may require intervention during the trial (such as uncontrolled diabetes or thyroid disease) patients with any serious condition that, in the opinion of the investigator, would preclude evaluation of response or make it unlikely that the contemplated course of therapy and follow-up could be completed. patients for whom participation in the trial would increase their risk. * current eating disorder * current alcohol abuse (excessive alcohol intake, defined as follows: \>20 g/day for females \[1.5 standard alcohol drinks\] or \>30 g/day for males \[2.0 standard alcohol drinks\]. a standard drink contains 14 g of alcohol: 360 ml of beer, 150 ml of wine, or 45 ml of spirits * drug abuse within the previous 6 months before screening, with the exception of cannabinoids and their derivatives 7. any of the following abnormal laboratory test in the 12 months prior to enrollment * platelet count \<90,000 cells/mm3 * white blood cell (wbc) count \<3,000 cells/mm3 * absolute neutrophil count (anc) \<1,500 cells/mm3 * hemoglobin \<11 g/dl for women and \<12 g/dl for men * estimated creatinine clearance (crcl) \< 50 ml/min by cockroft-gault formulation * alt and/or alt levels \> 10 times the upper limit of normal * bilirubin level ≥ 2.5 mg/dl unless due to gilbert's syndrome * serum albumin level \<3.5 g/dl * international normalized ratio (inr) ≥1.5 (except patients maintained on anticoagulant medications)

1. treatment with interferons (ifns) immunomodulators and/or immunosuppressive or b-cell depleting medications within 12 months before screening. 2. previous use of interferon lambda. patients who previously participated in a clinical trial of interferon lambda but are confirmed to have received placebo or another non-lambda ifns are allowed. 3. history or evidence of any intolerance or hypersensitivity to ifns. 4. patients with respiratory infection requiring invasive or non-invasive ventilatory support (bipap or intubation and mechanical ventilation). 5. participation in a clinical trial with use of any investigational drug within 30 days before screening. 6. history of any of the following diseases or conditions: * advanced or decompensated liver disease (presence or history of bleeding varices, ascites, encephalopathy or hepato-renal syndrome) * immunologically mediated disease (e.g., rheumatoid arthritis, inflammatory bowel disease, severe psoriasis, systemic lupus erythematosus) that requires more than intermittent nonsteroidal anti-inflammatory medications for management or that requires use of systemic corticosteroids in the 6 months before screening (inhaled asthma medications are allowed). * retinal disorder or clinically relevant ophthalmic disorder. * any malignancy within 5 years before screening. exceptions are superficial dermatologic malignancies (e.g., squamous cell or basal cell skin cancer treated with curative intent). * cardiomyopathy, significant ischemic cardiac or cerebrovascular disease (including history of angina, myocardial infarction, or interventional procedure for coronary artery disease), or cardiac rhythm disorder. * chronic pulmonary disease (e.g., chronic obstructive pulmonary disease) associated with functional impairment. * pancreatitis. * severe or uncontrolled psychiatric disorder, e.g., depression, manic condition, psychosis, acute and/or chronic cognitive dysfunction, suicidal behavior, and relapse of substance abuse. * active seizure disorder defined by either an untreated seizure disorder or continued seizure activity within the preceding year despite treatment with anti-seizure medication. * bone marrow or solid organ transplantation * other significant medical condition that may require intervention during the trial (such as uncontrolled diabetes or thyroid disease) patients with any serious condition that, in the opinion of the investigator, would preclude evaluation of response or make it unlikely that the contemplated course of therapy and follow-up could be completed. patients for whom participation in the trial would increase their risk. * current eating disorder * current alcohol abuse (excessive alcohol intake, defined as follows: \>20 g/day for females \[1.5 standard alcohol drinks\] or \>30 g/day for males \[2.0 standard alcohol drinks\]. a standard drink contains 14 g of alcohol: 360 ml of beer, 150 ml of wine, or 45 ml of spirits * drug abuse within the previous 6 months before screening, with the exception of cannabinoids and their derivatives 7. any of the following abnormal laboratory test in the 12 months prior to enrollment * platelet count \<90,000 cells/mm3 * white blood cell (wbc) count \<3,000 cells/mm3 * absolute neutrophil count (anc) \<1,500 cells/mm3 * hemoglobin \<11 g/dl for women and \<12 g/dl for men * estimated creatinine clearance (crcl) \< 50 ml/min by cockroft-gault formulation * alt and/or alt levels \> 10 times the upper limit of normal * bilirubin level ≥ 2.5 mg/dl unless due to gilbert's syndrome * serum albumin level \<3.5 g/dl * international normalized ratio (inr) ≥1.5 (except patients maintained on anticoagulant medications)

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

treatment with interferons (ifns) immunomodulators and/or immunosuppressive or b-cell depleting medications within 12 months before screening. previous use of interferon lambda. patients who previously participated in a clinical trial of interferon lambda but are confirmed to have received placebo or another non-lambda ifns are allowed. history or evidence of any intolerance or hypersensitivity to ifns. patients with respiratory infection requiring invasive or non-invasive ventilatory support (bipap or intubation and mechanical ventilation). participation in a clinical trial with use of any investigational drug within 30 days before screening. history of any of the following diseases or conditions: advanced or decompensated liver disease (presence or history of bleeding varices, ascites, encephalopathy or hepato-renal syndrome) immunologically mediated disease (e.g., rheumatoid arthritis, inflammatory bowel disease, severe psoriasis, systemic lupus erythematosus) that requires more than intermittent nonsteroidal anti-inflammatory medications for management or that requires use of systemic corticosteroids in the 6 months before screening (inhaled asthma medications are allowed). retinal disorder or clinically relevant ophthalmic disorder. any malignancy within 5 years before screening. exceptions are superficial dermatologic malignancies (e.g., squamous cell or basal cell skin cancer treated with curative intent). cardiomyopathy, significant ischemic cardiac or cerebrovascular disease (including history of angina, myocardial infarction, or interventional procedure for coronary artery disease), or cardiac rhythm disorder. chronic pulmonary disease (e.g., chronic obstructive pulmonary disease) associated with functional impairment. pancreatitis. severe or uncontrolled psychiatric disorder, e.g., depression, manic condition, psychosis, acute and/or chronic cognitive dysfunction, suicidal behavior, and relapse of substance abuse. active seizure disorder defined by either an untreated seizure disorder or continued seizure activity within the preceding year despite treatment with anti-seizure medication. bone marrow or solid organ transplantation other significant medical condition that may require intervention during the trial (such as uncontrolled diabetes or thyroid disease) patients with any serious condition that, in the opinion of the investigator, would preclude evaluation of response or make it unlikely that the contemplated course of therapy and follow-up could be completed. patients for whom participation in the trial would increase their risk. current eating disorder current alcohol abuse (excessive alcohol intake, defined as follows: >20 g/day for females [1.5 standard alcohol drinks] or >30 g/day for males [2.0 standard alcohol drinks]. a standard drink contains 14 g of alcohol: 360 ml of beer, 150 ml of wine, or 45 ml of spirits drug abuse within the previous 6 months before screening, with the exception of cannabinoids and their derivatives any of the following abnormal laboratory test in the 12 months prior to enrollment platelet count <90,000 cells/mm3 white blood cell (wbc) count <3,000 cells/mm3 absolute neutrophil count (anc) <1,500 cells/mm3 hemoglobin <11 g/dl for women and <12 g/dl for men estimated creatinine clearance (crcl) < 50 ml/min by cockroft-gault formulation alt and/or alt levels > 10 times the upper limit of normal bilirubin level ≥ 2.5 mg/dl unless due to gilbert's syndrome serum albumin level <3.5 g/dl international normalized ratio (inr) ≥1.5 (except patients maintained on anticoagulant medications)

treatment with interferons (ifns) immunomodulators and/or immunosuppressive or b-cell depleting medications within 12 months before screening. previous use of interferon lambda. patients who previously participated in a clinical trial of interferon lambda but are confirmed to have received placebo or another non-lambda ifns are allowed. history or evidence of any intolerance or hypersensitivity to ifns. patients with respiratory infection requiring invasive or non-invasive ventilatory support (bipap or intubation and mechanical ventilation). participation in a clinical trial with use of any investigational drug within 30 days before screening. history of any of the following diseases or conditions: advanced or decompensated liver disease (presence or history of bleeding varices, ascites, encephalopathy or hepato-renal syndrome) immunologically mediated disease (e.g., rheumatoid arthritis, inflammatory bowel disease, severe psoriasis, systemic lupus erythematosus) that requires more than intermittent nonsteroidal anti-inflammatory medications for management or that requires use of systemic corticosteroids in the 6 months before screening (inhaled asthma medications are allowed). retinal disorder or clinically relevant ophthalmic disorder. any malignancy within 5 years before screening. exceptions are superficial dermatologic malignancies (e.g., squamous cell or basal cell skin cancer treated with curative intent). cardiomyopathy, significant ischemic cardiac or cerebrovascular disease (including history of angina, myocardial infarction, or interventional procedure for coronary artery disease), or cardiac rhythm disorder. chronic pulmonary disease (e.g., chronic obstructive pulmonary disease) associated with functional impairment. pancreatitis. severe or uncontrolled psychiatric disorder, e.g., depression, manic condition, psychosis, acute and/or chronic cognitive dysfunction, suicidal behavior, and relapse of substance abuse. active seizure disorder defined by either an untreated seizure disorder or continued seizure activity within the preceding year despite treatment with anti-seizure medication. bone marrow or solid organ transplantation other significant medical condition that may require intervention during the trial (such as uncontrolled diabetes or thyroid disease) patients with any serious condition that, in the opinion of the investigator, would preclude evaluation of response or make it unlikely that the contemplated course of therapy and follow-up could be completed. patients for whom participation in the trial would increase their risk. current eating disorder current alcohol abuse (excessive alcohol intake, defined as follows: >20 g/day for females [1.5 standard alcohol drinks] or >30 g/day for males [2.0 standard alcohol drinks]. a standard drink contains 14 g of alcohol: 360 ml of beer, 150 ml of wine, or 45 ml of spirits drug abuse within the previous 6 months before screening, with the exception of cannabinoids and their derivatives any of the following abnormal laboratory test in the 12 months prior to enrollment platelet count <90,000 cells/mm3 white blood cell (wbc) count <3,000 cells/mm3 absolute neutrophil count (anc) <1,500 cells/mm3 hemoglobin <11 g/dl for women and <12 g/dl for men estimated creatinine clearance (crcl) < 50 ml/min by cockroft-gault formulation alt and/or alt levels > 10 times the upper limit of normal bilirubin level ≥ 2.5 mg/dl unless due to gilbert's syndrome serum albumin level <3.5 g/dl international normalized ratio (inr) ≥1.5 (except patients maintained on anticoagulant medications)

Oct. 26, 2020, 11:31 p.m. usa

1. treatment with interferons (ifns) immunomodulators and/or immunosuppressive or b-cell depleting medications within 12 months before screening. 2. previous use of interferon lambda. patients who previously participated in a clinical trial of interferon lambda but are confirmed to have received placebo or another non-lambda ifns are allowed. 3. history or evidence of any intolerance or hypersensitivity to ifns. 4. patients with respiratory infection requiring invasive or non-invasive ventilatory support (bipap or intubation and mechanical ventilation). 5. participation in a clinical trial with use of any investigational drug within 30 days before screening. 6. history of any of the following diseases or conditions: - advanced or decompensated liver disease (presence or history of bleeding varices, ascites, encephalopathy or hepato-renal syndrome) - immunologically mediated disease (e.g., rheumatoid arthritis, inflammatory bowel disease, severe psoriasis, systemic lupus erythematosus) that requires more than intermittent nonsteroidal anti-inflammatory medications for management or that requires use of systemic corticosteroids in the 6 months before screening (inhaled asthma medications are allowed). - retinal disorder or clinically relevant ophthalmic disorder. - any malignancy within 5 years before screening. exceptions are superficial dermatologic malignancies (e.g., squamous cell or basal cell skin cancer treated with curative intent). - cardiomyopathy, significant ischemic cardiac or cerebrovascular disease (including history of angina, myocardial infarction, or interventional procedure for coronary artery disease), or cardiac rhythm disorder. - chronic pulmonary disease (e.g., chronic obstructive pulmonary disease) associated with functional impairment. - pancreatitis. - severe or uncontrolled psychiatric disorder, e.g., depression, manic condition, psychosis, acute and/or chronic cognitive dysfunction, suicidal behavior, and relapse of substance abuse. - active seizure disorder defined by either an untreated seizure disorder or continued seizure activity within the preceding year despite treatment with anti-seizure medication. - bone marrow or solid organ transplantation - other significant medical condition that may require intervention during the trial (such as uncontrolled diabetes or thyroid disease) patients with any serious condition that, in the opinion of the investigator, would preclude evaluation of response or make it unlikely that the contemplated course of therapy and follow-up could be completed. patients for whom participation in the trial would increase their risk. - current eating disorder - current alcohol abuse (excessive alcohol intake, defined as follows: >20 g/day for females [1.5 standard alcohol drinks] or >30 g/day for males [2.0 standard alcohol drinks]. a standard drink contains 14 g of alcohol: 360 ml of beer, 150 ml of wine, or 45 ml of spirits - drug abuse within the previous 6 months before screening, with the exception of cannabinoids and their derivatives 7. any of the following abnormal laboratory test in the 12 months prior to enrollment - platelet count <90,000 cells/mm3 - white blood cell (wbc) count <3,000 cells/mm3 - absolute neutrophil count (anc) <1,500 cells/mm3 - hemoglobin <11 g/dl for women and <12 g/dl for men - estimated creatinine clearance (crcl) < 50 ml/min by cockroft-gault formulation - alt and/or alt levels > 10 times the upper limit of normal - bilirubin level ≥ 2.5 mg/dl unless due to gilbert's syndrome - serum albumin level <3.5 g/dl - international normalized ratio (inr) ≥1.5 (except patients maintained on anticoagulant medications)

1. treatment with interferons (ifns) immunomodulators and/or immunosuppressive or b-cell depleting medications within 12 months before screening. 2. previous use of interferon lambda. patients who previously participated in a clinical trial of interferon lambda but are confirmed to have received placebo or another non-lambda ifns are allowed. 3. history or evidence of any intolerance or hypersensitivity to ifns. 4. patients with respiratory infection requiring invasive or non-invasive ventilatory support (bipap or intubation and mechanical ventilation). 5. participation in a clinical trial with use of any investigational drug within 30 days before screening. 6. history of any of the following diseases or conditions: - advanced or decompensated liver disease (presence or history of bleeding varices, ascites, encephalopathy or hepato-renal syndrome) - immunologically mediated disease (e.g., rheumatoid arthritis, inflammatory bowel disease, severe psoriasis, systemic lupus erythematosus) that requires more than intermittent nonsteroidal anti-inflammatory medications for management or that requires use of systemic corticosteroids in the 6 months before screening (inhaled asthma medications are allowed). - retinal disorder or clinically relevant ophthalmic disorder. - any malignancy within 5 years before screening. exceptions are superficial dermatologic malignancies (e.g., squamous cell or basal cell skin cancer treated with curative intent). - cardiomyopathy, significant ischemic cardiac or cerebrovascular disease (including history of angina, myocardial infarction, or interventional procedure for coronary artery disease), or cardiac rhythm disorder. - chronic pulmonary disease (e.g., chronic obstructive pulmonary disease) associated with functional impairment. - pancreatitis. - severe or uncontrolled psychiatric disorder, e.g., depression, manic condition, psychosis, acute and/or chronic cognitive dysfunction, suicidal behavior, and relapse of substance abuse. - active seizure disorder defined by either an untreated seizure disorder or continued seizure activity within the preceding year despite treatment with anti-seizure medication. - bone marrow or solid organ transplantation - other significant medical condition that may require intervention during the trial (such as uncontrolled diabetes or thyroid disease) patients with any serious condition that, in the opinion of the investigator, would preclude evaluation of response or make it unlikely that the contemplated course of therapy and follow-up could be completed. patients for whom participation in the trial would increase their risk. - current eating disorder - current alcohol abuse (excessive alcohol intake, defined as follows: >20 g/day for females [1.5 standard alcohol drinks] or >30 g/day for males [2.0 standard alcohol drinks]. a standard drink contains 14 g of alcohol: 360 ml of beer, 150 ml of wine, or 45 ml of spirits - drug abuse within the previous 6 months before screening, with the exception of cannabinoids and their derivatives 7. any of the following abnormal laboratory test in the 12 months prior to enrollment - platelet count <90,000 cells/mm3 - white blood cell (wbc) count <3,000 cells/mm3 - absolute neutrophil count (anc) <1,500 cells/mm3 - hemoglobin <11 g/dl for women and <12 g/dl for men - estimated creatinine clearance (crcl) < 50 ml/min by cockroft-gault formulation - alt and/or alt levels > 10 times the upper limit of normal - bilirubin level ≥ 2.5 mg/dl unless due to gilbert's syndrome - serum albumin level <3.5 g/dl - international normalized ratio (inr) ≥1.5 (except patients maintained on anticoagulant medications)