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ID

40905

Description

An Efficacy and Safety Study of a 8 or 12-Week Treatment Regimen of Simeprevir in Combination With Sofosbuvir in Treatment-Naive and Experienced Participants With Chronic Genotype 4 Hepatitis C Virus Infection; ODM derived from: https://clinicaltrials.gov/show/NCT02278419

Link

https://clinicaltrials.gov/show/NCT02278419

Keywords

Versions (1)
  1. 6/2/20 6/2/20 -
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See clinicaltrials.gov

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June 2, 2020

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Creative Commons BY 4.0
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    Eligibility Hepatitis C NCT02278419

    English

    Eligibility Hepatitis C NCT02278419

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    participant must have hepatitis c virus (hcv) genotype 4 infection (confirmed at screening)
    Description

    Hepatitis C Genotype

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0019196
    UMLS CUI [1,2]
    C1533728
    participant must have hcv ribonucleic acid (rna) greater than (>) 10,000 international unit per milliliter (iu/ml) at screening
    Description

    Hepatitis C virus RNA assay

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1272251
    in participants with cirrhosis, a documented hepatic imaging procedure (ultrasound, computed tomography [ct] scan, or magnetic resonance imaging [mri]) within 6 months before baseline (day 1) to exclude hepatocellular carcinoma is required
    Description

    Liver Cirrhosis | Requirement Imaging procedure Hepatic | Ultrasonography | Computed Tomography | Magnetic Resonance Imaging | Liver carcinoma Excluded

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0023890
    UMLS CUI [2,1]
    C1514873
    UMLS CUI [2,2]
    C0079595
    UMLS CUI [2,3]
    C0205054
    UMLS CUI [3]
    C0041618
    UMLS CUI [4]
    C0040405
    UMLS CUI [5]
    C0024485
    UMLS CUI [6,1]
    C2239176
    UMLS CUI [6,2]
    C0332196
    a woman of childbearing potential must have a negative serum (beta human chorionic gonadotropin at screening and a negative urine pregnancy test on day 1 before first dose of study drug
    Description

    Childbearing Potential Serum pregnancy test (B-HCG) Negative | Childbearing Potential Urine pregnancy test negative

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C3831118
    UMLS CUI [1,2]
    C0430060
    UMLS CUI [1,3]
    C1513916
    UMLS CUI [2,1]
    C3831118
    UMLS CUI [2,2]
    C0430057
    females of childbearing potential or males with a female partner of childbearing potential must agree to use 2 highly effective contraceptive methods (one of which is a barrier method; eg, condom or diaphragm) from day 1 (baseline) and continue until 30 days after the end of treatment (eot) (or longer if dictated by local regulations), or not be heterosexually active, or be a vasectomized male subject or a female subject with a vasectomized partner, or be a female (subject or partner of male subject) of non-childbearing potential (ie, postmenopausal for at least 2 years or surgically sterile)
    Description

    Childbearing Potential Contraceptive methods Quantity | Gender Partner Childbearing Potential | Contraceptive methods Quantity | Contraception, Barrier | Condom | Vaginal contraceptive diaphragm | Sexually active heterosexual activity Absent | Vasectomy | Gender Partner Vasectomy | Postmenopausal state | Female Sterilization

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C3831118
    UMLS CUI [1,2]
    C0700589
    UMLS CUI [1,3]
    C1265611
    UMLS CUI [2,1]
    C0079399
    UMLS CUI [2,2]
    C0682323
    UMLS CUI [2,3]
    C3831118
    UMLS CUI [3,1]
    C0700589
    UMLS CUI [3,2]
    C1265611
    UMLS CUI [4]
    C0004764
    UMLS CUI [5]
    C0677582
    UMLS CUI [6]
    C0042241
    UMLS CUI [7,1]
    C4272228
    UMLS CUI [7,2]
    C0332197
    UMLS CUI [8]
    C0042387
    UMLS CUI [9,1]
    C0079399
    UMLS CUI [9,2]
    C0682323
    UMLS CUI [9,3]
    C0042387
    UMLS CUI [10]
    C0232970
    UMLS CUI [11]
    C0015787
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    participant has evidence of clinical hepatic decompensation (history or current evidence of ascites, bleeding varices, or hepatic encephalopathy)
    Description

    Hepatic decompensation | Ascites | Bleeding varices | Hepatic Encephalopathy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1394798
    UMLS CUI [2]
    C0003962
    UMLS CUI [3]
    C0333106
    UMLS CUI [4]
    C0019151
    participant has any liver disease of non-hcv etiology. this includes, but is not limited to, acute hepatitis a, drug- or alcohol-related liver disease, autoimmune hepatitis, hemochromatosis, wilson's disease, alpha-1 antitrypsin deficiency, non-alcoholic steatohepatitis, primary biliary cirrhosis, or any other non-hcv liver disease considered clinically significant by the investigator
    Description

    Liver disease Independent of Hepatitis C virus | Hepatitis A | Liver disease Drug-induced | Alcohol-related liver disease | Hepatitis, Autoimmune | Hemochromatosis | Hepatolenticular Degeneration | alpha 1-Antitrypsin Deficiency | Nonalcoholic Steatohepatitis | Primary biliary cirrhosis

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0023895
    UMLS CUI [1,2]
    C0332291
    UMLS CUI [1,3]
    C0220847
    UMLS CUI [2]
    C0019159
    UMLS CUI [3,1]
    C0023895
    UMLS CUI [3,2]
    C0458082
    UMLS CUI [4]
    C0810031
    UMLS CUI [5]
    C0241910
    UMLS CUI [6]
    C0018995
    UMLS CUI [7]
    C0019202
    UMLS CUI [8]
    C0221757
    UMLS CUI [9]
    C3241937
    UMLS CUI [10]
    C0008312
    participant is infected/co-infected with non-genotype 4 hcv
    Description

    Hepatitis C Except Genotype Specified | HCV coinfection Except Genotype Specified

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0019196
    UMLS CUI [1,2]
    C0332300
    UMLS CUI [1,3]
    C1148363
    UMLS CUI [1,4]
    C0205369
    UMLS CUI [2,1]
    C1698259
    UMLS CUI [2,2]
    C0332300
    UMLS CUI [2,3]
    C1148363
    UMLS CUI [2,4]
    C0205369
    participant has any other active clinically significant disease or clinically significant findings during screening of medical history, physical examination, laboratory testing or electrocardiogram (ecg) recordings that, in the investigator's opinion, would compromise the participant's safety or could interfere with the participant participating in and completing the study
    Description

    Disease Clinical Significance At risk Patient safety | Disease Interferes with Study Subject Participation Status | Disease Interferes with Completion of clinical trial | Signs and Symptoms Clinical Significance | Medical History | Physical Examination | Laboratory Procedures | Electrocardiography

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C2826293
    UMLS CUI [1,3]
    C1444641
    UMLS CUI [1,4]
    C1113679
    UMLS CUI [2,1]
    C0012634
    UMLS CUI [2,2]
    C0521102
    UMLS CUI [2,3]
    C2348568
    UMLS CUI [3,1]
    C0012634
    UMLS CUI [3,2]
    C0521102
    UMLS CUI [3,3]
    C2732579
    UMLS CUI [4,1]
    C0037088
    UMLS CUI [4,2]
    C2826293
    UMLS CUI [5]
    C0262926
    UMLS CUI [6]
    C0031809
    UMLS CUI [7]
    C0022885
    UMLS CUI [8]
    C1623258
    participant has history of malignancy within 5 years of the screening visit (exceptions: skin carcinomas, carcinoma in situ of the cervix, or malignancy that in the opinion of the investigator is considered cured with minimal risk of recurrence)
    Description

    Malignant Neoplasms | Exception Skin carcinoma | Exception Carcinoma in situ of uterine cervix | Exception Malignant Neoplasm Cured | Exception Minimal Risk Recurrence

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0006826
    UMLS CUI [2,1]
    C1705847
    UMLS CUI [2,2]
    C0699893
    UMLS CUI [3,1]
    C1705847
    UMLS CUI [3,2]
    C0851140
    UMLS CUI [4,1]
    C1705847
    UMLS CUI [4,2]
    C0006826
    UMLS CUI [4,3]
    C1880198
    UMLS CUI [5,1]
    C1705847
    UMLS CUI [5,2]
    C4528387
    UMLS CUI [5,3]
    C1458156
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    Similar models

    Eligibility Hepatitis C NCT02278419

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Hepatitis C Genotype
    Item
    participant must have hepatitis c virus (hcv) genotype 4 infection (confirmed at screening)
    boolean
    C0019196 (UMLS CUI [1,1])
    C1533728 (UMLS CUI [1,2])
    Hepatitis C virus RNA assay
    Item
    participant must have hcv ribonucleic acid (rna) greater than (>) 10,000 international unit per milliliter (iu/ml) at screening
    boolean
    C1272251 (UMLS CUI [1])
    Liver Cirrhosis | Requirement Imaging procedure Hepatic | Ultrasonography | Computed Tomography | Magnetic Resonance Imaging | Liver carcinoma Excluded
    Item
    in participants with cirrhosis, a documented hepatic imaging procedure (ultrasound, computed tomography [ct] scan, or magnetic resonance imaging [mri]) within 6 months before baseline (day 1) to exclude hepatocellular carcinoma is required
    boolean
    C0023890 (UMLS CUI [1])
    C1514873 (UMLS CUI [2,1])
    C0079595 (UMLS CUI [2,2])
    C0205054 (UMLS CUI [2,3])
    C0041618 (UMLS CUI [3])
    C0040405 (UMLS CUI [4])
    C0024485 (UMLS CUI [5])
    C2239176 (UMLS CUI [6,1])
    C0332196 (UMLS CUI [6,2])
    Childbearing Potential Serum pregnancy test (B-HCG) Negative | Childbearing Potential Urine pregnancy test negative
    Item
    a woman of childbearing potential must have a negative serum (beta human chorionic gonadotropin at screening and a negative urine pregnancy test on day 1 before first dose of study drug
    boolean
    C3831118 (UMLS CUI [1,1])
    C0430060 (UMLS CUI [1,2])
    C1513916 (UMLS CUI [1,3])
    C3831118 (UMLS CUI [2,1])
    C0430057 (UMLS CUI [2,2])
    Childbearing Potential Contraceptive methods Quantity | Gender Partner Childbearing Potential | Contraceptive methods Quantity | Contraception, Barrier | Condom | Vaginal contraceptive diaphragm | Sexually active heterosexual activity Absent | Vasectomy | Gender Partner Vasectomy | Postmenopausal state | Female Sterilization
    Item
    females of childbearing potential or males with a female partner of childbearing potential must agree to use 2 highly effective contraceptive methods (one of which is a barrier method; eg, condom or diaphragm) from day 1 (baseline) and continue until 30 days after the end of treatment (eot) (or longer if dictated by local regulations), or not be heterosexually active, or be a vasectomized male subject or a female subject with a vasectomized partner, or be a female (subject or partner of male subject) of non-childbearing potential (ie, postmenopausal for at least 2 years or surgically sterile)
    boolean
    C3831118 (UMLS CUI [1,1])
    C0700589 (UMLS CUI [1,2])
    C1265611 (UMLS CUI [1,3])
    C0079399 (UMLS CUI [2,1])
    C0682323 (UMLS CUI [2,2])
    C3831118 (UMLS CUI [2,3])
    C0700589 (UMLS CUI [3,1])
    C1265611 (UMLS CUI [3,2])
    C0004764 (UMLS CUI [4])
    C0677582 (UMLS CUI [5])
    C0042241 (UMLS CUI [6])
    C4272228 (UMLS CUI [7,1])
    C0332197 (UMLS CUI [7,2])
    C0042387 (UMLS CUI [8])
    C0079399 (UMLS CUI [9,1])
    C0682323 (UMLS CUI [9,2])
    C0042387 (UMLS CUI [9,3])
    C0232970 (UMLS CUI [10])
    C0015787 (UMLS CUI [11])
    Item Group
    C0680251 (UMLS CUI)
    Hepatic decompensation | Ascites | Bleeding varices | Hepatic Encephalopathy
    Item
    participant has evidence of clinical hepatic decompensation (history or current evidence of ascites, bleeding varices, or hepatic encephalopathy)
    boolean
    C1394798 (UMLS CUI [1])
    C0003962 (UMLS CUI [2])
    C0333106 (UMLS CUI [3])
    C0019151 (UMLS CUI [4])
    Liver disease Independent of Hepatitis C virus | Hepatitis A | Liver disease Drug-induced | Alcohol-related liver disease | Hepatitis, Autoimmune | Hemochromatosis | Hepatolenticular Degeneration | alpha 1-Antitrypsin Deficiency | Nonalcoholic Steatohepatitis | Primary biliary cirrhosis
    Item
    participant has any liver disease of non-hcv etiology. this includes, but is not limited to, acute hepatitis a, drug- or alcohol-related liver disease, autoimmune hepatitis, hemochromatosis, wilson's disease, alpha-1 antitrypsin deficiency, non-alcoholic steatohepatitis, primary biliary cirrhosis, or any other non-hcv liver disease considered clinically significant by the investigator
    boolean
    C0023895 (UMLS CUI [1,1])
    C0332291 (UMLS CUI [1,2])
    C0220847 (UMLS CUI [1,3])
    C0019159 (UMLS CUI [2])
    C0023895 (UMLS CUI [3,1])
    C0458082 (UMLS CUI [3,2])
    C0810031 (UMLS CUI [4])
    C0241910 (UMLS CUI [5])
    C0018995 (UMLS CUI [6])
    C0019202 (UMLS CUI [7])
    C0221757 (UMLS CUI [8])
    C3241937 (UMLS CUI [9])
    C0008312 (UMLS CUI [10])
    Hepatitis C Except Genotype Specified | HCV coinfection Except Genotype Specified
    Item
    participant is infected/co-infected with non-genotype 4 hcv
    boolean
    C0019196 (UMLS CUI [1,1])
    C0332300 (UMLS CUI [1,2])
    C1148363 (UMLS CUI [1,3])
    C0205369 (UMLS CUI [1,4])
    C1698259 (UMLS CUI [2,1])
    C0332300 (UMLS CUI [2,2])
    C1148363 (UMLS CUI [2,3])
    C0205369 (UMLS CUI [2,4])
    Disease Clinical Significance At risk Patient safety | Disease Interferes with Study Subject Participation Status | Disease Interferes with Completion of clinical trial | Signs and Symptoms Clinical Significance | Medical History | Physical Examination | Laboratory Procedures | Electrocardiography
    Item
    participant has any other active clinically significant disease or clinically significant findings during screening of medical history, physical examination, laboratory testing or electrocardiogram (ecg) recordings that, in the investigator's opinion, would compromise the participant's safety or could interfere with the participant participating in and completing the study
    boolean
    C0012634 (UMLS CUI [1,1])
    C2826293 (UMLS CUI [1,2])
    C1444641 (UMLS CUI [1,3])
    C1113679 (UMLS CUI [1,4])
    C0012634 (UMLS CUI [2,1])
    C0521102 (UMLS CUI [2,2])
    C2348568 (UMLS CUI [2,3])
    C0012634 (UMLS CUI [3,1])
    C0521102 (UMLS CUI [3,2])
    C2732579 (UMLS CUI [3,3])
    C0037088 (UMLS CUI [4,1])
    C2826293 (UMLS CUI [4,2])
    C0262926 (UMLS CUI [5])
    C0031809 (UMLS CUI [6])
    C0022885 (UMLS CUI [7])
    C1623258 (UMLS CUI [8])
    Malignant Neoplasms | Exception Skin carcinoma | Exception Carcinoma in situ of uterine cervix | Exception Malignant Neoplasm Cured | Exception Minimal Risk Recurrence
    Item
    participant has history of malignancy within 5 years of the screening visit (exceptions: skin carcinomas, carcinoma in situ of the cervix, or malignancy that in the opinion of the investigator is considered cured with minimal risk of recurrence)
    boolean
    C0006826 (UMLS CUI [1])
    C1705847 (UMLS CUI [2,1])
    C0699893 (UMLS CUI [2,2])
    C1705847 (UMLS CUI [3,1])
    C0851140 (UMLS CUI [3,2])
    C1705847 (UMLS CUI [4,1])
    C0006826 (UMLS CUI [4,2])
    C1880198 (UMLS CUI [4,3])
    C1705847 (UMLS CUI [5,1])
    C4528387 (UMLS CUI [5,2])
    C1458156 (UMLS CUI [5,3])
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