ID

40906

Description

Ph IIA Study (SOC +/- NS5B); ODM derived from: https://clinicaltrials.gov/show/NCT01193361

Link

https://clinicaltrials.gov/show/NCT01193361

Keywords

Versions (1)
  1. 6/2/20 6/2/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 2, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatitis C Virus NCT01193361

English

Eligibility Hepatitis C Virus NCT01193361

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects chronically infected with hcv genotype 1 as documented by: positive for anti-hcv antibody, hcv rna, or a positive hcv genotype test at least 6 months prior to screening, and positive for hcv rna and anti-hcv antibody at screening
Description

Chronic Hepatitis C Genotype | Hepatitis C antibody positive | Hepatitis C RNA positive | Hepatitis c viral genotype Positive

Data type

boolean

Alias
UMLS CUI [1,1]
C0524910
UMLS CUI [1,2]
C1533728
UMLS CUI [2]
C0281863
UMLS CUI [3]
C0855842
UMLS CUI [4,1]
C4272868
UMLS CUI [4,2]
C1514241
hcv rna ≥ 10*5* iu/ml at screening
Description

Hepatitis C virus RNA assay

Data type

boolean

Alias
UMLS CUI [1]
C1272251
less than 4 weeks total prior therapy with an ifn formulation (ie, ifnα, pegifnα-2a), or rbv and no exposure to ifn or rbv within 24 weeks of randomization
Description

Prior Therapy | Interferon Formulation | Interferon-alpha | peginterferon alfa-2a | Ribavirin

Data type

boolean

Alias
UMLS CUI [1]
C1514463
UMLS CUI [2,1]
C3652465
UMLS CUI [2,2]
C0524527
UMLS CUI [3]
C0002199
UMLS CUI [4]
C0391001
UMLS CUI [5]
C0035525
results of a biopsy obtained ≤ 24 months prior to randomization showing no evidence of cirrhosis
Description

Liver Cirrhosis Absent Biopsy

Data type

boolean

Alias
UMLS CUI [1,1]
C0023890
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0005558
body mass index (bmi) of 18 to 35 kg/m², inclusive. bmi = weight (kg)/ [height (m)]²
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
at screening
Description

ID.6

Data type

boolean

Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
liver transplant recipients
Description

Recipient Liver transplant

Data type

boolean

Alias
UMLS CUI [1,1]
C1709854
UMLS CUI [1,2]
C0023911
documented or suspected hcc by imaging or liver biopsy
Description

Liver carcinoma Imaging | Liver carcinoma Suspected Imaging | Liver carcinoma Biopsy of liver | Liver carcinoma Suspected Biopsy of liver

Data type

boolean

Alias
UMLS CUI [1,1]
C2239176
UMLS CUI [1,2]
C0011923
UMLS CUI [2,1]
C2239176
UMLS CUI [2,2]
C0750491
UMLS CUI [2,3]
C0011923
UMLS CUI [3,1]
C2239176
UMLS CUI [3,2]
C0193388
UMLS CUI [4,1]
C2239176
UMLS CUI [4,2]
C0750491
UMLS CUI [4,3]
C0193388
evidence of a medical condition associated with chronic liver disease other than hcv (such as but not limited to: hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures)
Description

Medical condition Associated with Chronic liver disease | Exception Hepatitis C | Hemochromatosis | Hepatitis, Autoimmune | Liver disease Metabolic | Alcoholic Liver Disease | Exposure to Toxin

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C0341439
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0019196
UMLS CUI [3]
C0018995
UMLS CUI [4]
C0241910
UMLS CUI [5,1]
C0023895
UMLS CUI [5,2]
C0311400
UMLS CUI [6]
C0023896
UMLS CUI [7,1]
C0332157
UMLS CUI [7,2]
C0040549
history of chronic hepatitis b virus (hbv) as documented by hbv serologies (eg. hbsag-seropositive). patients with resolved hbv infection may participate (eg. hbsab-seropositive)
Description

Hepatitis B, Chronic | Hepatitis b serology | Hepatitis B Surface Antigens Seropositive | Hepatitis B resolved | Hepatitis B Virus Surface Antibody Seropositive

Data type

boolean

Alias
UMLS CUI [1]
C0524909
UMLS CUI [2]
C0744837
UMLS CUI [3,1]
C0019168
UMLS CUI [3,2]
C0521143
UMLS CUI [4,1]
C0019163
UMLS CUI [4,2]
C1514893
UMLS CUI [5,1]
C0369334
UMLS CUI [5,2]
C0521143
current or known history of cancer (except in situ carcinoma of the cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to enrollment
Description

Malignant Neoplasms | Exception Carcinoma in situ of uterine cervix | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0851140
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007117
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0553723
UMLS CUI [4,3]
C1522326
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Similar models

Eligibility Hepatitis C Virus NCT01193361

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Chronic Hepatitis C Genotype | Hepatitis C antibody positive | Hepatitis C RNA positive | Hepatitis c viral genotype Positive
Item
subjects chronically infected with hcv genotype 1 as documented by: positive for anti-hcv antibody, hcv rna, or a positive hcv genotype test at least 6 months prior to screening, and positive for hcv rna and anti-hcv antibody at screening
boolean
C0524910 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
C0281863 (UMLS CUI [2])
C0855842 (UMLS CUI [3])
C4272868 (UMLS CUI [4,1])
C1514241 (UMLS CUI [4,2])
Hepatitis C virus RNA assay
Item
hcv rna ≥ 10*5* iu/ml at screening
boolean
C1272251 (UMLS CUI [1])
Prior Therapy | Interferon Formulation | Interferon-alpha | peginterferon alfa-2a | Ribavirin
Item
less than 4 weeks total prior therapy with an ifn formulation (ie, ifnα, pegifnα-2a), or rbv and no exposure to ifn or rbv within 24 weeks of randomization
boolean
C1514463 (UMLS CUI [1])
C3652465 (UMLS CUI [2,1])
C0524527 (UMLS CUI [2,2])
C0002199 (UMLS CUI [3])
C0391001 (UMLS CUI [4])
C0035525 (UMLS CUI [5])
Liver Cirrhosis Absent Biopsy
Item
results of a biopsy obtained ≤ 24 months prior to randomization showing no evidence of cirrhosis
boolean
C0023890 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0005558 (UMLS CUI [1,3])
Body mass index
Item
body mass index (bmi) of 18 to 35 kg/m², inclusive. bmi = weight (kg)/ [height (m)]²
boolean
C1305855 (UMLS CUI [1])
ID.6
Item
at screening
boolean
Item Group
C0680251 (UMLS CUI)
Recipient Liver transplant
Item
liver transplant recipients
boolean
C1709854 (UMLS CUI [1,1])
C0023911 (UMLS CUI [1,2])
Liver carcinoma Imaging | Liver carcinoma Suspected Imaging | Liver carcinoma Biopsy of liver | Liver carcinoma Suspected Biopsy of liver
Item
documented or suspected hcc by imaging or liver biopsy
boolean
C2239176 (UMLS CUI [1,1])
C0011923 (UMLS CUI [1,2])
C2239176 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0011923 (UMLS CUI [2,3])
C2239176 (UMLS CUI [3,1])
C0193388 (UMLS CUI [3,2])
C2239176 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
C0193388 (UMLS CUI [4,3])
Medical condition Associated with Chronic liver disease | Exception Hepatitis C | Hemochromatosis | Hepatitis, Autoimmune | Liver disease Metabolic | Alcoholic Liver Disease | Exposure to Toxin
Item
evidence of a medical condition associated with chronic liver disease other than hcv (such as but not limited to: hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures)
boolean
C3843040 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0341439 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0019196 (UMLS CUI [2,2])
C0018995 (UMLS CUI [3])
C0241910 (UMLS CUI [4])
C0023895 (UMLS CUI [5,1])
C0311400 (UMLS CUI [5,2])
C0023896 (UMLS CUI [6])
C0332157 (UMLS CUI [7,1])
C0040549 (UMLS CUI [7,2])
Hepatitis B, Chronic | Hepatitis b serology | Hepatitis B Surface Antigens Seropositive | Hepatitis B resolved | Hepatitis B Virus Surface Antibody Seropositive
Item
history of chronic hepatitis b virus (hbv) as documented by hbv serologies (eg. hbsag-seropositive). patients with resolved hbv infection may participate (eg. hbsab-seropositive)
boolean
C0524909 (UMLS CUI [1])
C0744837 (UMLS CUI [2])
C0019168 (UMLS CUI [3,1])
C0521143 (UMLS CUI [3,2])
C0019163 (UMLS CUI [4,1])
C1514893 (UMLS CUI [4,2])
C0369334 (UMLS CUI [5,1])
C0521143 (UMLS CUI [5,2])
Malignant Neoplasms | Exception Carcinoma in situ of uterine cervix | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated
Item
current or known history of cancer (except in situ carcinoma of the cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to enrollment
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0851140 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0553723 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
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