ID

40916

Description

Efficacy of a 12-Week Regimen of Telaprevir, Pegylated Interferon, and Ribavirin in Treatment-Naive and Prior Relapser Subjects With Interleukin28B (IL28B) CC Genotype; ODM derived from: https://clinicaltrials.gov/show/NCT01459913

Link

https://clinicaltrials.gov/show/NCT01459913

Keywords

Versions (1)
  1. 6/4/20 6/4/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 4, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatitis C, Chronic NCT01459913

English

Eligibility Hepatitis C, Chronic NCT01459913

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
male and female subjects, 18 to 70 years of age, inclusive
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
treatment-naive or subjects (prior relapsers) may be included who did not achieve sustained viral response 24 weeks after last planned dose of study drug (svr24) after at least 1 prior course of peg-ifn/rbv therapy of standard duration and had a documented undetectable hcv rna level at the planned end of treatment of at least 42-week duration
Description

Therapy naive | Sustained Virologic Response failed | Status post PEGINTERFERON/RIBAVIRIN | Hepatitis C RNA Undetectable | Status post Treatment completed

Data type

boolean

Alias
UMLS CUI [1]
C0919936
UMLS CUI [2,1]
C4050171
UMLS CUI [2,2]
C0231175
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C1875630
UMLS CUI [4,1]
C0855840
UMLS CUI [4,2]
C3827727
UMLS CUI [5,1]
C0231290
UMLS CUI [5,2]
C0580352
subjects have il28b cc genotype determined during screening
Description

IL28B Genotype determination

Data type

boolean

Alias
UMLS CUI [1,1]
C1425475
UMLS CUI [1,2]
C1285573
subjects have genotype 1 chronic hepatitis c and laboratory evidence of hcv infection for at least 6 months, defined by (1) documented hcv serology test at least 6 months before the first screening visit demonstrating the presence of anti-hcv antibody, or (2) documented presence of hcv rna by a sensitive and specific assay at least 6 months before the first screening visit, or (3) documented histologic evidence of chronic hepatitis c demonstrated by fibrosis on a standardized histologic grading system at least 6 months before the first screening visit. if only inflammation is present in the liver histologic report, then 6 months of laboratory evidence is required
Description

Chronic Hepatitis C Genotype | Hepatitis C Disease length | Hepatitis C virus Serologic test | Hepatitis C Antibodies Present | Hepatitis C virus RNA assay | Hepatitis C, Chronic | Fibrosis

Data type

boolean

Alias
UMLS CUI [1,1]
C0524910
UMLS CUI [1,2]
C1533728
UMLS CUI [2,1]
C0019196
UMLS CUI [2,2]
C0872146
UMLS CUI [3,1]
C0220847
UMLS CUI [3,2]
C0036743
UMLS CUI [4,1]
C0166049
UMLS CUI [4,2]
C0150312
UMLS CUI [5]
C1272251
UMLS CUI [6]
C0524910
UMLS CUI [7]
C0016059
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects have received previous treatment with telaprevir or any other protease inhibitor(s) for chronic hepatitis c
Description

Telaprevir Chronic Hepatitis C | Protease Inhibitors Chronic Hepatitis C

Data type

boolean

Alias
UMLS CUI [1,1]
C1876229
UMLS CUI [1,2]
C0524910
UMLS CUI [2,1]
C0033607
UMLS CUI [2,2]
C0524910
subjects who did not achieve svr24 after at least 1 prior course of peg-ifn/rbv therapy of standard duration and never achieved undetectable hcv rna while on treatment
Description

Sustained Virologic Response failed | Status post PEGINTERFERON/RIBAVIRIN | Hepatitis C RNA Undetectable failed

Data type

boolean

Alias
UMLS CUI [1,1]
C4050171
UMLS CUI [1,2]
C0231175
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C1875630
UMLS CUI [3,1]
C0855840
UMLS CUI [3,2]
C3827727
UMLS CUI [3,3]
C0231175
subjects have evidence of hepatic decompensation
Description

Hepatic decompensation

Data type

boolean

Alias
UMLS CUI [1]
C1394798
subjects have evidence of cirrhosis
Description

Liver Cirrhosis

Data type

boolean

Alias
UMLS CUI [1]
C0023890
subjects have diagnosed or suspected hepatocellular carcinoma
Description

Liver carcinoma | Liver carcinoma Suspected

Data type

boolean

Alias
UMLS CUI [1]
C2239176
UMLS CUI [2,1]
C2239176
UMLS CUI [2,2]
C0750491
subjects have any other cause of significant liver disease in addition to hepatitis c, which may include but is not limited to malignancy with hepatic involvement, hepatitis b, drug or alcohol-related cirrhosis, autoimmune hepatitis, hemochromatosis, wilson's disease, nonalcoholic steatohepatitis, or primary biliary cirrhosis. steatosis is allowed if clinically asymptomatic
Description

Cause Liver disease | In addition to Hepatitis C | Malignant Neoplasm Hepatic Involvement | Hepatitis B | Drug-induced cirrhosis of liver | Liver Cirrhosis, Alcoholic | Hepatitis, Autoimmune | Hemochromatosis | Hepatolenticular Degeneration | Nonalcoholic Steatohepatitis | Primary biliary cirrhosis | Steatosis Asymptomatic allowed

Data type

boolean

Alias
UMLS CUI [1,1]
C0015127
UMLS CUI [1,2]
C0023895
UMLS CUI [2,1]
C0332287
UMLS CUI [2,2]
C0019196
UMLS CUI [3,1]
C0006826
UMLS CUI [3,2]
C0441932
UMLS CUI [4]
C0019163
UMLS CUI [5]
C1960179
UMLS CUI [6]
C0023891
UMLS CUI [7]
C0241910
UMLS CUI [8]
C0018995
UMLS CUI [9]
C0019202
UMLS CUI [10]
C3241937
UMLS CUI [11]
C0008312
UMLS CUI [12,1]
C0152254
UMLS CUI [12,2]
C0231221
UMLS CUI [12,3]
C0683607
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Similar models

Eligibility Hepatitis C, Chronic NCT01459913

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
male and female subjects, 18 to 70 years of age, inclusive
boolean
C0001779 (UMLS CUI [1])
Therapy naive | Sustained Virologic Response failed | Status post PEGINTERFERON/RIBAVIRIN | Hepatitis C RNA Undetectable | Status post Treatment completed
Item
treatment-naive or subjects (prior relapsers) may be included who did not achieve sustained viral response 24 weeks after last planned dose of study drug (svr24) after at least 1 prior course of peg-ifn/rbv therapy of standard duration and had a documented undetectable hcv rna level at the planned end of treatment of at least 42-week duration
boolean
C0919936 (UMLS CUI [1])
C4050171 (UMLS CUI [2,1])
C0231175 (UMLS CUI [2,2])
C0231290 (UMLS CUI [3,1])
C1875630 (UMLS CUI [3,2])
C0855840 (UMLS CUI [4,1])
C3827727 (UMLS CUI [4,2])
C0231290 (UMLS CUI [5,1])
C0580352 (UMLS CUI [5,2])
IL28B Genotype determination
Item
subjects have il28b cc genotype determined during screening
boolean
C1425475 (UMLS CUI [1,1])
C1285573 (UMLS CUI [1,2])
Chronic Hepatitis C Genotype | Hepatitis C Disease length | Hepatitis C virus Serologic test | Hepatitis C Antibodies Present | Hepatitis C virus RNA assay | Hepatitis C, Chronic | Fibrosis
Item
subjects have genotype 1 chronic hepatitis c and laboratory evidence of hcv infection for at least 6 months, defined by (1) documented hcv serology test at least 6 months before the first screening visit demonstrating the presence of anti-hcv antibody, or (2) documented presence of hcv rna by a sensitive and specific assay at least 6 months before the first screening visit, or (3) documented histologic evidence of chronic hepatitis c demonstrated by fibrosis on a standardized histologic grading system at least 6 months before the first screening visit. if only inflammation is present in the liver histologic report, then 6 months of laboratory evidence is required
boolean
C0524910 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
C0019196 (UMLS CUI [2,1])
C0872146 (UMLS CUI [2,2])
C0220847 (UMLS CUI [3,1])
C0036743 (UMLS CUI [3,2])
C0166049 (UMLS CUI [4,1])
C0150312 (UMLS CUI [4,2])
C1272251 (UMLS CUI [5])
C0524910 (UMLS CUI [6])
C0016059 (UMLS CUI [7])
Item Group
C0680251 (UMLS CUI)
Telaprevir Chronic Hepatitis C | Protease Inhibitors Chronic Hepatitis C
Item
subjects have received previous treatment with telaprevir or any other protease inhibitor(s) for chronic hepatitis c
boolean
C1876229 (UMLS CUI [1,1])
C0524910 (UMLS CUI [1,2])
C0033607 (UMLS CUI [2,1])
C0524910 (UMLS CUI [2,2])
Sustained Virologic Response failed | Status post PEGINTERFERON/RIBAVIRIN | Hepatitis C RNA Undetectable failed
Item
subjects who did not achieve svr24 after at least 1 prior course of peg-ifn/rbv therapy of standard duration and never achieved undetectable hcv rna while on treatment
boolean
C4050171 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
C0231290 (UMLS CUI [2,1])
C1875630 (UMLS CUI [2,2])
C0855840 (UMLS CUI [3,1])
C3827727 (UMLS CUI [3,2])
C0231175 (UMLS CUI [3,3])
Hepatic decompensation
Item
subjects have evidence of hepatic decompensation
boolean
C1394798 (UMLS CUI [1])
Liver Cirrhosis
Item
subjects have evidence of cirrhosis
boolean
C0023890 (UMLS CUI [1])
Liver carcinoma | Liver carcinoma Suspected
Item
subjects have diagnosed or suspected hepatocellular carcinoma
boolean
C2239176 (UMLS CUI [1])
C2239176 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
Cause Liver disease | In addition to Hepatitis C | Malignant Neoplasm Hepatic Involvement | Hepatitis B | Drug-induced cirrhosis of liver | Liver Cirrhosis, Alcoholic | Hepatitis, Autoimmune | Hemochromatosis | Hepatolenticular Degeneration | Nonalcoholic Steatohepatitis | Primary biliary cirrhosis | Steatosis Asymptomatic allowed
Item
subjects have any other cause of significant liver disease in addition to hepatitis c, which may include but is not limited to malignancy with hepatic involvement, hepatitis b, drug or alcohol-related cirrhosis, autoimmune hepatitis, hemochromatosis, wilson's disease, nonalcoholic steatohepatitis, or primary biliary cirrhosis. steatosis is allowed if clinically asymptomatic
boolean
C0015127 (UMLS CUI [1,1])
C0023895 (UMLS CUI [1,2])
C0332287 (UMLS CUI [2,1])
C0019196 (UMLS CUI [2,2])
C0006826 (UMLS CUI [3,1])
C0441932 (UMLS CUI [3,2])
C0019163 (UMLS CUI [4])
C1960179 (UMLS CUI [5])
C0023891 (UMLS CUI [6])
C0241910 (UMLS CUI [7])
C0018995 (UMLS CUI [8])
C0019202 (UMLS CUI [9])
C3241937 (UMLS CUI [10])
C0008312 (UMLS CUI [11])
C0152254 (UMLS CUI [12,1])
C0231221 (UMLS CUI [12,2])
C0683607 (UMLS CUI [12,3])
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