ID

44435

Description

A Study of Sustained Virological Response in Relation to IL28-b Expression in Treatment-Naïve Patients With Chronic Hepatitis C Genotype 1 on Combination Treatment With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin); ODM derived from: https://clinicaltrials.gov/show/NCT01447420

Link

https://clinicaltrials.gov/show/NCT01447420

Keywords

Versions (2)
  1. 2/12/20 2/12/20 -
  2. 9/20/21 9/20/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatitis C, Chronic NCT01447420

English

Eligibility Hepatitis C, Chronic NCT01447420

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult patients, >/=18 and <70 years of age at initiation of treatment
Description

Adult | Age

Data type

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
body weight between 50 kg and 125 kg at baseline
Description

Body Weight

Data type

boolean

Alias
UMLS CUI [1]
C0005910
chronic hepatitis c, genotype 1
Description

Chronic Hepatitis C Genotype

Data type

boolean

Alias
UMLS CUI [1,1]
C0524910
UMLS CUI [1,2]
C1533728
chronic liver disease consistent with hcv infection
Description

Chronic liver disease Consistent with Hepatitis C

Data type

boolean

Alias
UMLS CUI [1,1]
C0341439
UMLS CUI [1,2]
C0332290
UMLS CUI [1,3]
C0019196
compensated liver disease (child-pugh grade a)
Description

Compensated liver disease Child-Pugh Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C3839044
UMLS CUI [1,2]
C4050412
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant or lactating women, and male partners of pregnant women
Description

Pregnancy | Breast Feeding | Gender Partner Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0682323
UMLS CUI [3,3]
C0032961
chronic hepatitis c, genotype 2, 3, 4, 5 or 6
Description

Chronic Hepatitis C Genotype

Data type

boolean

Alias
UMLS CUI [1,1]
C0524910
UMLS CUI [1,2]
C1533728
previous treatment with interferon or ribavirin
Description

Prior Therapy | Interferon | Ribavirin

Data type

boolean

Alias
UMLS CUI [1]
C1514463
UMLS CUI [2]
C3652465
UMLS CUI [3]
C0035525
positive for hepatitis a, hepatitis b or hiv infection
Description

Hepatitis A positive | Hepatitis B positive | HIV Seropositivity

Data type

boolean

Alias
UMLS CUI [1]
C1112370
UMLS CUI [2]
C0856706
UMLS CUI [3]
C0019699
history or evidence of a medical condition associated with liver disease other than chronic hepatitis c
Description

Medical condition Associated with Liver disease | Exception Chronic Hepatitis C

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C0023895
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0524910
decompensated liver disease and/or liver disease child-pugh classification >6
Description

Decompensated liver disease | Liver disease Child-Pugh Classification

Data type

boolean

Alias
UMLS CUI [1]
C4075847
UMLS CUI [2,1]
C0023895
UMLS CUI [2,2]
C4050412
hepatocellular carcinoma
Description

Liver carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C2239176
history or evidence of esophageal bleeding
Description

Esophageal bleeding

Data type

boolean

Alias
UMLS CUI [1]
C0239293
hemoglobinopathy, or any other cause for possible hemolysis
Description

Hemoglobinopathy | Cause Hemolysis Possible

Data type

boolean

Alias
UMLS CUI [1]
C0019045
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0019054
UMLS CUI [2,3]
C0332149
hb <11 g/dl in women, <12 g/l in males
Description

Hemoglobin measurement | Gender

Data type

boolean

Alias
UMLS CUI [1]
C0518015
UMLS CUI [2]
C0079399
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Similar models

Eligibility Hepatitis C, Chronic NCT01447420

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Age
Item
adult patients, >/=18 and <70 years of age at initiation of treatment
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Body Weight
Item
body weight between 50 kg and 125 kg at baseline
boolean
C0005910 (UMLS CUI [1])
Chronic Hepatitis C Genotype
Item
chronic hepatitis c, genotype 1
boolean
C0524910 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
Chronic liver disease Consistent with Hepatitis C
Item
chronic liver disease consistent with hcv infection
boolean
C0341439 (UMLS CUI [1,1])
C0332290 (UMLS CUI [1,2])
C0019196 (UMLS CUI [1,3])
Compensated liver disease Child-Pugh Classification
Item
compensated liver disease (child-pugh grade a)
boolean
C3839044 (UMLS CUI [1,1])
C4050412 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding | Gender Partner Pregnancy
Item
pregnant or lactating women, and male partners of pregnant women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0079399 (UMLS CUI [3,1])
C0682323 (UMLS CUI [3,2])
C0032961 (UMLS CUI [3,3])
Chronic Hepatitis C Genotype
Item
chronic hepatitis c, genotype 2, 3, 4, 5 or 6
boolean
C0524910 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
Prior Therapy | Interferon | Ribavirin
Item
previous treatment with interferon or ribavirin
boolean
C1514463 (UMLS CUI [1])
C3652465 (UMLS CUI [2])
C0035525 (UMLS CUI [3])
Hepatitis A positive | Hepatitis B positive | HIV Seropositivity
Item
positive for hepatitis a, hepatitis b or hiv infection
boolean
C1112370 (UMLS CUI [1])
C0856706 (UMLS CUI [2])
C0019699 (UMLS CUI [3])
Medical condition Associated with Liver disease | Exception Chronic Hepatitis C
Item
history or evidence of a medical condition associated with liver disease other than chronic hepatitis c
boolean
C3843040 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0023895 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0524910 (UMLS CUI [2,2])
Decompensated liver disease | Liver disease Child-Pugh Classification
Item
decompensated liver disease and/or liver disease child-pugh classification >6
boolean
C4075847 (UMLS CUI [1])
C0023895 (UMLS CUI [2,1])
C4050412 (UMLS CUI [2,2])
Liver carcinoma
Item
hepatocellular carcinoma
boolean
C2239176 (UMLS CUI [1])
Esophageal bleeding
Item
history or evidence of esophageal bleeding
boolean
C0239293 (UMLS CUI [1])
Hemoglobinopathy | Cause Hemolysis Possible
Item
hemoglobinopathy, or any other cause for possible hemolysis
boolean
C0019045 (UMLS CUI [1])
C0015127 (UMLS CUI [2,1])
C0019054 (UMLS CUI [2,2])
C0332149 (UMLS CUI [2,3])
Hemoglobin measurement | Gender
Item
hb <11 g/dl in women, <12 g/l in males
boolean
C0518015 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
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