ID

33818

Description

Safety Study of Pegylated Interferon Lambda Plus Single or 2 Direct Antiviral Agents With Ribavirin; ODM derived from: https://clinicaltrials.gov/show/NCT01795911

Link

https://clinicaltrials.gov/show/NCT01795911

Keywords

  1. 12/28/18 12/28/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

December 28, 2018

DOI

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License

Creative Commons BY 4.0

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Eligibility Hepatitis C NCT01795911

Eligibility Hepatitis C NCT01795911

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
chronic hepatitis c, genotype 1
Description

Chronic Hepatitis C Genotype

Data type

boolean

Alias
UMLS CUI [1,1]
C0524910
UMLS CUI [1,2]
C0017431
hcv rna >100,000 iu/ml at screening;
Description

Hepatitis C virus RNA Viral load measurement

Data type

boolean

Alias
UMLS CUI [1,1]
C0369335
UMLS CUI [1,2]
C1261478
seronegative for human immunodeficiency virus (hiv) and hepatitis b surface antigen (hbsag);
Description

HIV Seronegative | Hepatitis B Surface Antigens Seronegative

Data type

boolean

Alias
UMLS CUI [1,1]
C0019682
UMLS CUI [1,2]
C0521144
UMLS CUI [2,1]
C0019168
UMLS CUI [2,2]
C0521144
liver biopsy within prior 2 years; subjects with compensated cirrhosis can enroll and will be capped at approximately 10%
Description

Biopsy of liver | Compensated cirrhosis

Data type

boolean

Alias
UMLS CUI [1]
C0193388
UMLS CUI [2]
C1608426
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
any evidence of liver disease other than hcv;
Description

Liver disease | Exception HCV

Data type

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0220847
co-infection with hiv;
Description

HIV coinfection

Data type

boolean

Alias
UMLS CUI [1]
C4062778
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
medical history or laboratory value abnormalities that would prohibit the use of pegylated interferon alpha-2a or ribavirin
Description

Medical History Preventing Peginterferon alfa-2a | Medical History Preventing Ribavirin | Laboratory test result abnormal Preventing Peginterferon alfa-2a | Laboratory test result abnormal Preventing Ribavirin

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C0391001
UMLS CUI [2,1]
C0262926
UMLS CUI [2,2]
C1292733
UMLS CUI [2,3]
C0035525
UMLS CUI [3,1]
C0438215
UMLS CUI [3,2]
C1292733
UMLS CUI [3,3]
C0391001
UMLS CUI [4,1]
C0438215
UMLS CUI [4,2]
C1292733
UMLS CUI [4,3]
C0035525

Similar models

Eligibility Hepatitis C NCT01795911

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Chronic Hepatitis C Genotype
Item
chronic hepatitis c, genotype 1
boolean
C0524910 (UMLS CUI [1,1])
C0017431 (UMLS CUI [1,2])
Hepatitis C virus RNA Viral load measurement
Item
hcv rna >100,000 iu/ml at screening;
boolean
C0369335 (UMLS CUI [1,1])
C1261478 (UMLS CUI [1,2])
HIV Seronegative | Hepatitis B Surface Antigens Seronegative
Item
seronegative for human immunodeficiency virus (hiv) and hepatitis b surface antigen (hbsag);
boolean
C0019682 (UMLS CUI [1,1])
C0521144 (UMLS CUI [1,2])
C0019168 (UMLS CUI [2,1])
C0521144 (UMLS CUI [2,2])
Biopsy of liver | Compensated cirrhosis
Item
liver biopsy within prior 2 years; subjects with compensated cirrhosis can enroll and will be capped at approximately 10%
boolean
C0193388 (UMLS CUI [1])
C1608426 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Liver disease | Exception HCV
Item
any evidence of liver disease other than hcv;
boolean
C0023895 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0220847 (UMLS CUI [2,2])
HIV coinfection
Item
co-infection with hiv;
boolean
C4062778 (UMLS CUI [1])
Liver carcinoma | Liver carcinoma Suspected
Item
diagnosed or suspected hepatocellular carcinoma;
boolean
C2239176 (UMLS CUI [1])
C2239176 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
Medical History Preventing Peginterferon alfa-2a | Medical History Preventing Ribavirin | Laboratory test result abnormal Preventing Peginterferon alfa-2a | Laboratory test result abnormal Preventing Ribavirin
Item
medical history or laboratory value abnormalities that would prohibit the use of pegylated interferon alpha-2a or ribavirin
boolean
C0262926 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C0391001 (UMLS CUI [1,3])
C0262926 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C0035525 (UMLS CUI [2,3])
C0438215 (UMLS CUI [3,1])
C1292733 (UMLS CUI [3,2])
C0391001 (UMLS CUI [3,3])
C0438215 (UMLS CUI [4,1])
C1292733 (UMLS CUI [4,2])
C0035525 (UMLS CUI [4,3])

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