ID

44439

Description

A Study of Ritonavir-Boosted Danoprevir and RO5024048 in Different Combinations in Null Responder or Treatment-Naïve Patients With Chronic Hepatitis C and Compensated Cirrhosis; ODM derived from: https://clinicaltrials.gov/show/NCT01483742

Link

https://clinicaltrials.gov/show/NCT01483742

Keywords

  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

To request one please log in.

License

Creative Commons BY 4.0

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Hepatitis C, Chronic NCT01483742

Eligibility Hepatitis C, Chronic NCT01483742

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult patients, 18 to 65 years of age inclusive
Description

Adult | Age

Data type

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
chronic hepatitis c, genotype 1 or 4
Description

Hepatitis C Genotype

Data type

boolean

Alias
UMLS CUI [1,1]
C0019196
UMLS CUI [1,2]
C1533728
cohort 1: treatment-naïve for hepatitis c
Description

Therapy naive Hepatitis C

Data type

boolean

Alias
UMLS CUI [1,1]
C0919936
UMLS CUI [1,2]
C0019196
cohort 2: prior null responder to treatment with approved doses of pegylated interferon plus ribavirin
Description

Therapy non-responder | PEGINTERFERON/RIBAVIRIN Dose Approved

Data type

boolean

Alias
UMLS CUI [1]
C0919875
UMLS CUI [2,1]
C1875630
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205540
liver biopsy confirming cirrhosis
Description

Liver Cirrhosis Confirmed by Biopsy of liver

Data type

boolean

Alias
UMLS CUI [1,1]
C0023890
UMLS CUI [1,2]
C0521093
UMLS CUI [1,3]
C0193388
compensated cirrhosis (child-pugh a)
Description

Compensated cirrhosis Child-Pugh Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C1608426
UMLS CUI [1,2]
C4050412
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant or lactating women or male partners of women who are pregnant
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
history or presence of decompensated liver disease (ascites, hepatic encephalopathy, hepatocellular carcinoma, or bleeding esophageal varices)
Description

Decompensated liver disease | Ascites | Hepatic Encephalopathy | Liver carcinoma | Bleeding esophageal varices

Data type

boolean

Alias
UMLS CUI [1]
C4075847
UMLS CUI [2]
C0003962
UMLS CUI [3]
C0019151
UMLS CUI [4]
C2239176
UMLS CUI [5]
C0155789
cohort 2: patients who discontinued previous pegylated interferon plus ribavirin treatment due to reasons other than null response
Description

PEGINTERFERON/RIBAVIRIN Discontinued | Etiology Except Therapy non-responder

Data type

boolean

Alias
UMLS CUI [1,1]
C1875630
UMLS CUI [1,2]
C1444662
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0332300
UMLS CUI [2,3]
C0919875
history of clinically significant cardiovascular or cerebrovascular disease
Description

Cardiovascular Disease | Cerebrovascular Disorder

Data type

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0007820

Similar models

Eligibility Hepatitis C, Chronic NCT01483742

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Age
Item
adult patients, 18 to 65 years of age inclusive
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Hepatitis C Genotype
Item
chronic hepatitis c, genotype 1 or 4
boolean
C0019196 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
Therapy naive Hepatitis C
Item
cohort 1: treatment-naïve for hepatitis c
boolean
C0919936 (UMLS CUI [1,1])
C0019196 (UMLS CUI [1,2])
Therapy non-responder | PEGINTERFERON/RIBAVIRIN Dose Approved
Item
cohort 2: prior null responder to treatment with approved doses of pegylated interferon plus ribavirin
boolean
C0919875 (UMLS CUI [1])
C1875630 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205540 (UMLS CUI [2,3])
Liver Cirrhosis Confirmed by Biopsy of liver
Item
liver biopsy confirming cirrhosis
boolean
C0023890 (UMLS CUI [1,1])
C0521093 (UMLS CUI [1,2])
C0193388 (UMLS CUI [1,3])
Compensated cirrhosis Child-Pugh Classification
Item
compensated cirrhosis (child-pugh a)
boolean
C1608426 (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 or male partners of women who are pregnant
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0079399 (UMLS CUI [3,1])
C0682323 (UMLS CUI [3,2])
C0032961 (UMLS CUI [3,3])
Decompensated liver disease | Ascites | Hepatic Encephalopathy | Liver carcinoma | Bleeding esophageal varices
Item
history or presence of decompensated liver disease (ascites, hepatic encephalopathy, hepatocellular carcinoma, or bleeding esophageal varices)
boolean
C4075847 (UMLS CUI [1])
C0003962 (UMLS CUI [2])
C0019151 (UMLS CUI [3])
C2239176 (UMLS CUI [4])
C0155789 (UMLS CUI [5])
PEGINTERFERON/RIBAVIRIN Discontinued | Etiology Except Therapy non-responder
Item
cohort 2: patients who discontinued previous pegylated interferon plus ribavirin treatment due to reasons other than null response
boolean
C1875630 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C0015127 (UMLS CUI [2,1])
C0332300 (UMLS CUI [2,2])
C0919875 (UMLS CUI [2,3])
Cardiovascular Disease | Cerebrovascular Disorder
Item
history of clinically significant cardiovascular or cerebrovascular disease
boolean
C0007222 (UMLS CUI [1])
C0007820 (UMLS CUI [2])

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial