ID

39651

Description

Miravirsen Study in Null Responder to Pegylated Interferon Alpha Plus Ribavirin Subjects With Chronic Hepatitis C; ODM derived from: https://clinicaltrials.gov/show/NCT01727934

Link

https://clinicaltrials.gov/show/NCT01727934

Keywords

  1. 2/8/20 2/8/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 8, 2020

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 NCT01727934

Eligibility Hepatitis C NCT01727934

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of chronic hepatitis c
Description

Hepatitis C, Chronic

Data type

boolean

Alias
UMLS CUI [1]
C0524910
hcv genotype 1
Description

Hepatitis C virus genotype

Data type

boolean

Alias
UMLS CUI [1]
C1533728
bmi 18-38 kg/m2
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
null responder to pegylated interferon alpha and ribavirin
Description

Therapy non-responder Pegylated interferon alfa | Therapy non-responder Ribavirin

Data type

boolean

Alias
UMLS CUI [1,1]
C0919875
UMLS CUI [1,2]
C0907160
UMLS CUI [2,1]
C0919875
UMLS CUI [2,2]
C0035525
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
co-infection with hepatitis b virus (hbv) or human immunodeficiency virus (hiv)
Description

HBV coinfection | HIV coinfection

Data type

boolean

Alias
UMLS CUI [1]
C2242656
UMLS CUI [2]
C4062778
significant liver disease in addition to hepatitis c
Description

Liver disease In addition to Hepatitis C

Data type

boolean

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0332287
UMLS CUI [1,3]
C0019196
decompensated liver disease medical history or current clinical features
Description

Decompensated liver disease Medical History | Decompensated liver disease Features Clinical

Data type

boolean

Alias
UMLS CUI [1,1]
C4075847
UMLS CUI [1,2]
C0262926
UMLS CUI [2,1]
C4075847
UMLS CUI [2,2]
C1521970
UMLS CUI [2,3]
C0205210
histologic evidence of hepatic cirrhosis
Description

Liver Cirrhosis

Data type

boolean

Alias
UMLS CUI [1]
C0023890
concurrent clinically significant medical diagnosis (other than chc)
Description

Comorbidity Clinical Significance | Exception Chronic Hepatitis C

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C2826293
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0524910
concurrent social conditions (e.g. drugs of abuse, alcohol excess, poor living accommodation)
Description

Social Conditions Concurrent | Drug abuse | Alcohol intake above recommended sensible limits | Living conditions unsatisfactory

Data type

boolean

Alias
UMLS CUI [1,1]
C0037403
UMLS CUI [1,2]
C0205420
UMLS CUI [2]
C0013146
UMLS CUI [3]
C0560219
UMLS CUI [4]
C0337630
clinically significant illness within 30 days preceding entry into the study
Description

Illness Clinical Significance

Data type

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C2826293
participated in an investigational drug study within 30 days or 5 half-lives, whichever is longer, prior to the start of study medication
Description

Study Subject Participation Status | Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
history of clinically significant allergic drug reactions
Description

Drug Allergy

Data type

boolean

Alias
UMLS CUI [1]
C0013182

Similar models

Eligibility Hepatitis C NCT01727934

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Hepatitis C, Chronic
Item
diagnosis of chronic hepatitis c
boolean
C0524910 (UMLS CUI [1])
Hepatitis C virus genotype
Item
hcv genotype 1
boolean
C1533728 (UMLS CUI [1])
Body mass index
Item
bmi 18-38 kg/m2
boolean
C1305855 (UMLS CUI [1])
Therapy non-responder Pegylated interferon alfa | Therapy non-responder Ribavirin
Item
null responder to pegylated interferon alpha and ribavirin
boolean
C0919875 (UMLS CUI [1,1])
C0907160 (UMLS CUI [1,2])
C0919875 (UMLS CUI [2,1])
C0035525 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
HBV coinfection | HIV coinfection
Item
co-infection with hepatitis b virus (hbv) or human immunodeficiency virus (hiv)
boolean
C2242656 (UMLS CUI [1])
C4062778 (UMLS CUI [2])
Liver disease In addition to Hepatitis C
Item
significant liver disease in addition to hepatitis c
boolean
C0023895 (UMLS CUI [1,1])
C0332287 (UMLS CUI [1,2])
C0019196 (UMLS CUI [1,3])
Decompensated liver disease Medical History | Decompensated liver disease Features Clinical
Item
decompensated liver disease medical history or current clinical features
boolean
C4075847 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C4075847 (UMLS CUI [2,1])
C1521970 (UMLS CUI [2,2])
C0205210 (UMLS CUI [2,3])
Liver Cirrhosis
Item
histologic evidence of hepatic cirrhosis
boolean
C0023890 (UMLS CUI [1])
Comorbidity Clinical Significance | Exception Chronic Hepatitis C
Item
concurrent clinically significant medical diagnosis (other than chc)
boolean
C0009488 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0524910 (UMLS CUI [2,2])
Social Conditions Concurrent | Drug abuse | Alcohol intake above recommended sensible limits | Living conditions unsatisfactory
Item
concurrent social conditions (e.g. drugs of abuse, alcohol excess, poor living accommodation)
boolean
C0037403 (UMLS CUI [1,1])
C0205420 (UMLS CUI [1,2])
C0013146 (UMLS CUI [2])
C0560219 (UMLS CUI [3])
C0337630 (UMLS CUI [4])
Illness Clinical Significance
Item
clinically significant illness within 30 days preceding entry into the study
boolean
C0221423 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
Study Subject Participation Status | Investigational New Drugs
Item
participated in an investigational drug study within 30 days or 5 half-lives, whichever is longer, prior to the start of study medication
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Drug Allergy
Item
history of clinically significant allergic drug reactions
boolean
C0013182 (UMLS CUI [1])

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