ID

39651

Beschrijving

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

Trefwoorden

  1. 08-02-20 08-02-20 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

8 februari 2020

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Hepatitis C NCT01727934

Eligibility Hepatitis C NCT01727934

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of chronic hepatitis c
Beschrijving

Hepatitis C, Chronic

Datatype

boolean

Alias
UMLS CUI [1]
C0524910
hcv genotype 1
Beschrijving

Hepatitis C virus genotype

Datatype

boolean

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

Body mass index

Datatype

boolean

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

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

Datatype

boolean

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

Exclusion Criteria

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

HBV coinfection | HIV coinfection

Datatype

boolean

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

Liver disease In addition to Hepatitis C

Datatype

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
Beschrijving

Decompensated liver disease Medical History | Decompensated liver disease Features Clinical

Datatype

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
Beschrijving

Liver Cirrhosis

Datatype

boolean

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

Comorbidity Clinical Significance | Exception Chronic Hepatitis C

Datatype

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)
Beschrijving

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

Datatype

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
Beschrijving

Illness Clinical Significance

Datatype

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
Beschrijving

Study Subject Participation Status | Investigational New Drugs

Datatype

boolean

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

Drug Allergy

Datatype

boolean

Alias
UMLS CUI [1]
C0013182

Similar models

Eligibility Hepatitis C NCT01727934

Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])

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