ID

39741

Beschrijving

Miravirsen in Combination With Telaprevir and Ribavirin in Null Responder to Pegylated-Interferon Alpha Plus Ribavirin Subjects With Chronic Hepatitis C Virus Infection; ODM derived from: https://clinicaltrials.gov/show/NCT01872936

Link

https://clinicaltrials.gov/show/NCT01872936

Trefwoorden

  1. 14-02-20 14-02-20 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

14 februari 2020

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Hepatitis C, Chronic NCT01872936

Eligibility Hepatitis C, Chronic NCT01872936

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of chronic hepatitis c genotype 1 infection
Beschrijving

Chronic Hepatitis C Genotype

Datatype

boolean

Alias
UMLS CUI [1,1]
C0524910
UMLS CUI [1,2]
C1533728
bmi 18 and 38 kg/m2
Beschrijving

Body mass index

Datatype

boolean

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

Non-responder Peginterferon alfa-2a | Non-responder Peginterferon alfa-2b | Non-responder Ribavirin

Datatype

boolean

Alias
UMLS CUI [1,1]
C0919875
UMLS CUI [1,2]
C0391001
UMLS CUI [2,1]
C0919875
UMLS CUI [2,2]
C0796545
UMLS CUI [3,1]
C0919875
UMLS CUI [3,2]
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 | Human immunodeficiency virus (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

Datatype

boolean

Alias
UMLS CUI [1]
C4075847
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 CONDITION POOR

Datatype

boolean

Alias
UMLS CUI [1,1]
C0037403
UMLS CUI [1,2]
C0205420
UMLS CUI [2]
C0013146
UMLS CUI [3]
C0560219
UMLS CUI [4]
C0745770
clinically significant illness within 30 days preceding entry into the study
Beschrijving

Illness Clinical Significance Recent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C2826293
UMLS CUI [1,3]
C0332185
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, Chronic NCT01872936

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Chronic Hepatitis C Genotype
Item
diagnosis of chronic hepatitis c genotype 1 infection
boolean
C0524910 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
Body mass index
Item
bmi 18 and 38 kg/m2
boolean
C1305855 (UMLS CUI [1])
Non-responder Peginterferon alfa-2a | Non-responder Peginterferon alfa-2b | Non-responder Ribavirin
Item
null responder to pegylated interferon alpha and ribavirin
boolean
C0919875 (UMLS CUI [1,1])
C0391001 (UMLS CUI [1,2])
C0919875 (UMLS CUI [2,1])
C0796545 (UMLS CUI [2,2])
C0919875 (UMLS CUI [3,1])
C0035525 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
HBV coinfection | Human immunodeficiency virus (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
Item
decompensated liver disease medical history or current clinical features
boolean
C4075847 (UMLS CUI [1])
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 CONDITION POOR
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])
C0745770 (UMLS CUI [4])
Illness Clinical Significance Recent
Item
clinically significant illness within 30 days preceding entry into the study
boolean
C0221423 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
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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