ID

17515

Description

A Study of Albuferon With Ribavirin in Interferon Treatment Experienced Subjects With Chronic Hepatitis C; ODM derived from: https://clinicaltrials.gov/show/NCT00097435

Lien

https://clinicaltrials.gov/show/NCT00097435

Mots-clés

  1. 20/09/2016 20/09/2016 -
Téléchargé le

20 septembre 2016

DOI

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Licence

Creative Commons BY 4.0

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Eligibility Hepatitis C NCT00097435

Eligibility Hepatitis C NCT00097435

Criteria
Description

Criteria

have a clinical diagnosis of chronic hep c established on the basis of detectable viral load, as measured by a serum hcv rna test during the screening period.
Description

Hepatitis C, Chronic | HCV viral load

Type de données

boolean

Alias
UMLS CUI [1]
C0524910
UMLS CUI [2]
C1868902
have previously failed to respond to treatment with any interferon alfa (ifna) product
Description

Interferon-alpha Unresponsive to Treatment

Type de données

boolean

Alias
UMLS CUI [1,1]
C0002199
UMLS CUI [1,2]
C0205269
have compensated liver disease with the following minimum criteria: white blood cell count > 3,000/mm3, absolute neutrophil count (anc) > 2,000/mm3, platelets > 125,000/mm3, and hemoglobin (hb) > 13 g/dl for males or > 12 g/dl for females.
Description

Compensated liver disease | White Blood Cell Count procedure | Absolute neutrophil count | Platelet Count measurement | Hemoglobin | Gender

Type de données

boolean

Alias
UMLS CUI [1]
C3839044
UMLS CUI [2]
C0023508
UMLS CUI [3]
C0948762
UMLS CUI [4]
C0032181
UMLS CUI [5]
C0019046
UMLS CUI [6]
C0079399
major exclusion criteria:
Description

Exclusion Criteria Major

Type de données

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0205164
evidence of decompensated cirrhosis or portal hypertension.
Description

Decompensated cirrhosis Evidence of | Portal Hypertension Evidence of

Type de données

boolean

Alias
UMLS CUI [1,1]
C1619727
UMLS CUI [1,2]
C0332120
UMLS CUI [2,1]
C0020541
UMLS CUI [2,2]
C0332120
pregnant or lactating female.
Description

Pregnancy | Breast Feeding

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
history of any other medical disease or condition that would make the subject (in the opinion of the investigator) unsuitable for the study.
Description

Disease Patient Inappropriate Clinical Trial | Condition Patient Inappropriate Clinical Trial

Type de données

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0030705
UMLS CUI [1,3]
C1548788
UMLS CUI [1,4]
C0008976
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0030705
UMLS CUI [2,3]
C1548788
UMLS CUI [2,4]
C0008976
a current drug or alcohol addiction
Description

Substance Dependence

Type de données

boolean

Alias
UMLS CUI [1]
C0038580

Similar models

Eligibility Hepatitis C NCT00097435

Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Hepatitis C, Chronic | HCV viral load
Item
have a clinical diagnosis of chronic hep c established on the basis of detectable viral load, as measured by a serum hcv rna test during the screening period.
boolean
C0524910 (UMLS CUI [1])
C1868902 (UMLS CUI [2])
Interferon-alpha Unresponsive to Treatment
Item
have previously failed to respond to treatment with any interferon alfa (ifna) product
boolean
C0002199 (UMLS CUI [1,1])
C0205269 (UMLS CUI [1,2])
Compensated liver disease | White Blood Cell Count procedure | Absolute neutrophil count | Platelet Count measurement | Hemoglobin | Gender
Item
have compensated liver disease with the following minimum criteria: white blood cell count > 3,000/mm3, absolute neutrophil count (anc) > 2,000/mm3, platelets > 125,000/mm3, and hemoglobin (hb) > 13 g/dl for males or > 12 g/dl for females.
boolean
C3839044 (UMLS CUI [1])
C0023508 (UMLS CUI [2])
C0948762 (UMLS CUI [3])
C0032181 (UMLS CUI [4])
C0019046 (UMLS CUI [5])
C0079399 (UMLS CUI [6])
Exclusion Criteria Major
Item
major exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
Decompensated cirrhosis Evidence of | Portal Hypertension Evidence of
Item
evidence of decompensated cirrhosis or portal hypertension.
boolean
C1619727 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
C0020541 (UMLS CUI [2,1])
C0332120 (UMLS CUI [2,2])
Pregnancy | Breast Feeding
Item
pregnant or lactating female.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Disease Patient Inappropriate Clinical Trial | Condition Patient Inappropriate Clinical Trial
Item
history of any other medical disease or condition that would make the subject (in the opinion of the investigator) unsuitable for the study.
boolean
C0012634 (UMLS CUI [1,1])
C0030705 (UMLS CUI [1,2])
C1548788 (UMLS CUI [1,3])
C0008976 (UMLS CUI [1,4])
C0348080 (UMLS CUI [2,1])
C0030705 (UMLS CUI [2,2])
C1548788 (UMLS CUI [2,3])
C0008976 (UMLS CUI [2,4])
Substance Dependence
Item
a current drug or alcohol addiction
boolean
C0038580 (UMLS CUI [1])

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