ID

17515

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT00097435

Nyckelord

  1. 2016-09-20 2016-09-20 -
Uppladdad den

20 september 2016

DOI

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Licens

Creative Commons BY 4.0

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Eligibility Hepatitis C NCT00097435

Eligibility Hepatitis C NCT00097435

Criteria
Beskrivning

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.
Beskrivning

Hepatitis C, Chronic | HCV viral load

Datatyp

boolean

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

Interferon-alpha Unresponsive to Treatment

Datatyp

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.
Beskrivning

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

Datatyp

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:
Beskrivning

Exclusion Criteria Major

Datatyp

boolean

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

Decompensated cirrhosis Evidence of | Portal Hypertension Evidence of

Datatyp

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.
Beskrivning

Pregnancy | Breast Feeding

Datatyp

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.
Beskrivning

Disease Patient Inappropriate Clinical Trial | Condition Patient Inappropriate Clinical Trial

Datatyp

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
Beskrivning

Substance Dependence

Datatyp

boolean

Alias
UMLS CUI [1]
C0038580

Similar models

Eligibility Hepatitis C NCT00097435

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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