ID

16659

Beschrijving

Induction Dosing With Pegylated Interferon Alfa 2a and Ribavirin in Patients With Chronic Hepatitis C Genotype 1; ODM derived from: https://clinicaltrials.gov/show/NCT00192647

Link

https://clinicaltrials.gov/show/NCT00192647

Trefwoorden

Versies (2)
  1. 30-07-16 30-07-16 -
  2. 17-09-21 17-09-21 -
Geüploaded op

30 juli 2016

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Chronic Hepatitis C NCT00192647

Engels

Eligibility Chronic Hepatitis C NCT00192647

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
male and female patients >18 and ≤75 years of age
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
serologic evidence of chronic hepatitis c infection (repeatedly anti-hcv positive and/or hcv-rna positive)
Beschrijving

Chronic Hepatitis C Evidence Serologic | Hepatitis C antibody positive | HCV viral load Positive

Datatype

boolean

Alias
UMLS CUI [1,1]
C0524910
UMLS CUI [1,2]
C0332120
UMLS CUI [1,3]
C0205473
UMLS CUI [2]
C0281863
UMLS CUI [3,1]
C1868902
UMLS CUI [3,2]
C1446409
hcv genotype 1
Beschrijving

Hepatitis C virus genotype

Datatype

boolean

Alias
UMLS CUI [1]
C1148363
liver biopsy consistent with chc (a maximum window of 3 years is permitted between biopsy and study enrolment)
Beschrijving

Biopsy of liver Consistent with Hepatitis C, Chronic

Datatype

boolean

Alias
UMLS CUI [1,1]
C0193388
UMLS CUI [1,2]
C0332290
UMLS CUI [1,3]
C0524910
compensated liver disease, child pugh score <7
Beschrijving

Compensated liver disease | Child-Pugh Classification

Datatype

boolean

Alias
UMLS CUI [1]
C3839044
UMLS CUI [2]
C2347612
serum hcv-rna >600 iu/ml
Beschrijving

HCV viral load Serum

Datatype

boolean

Alias
UMLS CUI [1,1]
C1868902
UMLS CUI [1,2]
C0229671
patients who are naïve to any hepatitis c therapy (i.e. have not been previously treated with an interferon or with ifn plus ribavirin)
Beschrijving

Therapy naive Hepatitis C | Interferons | Ribavirin

Datatype

boolean

Alias
UMLS CUI [1,1]
C0919936
UMLS CUI [1,2]
C0019196
UMLS CUI [2]
C0021747
UMLS CUI [3]
C0035525
no clinical or radiological evidence of hepatocellular carcinoma and a serum afp <100 ng/ml within 2 months of randomisation
Beschrijving

Liver carcinoma Evidence | serum alpha-fetoprotein (AFP) measurement

Datatype

boolean

Alias
UMLS CUI [1,1]
C2239176
UMLS CUI [1,2]
C3887511
UMLS CUI [2]
C0546833
negative urine or blood pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of study drug
Beschrijving

Childbearing Potential Urine pregnancy test negative | Childbearing Potential pregnancy blood test Negative | Investigational New Drugs

Datatype

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430057
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0850355
UMLS CUI [2,3]
C0205160
UMLS CUI [3]
C0013230
all fertile males and females receiving ribavirin must be using two forms of effective contraception during treatment and during the 6 months after treatment end
Beschrijving

Fertility Contraceptive methods | Ribavirin

Datatype

boolean

Alias
UMLS CUI [1,1]
C0015895
UMLS CUI [1,2]
C0700589
UMLS CUI [2]
C0035525
australian/new zealand sites only:
Beschrijving

Site australian | Site New Zealand

Datatype

boolean

Alias
UMLS CUI [1,1]
C0205145
UMLS CUI [1,2]
C0238711
UMLS CUI [2,1]
C0205145
UMLS CUI [2,2]
C0027978
patients are not required to have a liver biopsy
Beschrijving

Biopsy of liver Requirement

Datatype

boolean

Alias
UMLS CUI [1,1]
C0193388
UMLS CUI [1,2]
C1514873
must meet section 100 (aus) or pharmac (nz) requirements for treatment with peginterferon alfa-2a and ribavirin
Beschrijving

peginterferon alfa-2a | Ribavirin

Datatype

boolean

Alias
UMLS CUI [1]
C0391001
UMLS CUI [2]
C0035525
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
standard exclusion criteria for pegylated interferon and ribavirin.
Beschrijving

Exclusion Criteria Standard pegylated interferon alfa | Exclusion Criteria Standard Ribavirin

Datatype

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1442989
UMLS CUI [1,3]
C0907160
UMLS CUI [2,1]
C0680251
UMLS CUI [2,2]
C1442989
UMLS CUI [2,3]
C0035525
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Similar models

Eligibility Chronic Hepatitis C NCT00192647

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
male and female patients >18 and ≤75 years of age
boolean
C0001779 (UMLS CUI [1])
Chronic Hepatitis C Evidence Serologic | Hepatitis C antibody positive | HCV viral load Positive
Item
serologic evidence of chronic hepatitis c infection (repeatedly anti-hcv positive and/or hcv-rna positive)
boolean
C0524910 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
C0205473 (UMLS CUI [1,3])
C0281863 (UMLS CUI [2])
C1868902 (UMLS CUI [3,1])
C1446409 (UMLS CUI [3,2])
Hepatitis C virus genotype
Item
hcv genotype 1
boolean
C1148363 (UMLS CUI [1])
Biopsy of liver Consistent with Hepatitis C, Chronic
Item
liver biopsy consistent with chc (a maximum window of 3 years is permitted between biopsy and study enrolment)
boolean
C0193388 (UMLS CUI [1,1])
C0332290 (UMLS CUI [1,2])
C0524910 (UMLS CUI [1,3])
Compensated liver disease | Child-Pugh Classification
Item
compensated liver disease, child pugh score <7
boolean
C3839044 (UMLS CUI [1])
C2347612 (UMLS CUI [2])
HCV viral load Serum
Item
serum hcv-rna >600 iu/ml
boolean
C1868902 (UMLS CUI [1,1])
C0229671 (UMLS CUI [1,2])
Therapy naive Hepatitis C | Interferons | Ribavirin
Item
patients who are naïve to any hepatitis c therapy (i.e. have not been previously treated with an interferon or with ifn plus ribavirin)
boolean
C0919936 (UMLS CUI [1,1])
C0019196 (UMLS CUI [1,2])
C0021747 (UMLS CUI [2])
C0035525 (UMLS CUI [3])
Liver carcinoma Evidence | serum alpha-fetoprotein (AFP) measurement
Item
no clinical or radiological evidence of hepatocellular carcinoma and a serum afp <100 ng/ml within 2 months of randomisation
boolean
C2239176 (UMLS CUI [1,1])
C3887511 (UMLS CUI [1,2])
C0546833 (UMLS CUI [2])
Childbearing Potential Urine pregnancy test negative | Childbearing Potential pregnancy blood test Negative | Investigational New Drugs
Item
negative urine or blood pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of study drug
boolean
C3831118 (UMLS CUI [1,1])
C0430057 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0850355 (UMLS CUI [2,2])
C0205160 (UMLS CUI [2,3])
C0013230 (UMLS CUI [3])
Fertility Contraceptive methods | Ribavirin
Item
all fertile males and females receiving ribavirin must be using two forms of effective contraception during treatment and during the 6 months after treatment end
boolean
C0015895 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0035525 (UMLS CUI [2])
Site australian | Site New Zealand
Item
australian/new zealand sites only:
boolean
C0205145 (UMLS CUI [1,1])
C0238711 (UMLS CUI [1,2])
C0205145 (UMLS CUI [2,1])
C0027978 (UMLS CUI [2,2])
Biopsy of liver Requirement
Item
patients are not required to have a liver biopsy
boolean
C0193388 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
peginterferon alfa-2a | Ribavirin
Item
must meet section 100 (aus) or pharmac (nz) requirements for treatment with peginterferon alfa-2a and ribavirin
boolean
C0391001 (UMLS CUI [1])
C0035525 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Exclusion Criteria Standard pegylated interferon alfa | Exclusion Criteria Standard Ribavirin
Item
standard exclusion criteria for pegylated interferon and ribavirin.
boolean
C0680251 (UMLS CUI [1,1])
C1442989 (UMLS CUI [1,2])
C0907160 (UMLS CUI [1,3])
C0680251 (UMLS CUI [2,1])
C1442989 (UMLS CUI [2,2])
C0035525 (UMLS CUI [2,3])
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