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ID
16659
Beschreibung
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
Stichworte
Versionen (2)
- 30.07.16 30.07.16 -
- 17.09.21 17.09.21 -
Hochgeladen am
30. Juli 2016
DOI
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Lizenz
Creative Commons BY 4.0
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Eligibility Chronic Hepatitis C NCT00192647
Eligibility Chronic Hepatitis C NCT00192647
- StudyEvent: Eligibility
Ähnliche Modelle
Eligibility Chronic Hepatitis C NCT00192647
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
C0035525 (UMLS CUI [2])
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])
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])