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ID
39711
Description
An Observational Study of Pegasys (Peginterferon Alfa-2a) Plus Copegus (Ribavirin) in Patients With Chronic Hepatitis C, Genotype 2, 3, 1 or 4, Undergoing Opioid Maintenance Therapy (PEGHOPE); ODM derived from: https://clinicaltrials.gov/show/NCT01416610
Link
https://clinicaltrials.gov/show/NCT01416610
Keywords
Versions (1)
- 2/11/20 2/11/20 -
Copyright Holder
See clinicaltrials.gov
Uploaded on
February 11, 2020
DOI
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License
Creative Commons BY 4.0
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Eligibility Hepatitis C, Chronic NCT01416610
Eligibility Hepatitis C, Chronic NCT01416610
- StudyEvent: Eligibility
Similar models
Eligibility Hepatitis C, Chronic NCT01416610
- StudyEvent: Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Adult | Age
Item
adult patients, >/= 18 years of age
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0001779 (UMLS CUI [2])
Opioid Maintenance therapy
Item
patients undergoing an opioid maintenance therapy
boolean
C0242402 (UMLS CUI [1,1])
C0677908 (UMLS CUI [1,2])
C0677908 (UMLS CUI [1,2])
Serology positive Chronic Hepatitis C
Item
serologic evidence of chronic hepatitis c prior to therapy
boolean
C0242089 (UMLS CUI [1,1])
C0524910 (UMLS CUI [1,2])
C0524910 (UMLS CUI [1,2])
Chronic Hepatitis C Genotype
Item
chc genotype 1, 4, 2 or 3
boolean
C0524910 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
C1533728 (UMLS CUI [1,2])
Serum hepatitis c viral rna quantitative
Item
quantifiable serum hcv rna
boolean
C4272238 (UMLS CUI [1])
Females & males of reproductive potential Receiving Ribavirin | Females & males of reproductive potential Contraceptive methods Quantity
Item
all fertile males and females receiving ribavirin must use two forms of effective contraception during treatment with study drugs and for 7 months after completion of treatment
boolean
C4034483 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C0035525 (UMLS CUI [1,3])
C4034483 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C1514756 (UMLS CUI [1,2])
C0035525 (UMLS CUI [1,3])
C4034483 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
Psychoactive substance abuse Study Subject Participation Status Excluded | Alcohol intake above recommended sensible limits Study Subject Participation Status Excluded
Item
harmful use of psychoactive substances (including excessive alcohol consumption) that precludes successful participation in the study at the discretion of the investigator
boolean
C0033880 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0332196 (UMLS CUI [1,3])
C0560219 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C0332196 (UMLS CUI [2,3])
C2348568 (UMLS CUI [1,2])
C0332196 (UMLS CUI [1,3])
C0560219 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C0332196 (UMLS CUI [2,3])
PEGINTERFERON | Interferon | Ribavirin
Item
pegylated interferon, standard interferon or ribavirin therapy at any time prior to initiation of the study
boolean
C0982327 (UMLS CUI [1])
C3652465 (UMLS CUI [2])
C0035525 (UMLS CUI [3])
C3652465 (UMLS CUI [2])
C0035525 (UMLS CUI [3])
Coinfection Hepatitis A | HBV coinfection | Human immunodeficiency virus (HIV) coinfection
Item
co-infection with hepatitis a, hepatitis b or hiv
boolean
C0275524 (UMLS CUI [1,1])
C0019159 (UMLS CUI [1,2])
C2242656 (UMLS CUI [2])
C4062778 (UMLS CUI [3])
C0019159 (UMLS CUI [1,2])
C2242656 (UMLS CUI [2])
C4062778 (UMLS CUI [3])
Major Depressive Disorder | Psychotic Disorder
Item
current diagnosis of a major depression or any psychotic disorder
boolean
C1269683 (UMLS CUI [1])
C0033975 (UMLS CUI [2])
C0033975 (UMLS CUI [2])