ID

39711

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT01416610

Nyckelord

  1. 2020-02-11 2020-02-11 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

11 februari 2020

DOI

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Licens

Creative Commons BY 4.0

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Eligibility Hepatitis C, Chronic NCT01416610

Eligibility Hepatitis C, Chronic NCT01416610

Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult patients, >/= 18 years of age
Beskrivning

Adult | Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
patients undergoing an opioid maintenance therapy
Beskrivning

Opioid Maintenance therapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0242402
UMLS CUI [1,2]
C0677908
serologic evidence of chronic hepatitis c prior to therapy
Beskrivning

Serology positive Chronic Hepatitis C

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0242089
UMLS CUI [1,2]
C0524910
chc genotype 1, 4, 2 or 3
Beskrivning

Chronic Hepatitis C Genotype

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0524910
UMLS CUI [1,2]
C1533728
quantifiable serum hcv rna
Beskrivning

Serum hepatitis c viral rna quantitative

Datatyp

boolean

Alias
UMLS CUI [1]
C4272238
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
Beskrivning

Females & males of reproductive potential Receiving Ribavirin | Females & males of reproductive potential Contraceptive methods Quantity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C4034483
UMLS CUI [1,2]
C1514756
UMLS CUI [1,3]
C0035525
UMLS CUI [2,1]
C4034483
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C1265611
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
harmful use of psychoactive substances (including excessive alcohol consumption) that precludes successful participation in the study at the discretion of the investigator
Beskrivning

Psychoactive substance abuse Study Subject Participation Status Excluded | Alcohol intake above recommended sensible limits Study Subject Participation Status Excluded

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0033880
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C0332196
UMLS CUI [2,1]
C0560219
UMLS CUI [2,2]
C2348568
UMLS CUI [2,3]
C0332196
pegylated interferon, standard interferon or ribavirin therapy at any time prior to initiation of the study
Beskrivning

PEGINTERFERON | Interferon | Ribavirin

Datatyp

boolean

Alias
UMLS CUI [1]
C0982327
UMLS CUI [2]
C3652465
UMLS CUI [3]
C0035525
co-infection with hepatitis a, hepatitis b or hiv
Beskrivning

Coinfection Hepatitis A | HBV coinfection | Human immunodeficiency virus (HIV) coinfection

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0275524
UMLS CUI [1,2]
C0019159
UMLS CUI [2]
C2242656
UMLS CUI [3]
C4062778
current diagnosis of a major depression or any psychotic disorder
Beskrivning

Major Depressive Disorder | Psychotic Disorder

Datatyp

boolean

Alias
UMLS CUI [1]
C1269683
UMLS CUI [2]
C0033975

Similar models

Eligibility Hepatitis C, Chronic NCT01416610

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Age
Item
adult patients, >/= 18 years of age
boolean
C0001675 (UMLS CUI [1])
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])
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])
Chronic Hepatitis C Genotype
Item
chc genotype 1, 4, 2 or 3
boolean
C0524910 (UMLS CUI [1,1])
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])
Item Group
C0680251 (UMLS CUI)
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])
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])
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])
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])

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