ID

39738

Descripción

An Observational Study of Pegasys (Peginterferon Alfa-2a) Plus Ribavirin Based Regimens in Patients With Chronic Hepatitis C With Previous Treatment Failure; ODM derived from: https://clinicaltrials.gov/show/NCT01798576

Link

https://clinicaltrials.gov/show/NCT01798576

Palabras clave

Versiones (1)
  1. 14/2/20 14/2/20 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

14 de febrero de 2020

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Hepatitis C, Chronic NCT01798576

Inglés

Eligibility Hepatitis C, Chronic NCT01798576

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

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

Adult | Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
patients with chronic hepatitis c who have been previously treated with pegylated interferon, standard interferon, ribavirin
Descripción

Prior Therapy Chronic Hepatitis C | PEGINTERFERON | Interferon | Ribavirin

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0524910
UMLS CUI [2]
C0982327
UMLS CUI [3]
C3652465
UMLS CUI [4]
C0035525
no contra-indications to pegylated interferon and ribavirin therapy or to the treatment regimen containing daas as detailed in the local label
Descripción

Medical contraindication Absent PEGINTERFERON | Medical contraindication Absent Ribavirin | Medical contraindication Absent DIRECT ACTING ANTIVIRALS

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0982327
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0035525
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C0332197
UMLS CUI [3,3]
C3653501
treatment in line with summary of product characteristics/local labeling for pegasys/ribavirin and daas, in particular:
Descripción

Therapeutic procedure Consistent with Pegasys | Therapeutic procedure Consistent with Ribavirin | Therapeutic procedure Consistent with DIRECT ACTING ANTIVIRALS

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0332290
UMLS CUI [1,3]
C1176430
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0332290
UMLS CUI [2,3]
C0035525
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C0332290
UMLS CUI [3,3]
C3653501
positive serum hcv rna
Descripción

Hepatitis C RNA positive Serum

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0855842
UMLS CUI [1,2]
C0229671
fertile males and females receiving ribavirin must use two forms of contraception during treatment with pegasys/ribavirin and until 6 months post-treatment
Descripción

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

Tipo de datos

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
no co-infection with hepatitis b or hiv
Descripción

HBV coinfection Absent | HIV coinfection Absent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2242656
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C4062778
UMLS CUI [2,2]
C0332197
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
history or other evidence of a medical condition associated with chronic liver disease other than chronic hepatitis c
Descripción

Medical condition Associated with Chronic liver disease | Exception Chronic Hepatitis C

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C0341439
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0524910
history of neurological disease
Descripción

Nervous system disorder

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0027765
history of severe psychiatric disease
Descripción

Mental Disorder, Severe

Tipo de datos

boolean

Alias
UMLS CUI [1]
C4046029
decompensated diabetes
Descripción

Decompensated diabetes

Tipo de datos

boolean

Alias
UMLS CUI [1]
C4324690
history of immunologically mediated disease
Descripción

Disease Immune-mediated

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C4330477
history of severe cardiac disease
Descripción

Heart Disease Severe

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0205082
history or evidence of severe chronic pulmonary disease
Descripción

Severe chronic lung disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3278799
inadequate hematologic function
Descripción

Hematologic function Inadequate

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0221130
UMLS CUI [1,2]
C0205412
pregnant or breastfeeding women
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
male partners of pregnant women
Descripción

Gender Partner Pregnancy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0682323
UMLS CUI [1,3]
C0032961
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Similar models

Eligibility Hepatitis C, Chronic NCT01798576

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Age
Item
adult patients, >/= 18 years of age
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Prior Therapy Chronic Hepatitis C | PEGINTERFERON | Interferon | Ribavirin
Item
patients with chronic hepatitis c who have been previously treated with pegylated interferon, standard interferon, ribavirin
boolean
C1514463 (UMLS CUI [1,1])
C0524910 (UMLS CUI [1,2])
C0982327 (UMLS CUI [2])
C3652465 (UMLS CUI [3])
C0035525 (UMLS CUI [4])
Medical contraindication Absent PEGINTERFERON | Medical contraindication Absent Ribavirin | Medical contraindication Absent DIRECT ACTING ANTIVIRALS
Item
no contra-indications to pegylated interferon and ribavirin therapy or to the treatment regimen containing daas as detailed in the local label
boolean
C1301624 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0982327 (UMLS CUI [1,3])
C1301624 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0035525 (UMLS CUI [2,3])
C1301624 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C3653501 (UMLS CUI [3,3])
Therapeutic procedure Consistent with Pegasys | Therapeutic procedure Consistent with Ribavirin | Therapeutic procedure Consistent with DIRECT ACTING ANTIVIRALS
Item
treatment in line with summary of product characteristics/local labeling for pegasys/ribavirin and daas, in particular:
boolean
C0087111 (UMLS CUI [1,1])
C0332290 (UMLS CUI [1,2])
C1176430 (UMLS CUI [1,3])
C0087111 (UMLS CUI [2,1])
C0332290 (UMLS CUI [2,2])
C0035525 (UMLS CUI [2,3])
C0087111 (UMLS CUI [3,1])
C0332290 (UMLS CUI [3,2])
C3653501 (UMLS CUI [3,3])
Hepatitis C RNA positive Serum
Item
positive serum hcv rna
boolean
C0855842 (UMLS CUI [1,1])
C0229671 (UMLS CUI [1,2])
Females & males of reproductive potential Receiving Ribavirin | Females & males of reproductive potential Contraceptive methods Quantity
Item
fertile males and females receiving ribavirin must use two forms of contraception during treatment with pegasys/ribavirin and until 6 months post-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])
HBV coinfection Absent | HIV coinfection Absent
Item
no co-infection with hepatitis b or hiv
boolean
C2242656 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C4062778 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Medical condition Associated with Chronic liver disease | Exception Chronic Hepatitis C
Item
history or other evidence of a medical condition associated with chronic liver disease other than chronic hepatitis c
boolean
C3843040 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0341439 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0524910 (UMLS CUI [2,2])
Nervous system disorder
Item
history of neurological disease
boolean
C0027765 (UMLS CUI [1])
Mental Disorder, Severe
Item
history of severe psychiatric disease
boolean
C4046029 (UMLS CUI [1])
Decompensated diabetes
Item
decompensated diabetes
boolean
C4324690 (UMLS CUI [1])
Disease Immune-mediated
Item
history of immunologically mediated disease
boolean
C0012634 (UMLS CUI [1,1])
C4330477 (UMLS CUI [1,2])
Heart Disease Severe
Item
history of severe cardiac disease
boolean
C0018799 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Severe chronic lung disease
Item
history or evidence of severe chronic pulmonary disease
boolean
C3278799 (UMLS CUI [1])
Hematologic function Inadequate
Item
inadequate hematologic function
boolean
C0221130 (UMLS CUI [1,1])
C0205412 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
pregnant or breastfeeding women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Gender Partner Pregnancy
Item
male partners of pregnant women
boolean
C0079399 (UMLS CUI [1,1])
C0682323 (UMLS CUI [1,2])
C0032961 (UMLS CUI [1,3])
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