ID

39738

Description

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

Keywords

Versions (1)
  1. 2/14/20 2/14/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 14, 2020

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Hepatitis C, Chronic NCT01798576

English

Eligibility Hepatitis C, Chronic NCT01798576

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

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

Adult | Age

Data type

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
Description

Prior Therapy Chronic Hepatitis C | PEGINTERFERON | Interferon | Ribavirin

Data type

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
Description

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

Data type

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:
Description

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

Data type

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
Description

Hepatitis C RNA positive Serum

Data type

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
Description

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

Data type

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
Description

HBV coinfection Absent | HIV coinfection Absent

Data type

boolean

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

Exclusion Criteria

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

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

Data type

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
Description

Nervous system disorder

Data type

boolean

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

Mental Disorder, Severe

Data type

boolean

Alias
UMLS CUI [1]
C4046029
decompensated diabetes
Description

Decompensated diabetes

Data type

boolean

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

Disease Immune-mediated

Data type

boolean

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

Heart Disease Severe

Data type

boolean

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

Severe chronic lung disease

Data type

boolean

Alias
UMLS CUI [1]
C3278799
inadequate hematologic function
Description

Hematologic function Inadequate

Data type

boolean

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

Pregnancy | Breast Feeding

Data type

boolean

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

Gender Partner Pregnancy

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0682323
UMLS CUI [1,3]
C0032961
Back to the top of the page

Similar models

Eligibility Hepatitis C, Chronic NCT01798576

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial