ID

39726

Description

A Triple Combination Therapy Study of Boceprevir, Pegasys and Copegus in Previously Untreated Patients With Genotype 1 Chronic Hepatitis C; ODM derived from: https://clinicaltrials.gov/show/NCT01591460

Link

https://clinicaltrials.gov/show/NCT01591460

Keywords

Versions (2)
  1. 2/13/20 2/13/20 -
  2. 9/20/21 9/20/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 13, 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 NCT01591460

English

Eligibility Hepatitis C, Chronic NCT01591460

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
chronic liver disease consistent with chronic hepatitis c, genotype 1 infection
Description

Chronic liver disease Consistent with Chronic Hepatitis C Genotype

Data type

boolean

Alias
UMLS CUI [1,1]
C0341439
UMLS CUI [1,2]
C0332290
UMLS CUI [1,3]
C0524910
UMLS CUI [1,4]
C1533728
serum hcv rna quantifiable at screening
Description

Serum hepatitis c viral rna quantitative

Data type

boolean

Alias
UMLS CUI [1]
C4272238
patients who have not been previously treated with pegylated interferon (ifn), standard ifn, rbv or any direct acting anti-viral agent
Description

PEGINTERFERON Absent | Interferon Absent | Ribavirin Absent | DIRECT ACTING ANTIVIRALS Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0982327
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C3652465
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0035525
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C3653501
UMLS CUI [4,2]
C0332197
compensated liver disease (child-pugh grade a clinical classification for patients with cirrhosis: total score </=6)
Description

Compensated liver disease Child-Pugh Classification | Patients Liver Cirrhosis | Compensated liver disease Child-Pugh - Total Score

Data type

boolean

Alias
UMLS CUI [1,1]
C3839044
UMLS CUI [1,2]
C2347612
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C0023890
UMLS CUI [3,1]
C3839044
UMLS CUI [3,2]
C4055253
negative urine or blood pregnancy test (for women of childbearing potential)
Description

Childbearing Potential Urine pregnancy test negative | Childbearing Potential Pregnancy blood test Negative

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430057
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0850355
UMLS CUI [2,3]
C1513916
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
women with ongoing pregnancy or breast feeding
Description

Pregnancy | Breast Feeding

Data type

boolean

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

Gender Partner Pregnancy

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0682323
UMLS CUI [1,3]
C0032961
therapy with any systemic anti-viral, anti-neoplastic or immunomodulatory treatment </=6 months prior to the first dose of study drug
Description

Antiviral Therapy Systemic | Antineoplastic Agents Systemic | Immunomodulatory therapy Systemic

Data type

boolean

Alias
UMLS CUI [1,1]
C0280274
UMLS CUI [1,2]
C0205373
UMLS CUI [2,1]
C0003392
UMLS CUI [2,2]
C0205373
UMLS CUI [3,1]
C1963758
UMLS CUI [3,2]
C0205373
any investigational drug </=6 weeks prior to the first dose of study drug
Description

Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013230
history or other evidence of decompensated liver disease
Description

Decompensated liver disease

Data type

boolean

Alias
UMLS CUI [1]
C4075847
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
signs or symptoms of hepatocellular carcinoma
Description

Sign or Symptom Liver carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C3540840
UMLS CUI [1,2]
C2239176
co-infection with hcv genotypes other than genotype 1
Description

HCV coinfection Genotype | Exception Hepatitis C virus genotype determination

Data type

boolean

Alias
UMLS CUI [1,1]
C1698259
UMLS CUI [1,2]
C1148363
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1533728
co-infection with hepatitis a, hepatitis b, and/or human immunodeficiency virus (hiv)
Description

Coinfection Hepatitis A | HBV coinfection | HIV coinfection

Data type

boolean

Alias
UMLS CUI [1,1]
C0275524
UMLS CUI [1,2]
C0019159
UMLS CUI [2]
C2242656
UMLS CUI [3]
C4062778
any patient with an increased risk for anemia
Description

High risk of Anemia

Data type

boolean

Alias
UMLS CUI [1,1]
C0332167
UMLS CUI [1,2]
C0002871
history of severe psychiatric disease
Description

Mental Disorders, Severe

Data type

boolean

Alias
UMLS CUI [1]
C4046029
history of immunologically mediated, chronic pulmonary, or severe cardiac disease
Description

Disease Immune-mediated | Chronic lung disease | Heart Disease Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C4330477
UMLS CUI [2]
C0746102
UMLS CUI [3,1]
C0018799
UMLS CUI [3,2]
C0205082
current diseases that are not adequately controlled
Description

Disease Poorly controlled

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C3853134
Back to the top of the page

Similar models

Eligibility Hepatitis C, Chronic NCT01591460

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])
Chronic liver disease Consistent with Chronic Hepatitis C Genotype
Item
chronic liver disease consistent with chronic hepatitis c, genotype 1 infection
boolean
C0341439 (UMLS CUI [1,1])
C0332290 (UMLS CUI [1,2])
C0524910 (UMLS CUI [1,3])
C1533728 (UMLS CUI [1,4])
Serum hepatitis c viral rna quantitative
Item
serum hcv rna quantifiable at screening
boolean
C4272238 (UMLS CUI [1])
PEGINTERFERON Absent | Interferon Absent | Ribavirin Absent | DIRECT ACTING ANTIVIRALS Absent
Item
patients who have not been previously treated with pegylated interferon (ifn), standard ifn, rbv or any direct acting anti-viral agent
boolean
C0982327 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C3652465 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0035525 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C3653501 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Compensated liver disease Child-Pugh Classification | Patients Liver Cirrhosis | Compensated liver disease Child-Pugh - Total Score
Item
compensated liver disease (child-pugh grade a clinical classification for patients with cirrhosis: total score </=6)
boolean
C3839044 (UMLS CUI [1,1])
C2347612 (UMLS CUI [1,2])
C0030705 (UMLS CUI [2,1])
C0023890 (UMLS CUI [2,2])
C3839044 (UMLS CUI [3,1])
C4055253 (UMLS CUI [3,2])
Childbearing Potential Urine pregnancy test negative | Childbearing Potential Pregnancy blood test Negative
Item
negative urine or blood pregnancy test (for women of childbearing potential)
boolean
C3831118 (UMLS CUI [1,1])
C0430057 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0850355 (UMLS CUI [2,2])
C1513916 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
women with ongoing pregnancy or breast feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Gender Partner Pregnancy
Item
male partners of women who are pregnant
boolean
C0079399 (UMLS CUI [1,1])
C0682323 (UMLS CUI [1,2])
C0032961 (UMLS CUI [1,3])
Antiviral Therapy Systemic | Antineoplastic Agents Systemic | Immunomodulatory therapy Systemic
Item
therapy with any systemic anti-viral, anti-neoplastic or immunomodulatory treatment </=6 months prior to the first dose of study drug
boolean
C0280274 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C0003392 (UMLS CUI [2,1])
C0205373 (UMLS CUI [2,2])
C1963758 (UMLS CUI [3,1])
C0205373 (UMLS CUI [3,2])
Investigational New Drugs
Item
any investigational drug </=6 weeks prior to the first dose of study drug
boolean
C0013230 (UMLS CUI [1])
Decompensated liver disease
Item
history or other evidence of decompensated liver disease
boolean
C4075847 (UMLS CUI [1])
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])
Sign or Symptom Liver carcinoma
Item
signs or symptoms of hepatocellular carcinoma
boolean
C3540840 (UMLS CUI [1,1])
C2239176 (UMLS CUI [1,2])
HCV coinfection Genotype | Exception Hepatitis C virus genotype determination
Item
co-infection with hcv genotypes other than genotype 1
boolean
C1698259 (UMLS CUI [1,1])
C1148363 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C1533728 (UMLS CUI [2,2])
Coinfection Hepatitis A | HBV coinfection | HIV coinfection
Item
co-infection with hepatitis a, hepatitis b, and/or human immunodeficiency virus (hiv)
boolean
C0275524 (UMLS CUI [1,1])
C0019159 (UMLS CUI [1,2])
C2242656 (UMLS CUI [2])
C4062778 (UMLS CUI [3])
High risk of Anemia
Item
any patient with an increased risk for anemia
boolean
C0332167 (UMLS CUI [1,1])
C0002871 (UMLS CUI [1,2])
Mental Disorders, Severe
Item
history of severe psychiatric disease
boolean
C4046029 (UMLS CUI [1])
Disease Immune-mediated | Chronic lung disease | Heart Disease Severe
Item
history of immunologically mediated, chronic pulmonary, or severe cardiac disease
boolean
C0012634 (UMLS CUI [1,1])
C4330477 (UMLS CUI [1,2])
C0746102 (UMLS CUI [2])
C0018799 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
Disease Poorly controlled
Item
current diseases that are not adequately controlled
boolean
C0012634 (UMLS CUI [1,1])
C3853134 (UMLS CUI [1,2])
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