ID

44413

Description

Tailored Regimens of PEGASYS® and Ribavirin for Genotype 1 Chronic Hepatitis C Patients Trial (TARGET-1); ODM derived from: https://clinicaltrials.gov/show/NCT01937728

Link

https://clinicaltrials.gov/show/NCT01937728

Keywords

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

See clinicaltrials.gov

Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatitis C NCT01937728

English

Eligibility Hepatitis C NCT01937728

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
male and female patients *18 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
patients have never been treated with traditional interferon plus ribavirin or peginterferon plus ribavirin
Description

Ribavirin+interferon alpha-2b Absent | PEGINTERFERON/RIBAVIRIN Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0717864
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C1875630
UMLS CUI [2,2]
C0332197
serologic evidence of chronic hepatitis c infection by an anti-hcv antibody test
Description

Serology positive Chronic Hepatitis C | Hepatitis C antibody test

Data type

boolean

Alias
UMLS CUI [1,1]
C0242089
UMLS CUI [1,2]
C0524910
UMLS CUI [2]
C0201487
detectable serum hcv-rna and hcv viral genotype 1
Description

Hepatitis C virus RNA Serum Detectable | Hepatitis C virus Genotype Detectable

Data type

boolean

Alias
UMLS CUI [1,1]
C0369335
UMLS CUI [1,2]
C0229671
UMLS CUI [1,3]
C3830527
UMLS CUI [2,1]
C1533728
UMLS CUI [2,2]
C3830527
liver biopsy findings consistent with the diagnosis of chronic hepatitis c infection with or without compensated cirrhosis (exception: hemophiliacs in whom biopsy is medically contra-indicated do not require biopsy.)
Description

Biopsy of liver Consistent with Chronic Hepatitis C | Compensated cirrhosis | Compensated cirrhosis Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0193388
UMLS CUI [1,2]
C0332290
UMLS CUI [1,3]
C0524910
UMLS CUI [2]
C1608426
UMLS CUI [3,1]
C1608426
UMLS CUI [3,2]
C0332197
compensated liver disease (child-pugh grade a clinical classification)
Description

Compensated liver disease Child-Pugh Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C3839044
UMLS CUI [1,2]
C4050412
negative urine or blood pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of study drug
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
all fertile males and females receiving ribavirin must be using two forms of effective contraception during treatment and during the 6 months after treatment end
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
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
therapy with any systemic anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) *6 months prior to the first dose of study drug
Description

Antineoplastic Therapy Systemic | Immunomodulatory therapy | Steroid therapy | Therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C2346834
UMLS CUI [1,2]
C0205373
UMLS CUI [2]
C1963758
UMLS CUI [3]
C0149783
UMLS CUI [4]
C1522449
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
co-infection with active hepatitis a, hepatitis b and/or human immunodeficiency virus (hiv)
Description

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

Data type

boolean

Alias
UMLS CUI [1,1]
C0275524
UMLS CUI [1,2]
C0019159
UMLS CUI [2]
C2242656
UMLS CUI [3]
C4062778
history or other evidence of a medical condition associated with chronic liver disease other than hcv (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures)
Description

Medical condition Associated with Chronic liver disease | Exception Hepatitis C | Hemochromatosis | Hepatitis, Autoimmune | Liver disease Metabolic | Alcoholic Liver Diseases | Exposure to toxin

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]
C0019196
UMLS CUI [3]
C0018995
UMLS CUI [4]
C0241910
UMLS CUI [5,1]
C0023895
UMLS CUI [5,2]
C0311400
UMLS CUI [6]
C0023896
UMLS CUI [7]
C0040537
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
history or other evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease
Description

Bleeding esophageal varices | Condition Consistent with Decompensated liver disease

Data type

boolean

Alias
UMLS CUI [1]
C0155789
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0332290
UMLS CUI [2,3]
C4075847
neutrophil count <1500 cells/mm3 or platelet count <90,000 cells/mm3 at screening
Description

Neutrophil count | Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0200633
UMLS CUI [2]
C0032181
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Similar models

Eligibility Hepatitis C NCT01937728

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
male and female patients *18 years of age
boolean
C0001779 (UMLS CUI [1])
Ribavirin+interferon alpha-2b Absent | PEGINTERFERON/RIBAVIRIN Absent
Item
patients have never been treated with traditional interferon plus ribavirin or peginterferon plus ribavirin
boolean
C0717864 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1875630 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Serology positive Chronic Hepatitis C | Hepatitis C antibody test
Item
serologic evidence of chronic hepatitis c infection by an anti-hcv antibody test
boolean
C0242089 (UMLS CUI [1,1])
C0524910 (UMLS CUI [1,2])
C0201487 (UMLS CUI [2])
Hepatitis C virus RNA Serum Detectable | Hepatitis C virus Genotype Detectable
Item
detectable serum hcv-rna and hcv viral genotype 1
boolean
C0369335 (UMLS CUI [1,1])
C0229671 (UMLS CUI [1,2])
C3830527 (UMLS CUI [1,3])
C1533728 (UMLS CUI [2,1])
C3830527 (UMLS CUI [2,2])
Biopsy of liver Consistent with Chronic Hepatitis C | Compensated cirrhosis | Compensated cirrhosis Absent
Item
liver biopsy findings consistent with the diagnosis of chronic hepatitis c infection with or without compensated cirrhosis (exception: hemophiliacs in whom biopsy is medically contra-indicated do not require biopsy.)
boolean
C0193388 (UMLS CUI [1,1])
C0332290 (UMLS CUI [1,2])
C0524910 (UMLS CUI [1,3])
C1608426 (UMLS CUI [2])
C1608426 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Compensated liver disease Child-Pugh Classification
Item
compensated liver disease (child-pugh grade a clinical classification)
boolean
C3839044 (UMLS CUI [1,1])
C4050412 (UMLS CUI [1,2])
Childbearing Potential Urine pregnancy test negative | Childbearing Potential Pregnancy blood test Negative
Item
negative urine or blood pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of study drug
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])
Females & males of reproductive potential Receiving Ribavirin | Females & males of reproductive potential Contraceptive methods Quantity
Item
all fertile males and females receiving ribavirin must be using two forms of effective contraception during treatment and during the 6 months after treatment end
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)
Pregnancy | Breast Feeding
Item
women with ongoing pregnancy or breast feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Antineoplastic Therapy Systemic | Immunomodulatory therapy | Steroid therapy | Therapeutic radiology procedure
Item
therapy with any systemic anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) *6 months prior to the first dose of study drug
boolean
C2346834 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C1963758 (UMLS CUI [2])
C0149783 (UMLS CUI [3])
C1522449 (UMLS CUI [4])
Investigational New Drugs
Item
any investigational drug *6 weeks prior to the first dose of study drug
boolean
C0013230 (UMLS CUI [1])
Coinfection Hepatitis A | HBV coinfection | Human immunodeficiency virus (HIV) coinfection
Item
co-infection with active 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])
Medical condition Associated with Chronic liver disease | Exception Hepatitis C | Hemochromatosis | Hepatitis, Autoimmune | Liver disease Metabolic | Alcoholic Liver Diseases | Exposure to toxin
Item
history or other evidence of a medical condition associated with chronic liver disease other than hcv (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures)
boolean
C3843040 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0341439 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0019196 (UMLS CUI [2,2])
C0018995 (UMLS CUI [3])
C0241910 (UMLS CUI [4])
C0023895 (UMLS CUI [5,1])
C0311400 (UMLS CUI [5,2])
C0023896 (UMLS CUI [6])
C0040537 (UMLS CUI [7])
Sign or Symptom Liver carcinoma
Item
signs or symptoms of hepatocellular carcinoma
boolean
C3540840 (UMLS CUI [1,1])
C2239176 (UMLS CUI [1,2])
Bleeding esophageal varices | Condition Consistent with Decompensated liver disease
Item
history or other evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease
boolean
C0155789 (UMLS CUI [1])
C0348080 (UMLS CUI [2,1])
C0332290 (UMLS CUI [2,2])
C4075847 (UMLS CUI [2,3])
Neutrophil count | Platelet Count measurement
Item
neutrophil count <1500 cells/mm3 or platelet count <90,000 cells/mm3 at screening
boolean
C0200633 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
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