ID

44413

Beschrijving

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

Trefwoorden

Versies (2)
  1. 09-02-20 09-02-20 -
  2. 20-09-21 20-09-21 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

20 september 2021

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility Hepatitis C NCT01937728

Engels

Eligibility Hepatitis C NCT01937728

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

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

Age

Datatype

boolean

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

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

Datatype

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
Beschrijving

Serology positive Chronic Hepatitis C | Hepatitis C antibody test

Datatype

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
Beschrijving

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

Datatype

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.)
Beschrijving

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

Datatype

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)
Beschrijving

Compensated liver disease Child-Pugh Classification

Datatype

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
Beschrijving

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

Datatype

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
Beschrijving

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

Datatype

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
Beschrijving

Exclusion Criteria

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

Pregnancy | Breast Feeding

Datatype

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
Beschrijving

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

Datatype

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
Beschrijving

Investigational New Drugs

Datatype

boolean

Alias
UMLS CUI [1]
C0013230
co-infection with active hepatitis a, hepatitis b and/or human immunodeficiency virus (hiv)
Beschrijving

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

Datatype

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)
Beschrijving

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

Datatype

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
Beschrijving

Sign or Symptom Liver carcinoma

Datatype

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
Beschrijving

Bleeding esophageal varices | Condition Consistent with Decompensated liver disease

Datatype

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
Beschrijving

Neutrophil count | Platelet Count measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0200633
UMLS CUI [2]
C0032181
Terug naar het begin van de pagina

Similar models

Eligibility Hepatitis C NCT01937728

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

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