ID

40998

Description

VX-950-C211 - A Dosing Regimen Study (Twice Daily Versus Every 8 Hours) of Telaprevir in Treatment-naïve Participants With Genotype 1 Chronic Hepatitis C Virus Infection; ODM derived from: https://clinicaltrials.gov/show/NCT01241760

Lien

https://clinicaltrials.gov/show/NCT01241760

Mots-clés

Versions (1)
  1. 09/06/2020 09/06/2020 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

9 juin 2020

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Genotype 1 Chronic Hepatitis C NCT01241760

Anglais

Eligibility Genotype 1 Chronic Hepatitis C NCT01241760

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient has chronic hcv infection genotype 1 with hcv rna level > 1,000 iu/ml
Description

Chronic Hepatitis C Genotype | Hepatitis C virus RNA assay

Type de données

boolean

Alias
UMLS CUI [1,1]
C0524910
UMLS CUI [1,2]
C1533728
UMLS CUI [2]
C1272251
patients should not have had any previous treatment for hepatitis c
Description

Hepatitis C Untreated

Type de données

boolean

Alias
UMLS CUI [1,1]
C0019196
UMLS CUI [1,2]
C0332155
patient must have documentation of a liver biopsy within 2 years before the screening visit or the patient must agree to have a biopsy performed within the screening period
Description

Biopsy of liver

Type de données

boolean

Alias
UMLS CUI [1]
C0193388
patients with cirrhosis should have serum alpha-fetoprotein (afp) <= 50 ng/ml. if afp > 50 ng/ml, absence of a mass must be demonstrated by ultrasound within the screening period
Description

Liver Cirrhosis | Serum alpha-fetoprotein (AFP) measurement | Tumor Mass Absent Ultrasonography

Type de données

boolean

Alias
UMLS CUI [1]
C0023890
UMLS CUI [2]
C0546833
UMLS CUI [3,1]
C3273930
UMLS CUI [3,2]
C0332197
UMLS CUI [3,3]
C0041618
a female patient of childbearing potential and a nonvasectomized male patient who has a female partner of childbearing potential must agree to the use of 2 effective methods of birth control from screening until 6 months (female patient) or 7 months (male patient) after the last dose of rbv.
Description

Childbearing Potential Contraceptive methods Quantity | Gender Partner Childbearing Potential Contraceptive methods

Type de données

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0682323
UMLS CUI [2,3]
C3831118
UMLS CUI [2,4]
C0700589
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient is infected or co-infected with hcv of another genotype than genotype 1 and/or patient is infected with more than one genotype subtype
Description

Hepatitis C Genotype | HCV coinfection Genotype | Hepatitis C Genotype Quantity

Type de données

boolean

Alias
UMLS CUI [1,1]
C0019196
UMLS CUI [1,2]
C1533728
UMLS CUI [2,1]
C1698259
UMLS CUI [2,2]
C1533728
UMLS CUI [3,1]
C0019196
UMLS CUI [3,2]
C1148363
UMLS CUI [3,3]
C1265611
patient has a pre-existing psychiatric condition
Description

Mental disorder Pre-existing

Type de données

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C2347662
patient has history of decompensated liver disease or shows evidence of significant liver disease in addition to hepatitis c
Description

Decompensated liver disease | Liver disease In addition to Hepatitis C

Type de données

boolean

Alias
UMLS CUI [1]
C4075847
UMLS CUI [2,1]
C0023895
UMLS CUI [2,2]
C0332287
UMLS CUI [2,3]
C0019196
patient has human immunodeficiency virus (hiv) or hepatitis b virus (hbv) co-infection
Description

HIV coinfection | HBV coinfection

Type de données

boolean

Alias
UMLS CUI [1]
C4062778
UMLS CUI [2]
C2242656
patient has active malignant disease or history of malignant disease within the past 5 years (with the exception of treated basal cell carcinoma).
Description

Malignant disease | Exception Basal cell carcinoma Treated

Type de données

boolean

Alias
UMLS CUI [1]
C0442867
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [2,3]
C1522326
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Similar models

Eligibility Genotype 1 Chronic Hepatitis C NCT01241760

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Chronic Hepatitis C Genotype | Hepatitis C virus RNA assay
Item
patient has chronic hcv infection genotype 1 with hcv rna level > 1,000 iu/ml
boolean
C0524910 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
C1272251 (UMLS CUI [2])
Hepatitis C Untreated
Item
patients should not have had any previous treatment for hepatitis c
boolean
C0019196 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
Biopsy of liver
Item
patient must have documentation of a liver biopsy within 2 years before the screening visit or the patient must agree to have a biopsy performed within the screening period
boolean
C0193388 (UMLS CUI [1])
Liver Cirrhosis | Serum alpha-fetoprotein (AFP) measurement | Tumor Mass Absent Ultrasonography
Item
patients with cirrhosis should have serum alpha-fetoprotein (afp) <= 50 ng/ml. if afp > 50 ng/ml, absence of a mass must be demonstrated by ultrasound within the screening period
boolean
C0023890 (UMLS CUI [1])
C0546833 (UMLS CUI [2])
C3273930 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0041618 (UMLS CUI [3,3])
Childbearing Potential Contraceptive methods Quantity | Gender Partner Childbearing Potential Contraceptive methods
Item
a female patient of childbearing potential and a nonvasectomized male patient who has a female partner of childbearing potential must agree to the use of 2 effective methods of birth control from screening until 6 months (female patient) or 7 months (male patient) after the last dose of rbv.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0079399 (UMLS CUI [2,1])
C0682323 (UMLS CUI [2,2])
C3831118 (UMLS CUI [2,3])
C0700589 (UMLS CUI [2,4])
Item Group
C0680251 (UMLS CUI)
Hepatitis C Genotype | HCV coinfection Genotype | Hepatitis C Genotype Quantity
Item
patient is infected or co-infected with hcv of another genotype than genotype 1 and/or patient is infected with more than one genotype subtype
boolean
C0019196 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
C1698259 (UMLS CUI [2,1])
C1533728 (UMLS CUI [2,2])
C0019196 (UMLS CUI [3,1])
C1148363 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
Mental disorder Pre-existing
Item
patient has a pre-existing psychiatric condition
boolean
C0004936 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
Decompensated liver disease | Liver disease In addition to Hepatitis C
Item
patient has history of decompensated liver disease or shows evidence of significant liver disease in addition to hepatitis c
boolean
C4075847 (UMLS CUI [1])
C0023895 (UMLS CUI [2,1])
C0332287 (UMLS CUI [2,2])
C0019196 (UMLS CUI [2,3])
HIV coinfection | HBV coinfection
Item
patient has human immunodeficiency virus (hiv) or hepatitis b virus (hbv) co-infection
boolean
C4062778 (UMLS CUI [1])
C2242656 (UMLS CUI [2])
Malignant disease | Exception Basal cell carcinoma Treated
Item
patient has active malignant disease or history of malignant disease within the past 5 years (with the exception of treated basal cell carcinoma).
boolean
C0442867 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
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