ID

40998

Beschreibung

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

Link

https://clinicaltrials.gov/show/NCT01241760

Stichworte

Versionen (1)
  1. 09.06.20 09.06.20 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

9. Juni 2020

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY 4.0
Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

Eligibility Genotype 1 Chronic Hepatitis C NCT01241760

Englisch

Eligibility Genotype 1 Chronic Hepatitis C NCT01241760

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

Chronic Hepatitis C Genotype | Hepatitis C virus RNA assay

Datentyp

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
Beschreibung

Hepatitis C Untreated

Datentyp

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
Beschreibung

Biopsy of liver

Datentyp

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
Beschreibung

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

Datentyp

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.
Beschreibung

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

Datentyp

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
Beschreibung

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
Beschreibung

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

Datentyp

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
Beschreibung

Mental disorder Pre-existing

Datentyp

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
Beschreibung

Decompensated liver disease | Liver disease In addition to Hepatitis C

Datentyp

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
Beschreibung

HIV coinfection | HBV coinfection

Datentyp

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).
Beschreibung

Malignant disease | Exception Basal cell carcinoma Treated

Datentyp

boolean

Alias
UMLS CUI [1]
C0442867
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [2,3]
C1522326
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Eligibility Genotype 1 Chronic Hepatitis C NCT01241760

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
Zum Seitenanfang zurückkehren 

Kontakt

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Hilfe

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video