ID

27910

Beschrijving

Study to Determine the Effectiveness of Antiviral Combination Therapy to Treat Hepatitis C Virus (HCV) Infected Patients Who Have Previously Failed Standard of Care; ODM derived from: https://clinicaltrials.gov/show/NCT01012895

Link

https://clinicaltrials.gov/show/NCT01012895

Trefwoorden

  1. 05-12-17 05-12-17 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

5 december 2017

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.

Itemgroep Commentaren voor :

Item Commentaren voor :

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

Eligibility Chronic Hepatitis C NCT01012895

Eligibility Chronic Hepatitis C NCT01012895

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
male and female subjects ages 18 to 70 years
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
hcv-infected genotype 1 null responders to current standard of care
Beschrijving

Hepatitis C Virus genotype 1 | Standard of Care Unresponsive to Treatment

Datatype

boolean

Alias
UMLS CUI [1,1]
C0019196
UMLS CUI [1,2]
C3532919
UMLS CUI [2,1]
C2936643
UMLS CUI [2,2]
C0205269
expansion cohorts a1 and a2 are restricted to patients infected with hcv genotype 1b only.
Beschrijving

Hepatitis C Virus genotype 1b

Datatype

boolean

Alias
UMLS CUI [1,1]
C0019196
UMLS CUI [1,2]
C3495940
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
evidence of a medical condition associate with chronic liver disease other than hcv
Beschrijving

Medical condition Associated with Chronic liver disease | Exception Hepatitis C virus

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]
C0220847
history of variceal bleeding, hepatic encephalopathy, or ascites requiring management with diuretics or paracentesis
Beschrijving

Bleeding varices | Hepatic Encephalopathy | Ascites Requirement Diuretics | Ascites Requirement Paracentesis

Datatype

boolean

Alias
UMLS CUI [1]
C0333106
UMLS CUI [2]
C0019151
UMLS CUI [3,1]
C0003962
UMLS CUI [3,2]
C1514873
UMLS CUI [3,3]
C0012798
UMLS CUI [4,1]
C0003962
UMLS CUI [4,2]
C1514873
UMLS CUI [4,3]
C0034115
history of cancer within 5 years of enrollment
Beschrijving

Malignant Neoplasms

Datatype

boolean

Alias
UMLS CUI [1]
C0006826
history of gastrointestinal disease or surgical procedure (except cholecystectomy)
Beschrijving

Gastrointestinal Diseases | Gastrointestinal Surgical Procedure | Exception Cholecystectomy

Datatype

boolean

Alias
UMLS CUI [1]
C0017178
UMLS CUI [2]
C0524722
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0008320
history of clinically significant cardiac disease
Beschrijving

Heart Disease

Datatype

boolean

Alias
UMLS CUI [1]
C0018799
history of glucose-6-phosphate dehydrogenase (g6pd) deficiency
Beschrijving

Deficiency of glucose-6-phosphate dehydrogenase

Datatype

boolean

Alias
UMLS CUI [1]
C2939465
documented cirrhosis within 12 months prior to dosing
Beschrijving

Liver Cirrhosis

Datatype

boolean

Alias
UMLS CUI [1]
C0023890
positive for human immunodeficiency virus (hiv) or hepatitis b virus (hbv)
Beschrijving

HIV Seropositivity | Hepatitis B virus test positive

Datatype

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C2748184
pregnant
Beschrijving

Pregnancy

Datatype

boolean

Alias
UMLS CUI [1]
C0032961

Similar models

Eligibility Chronic Hepatitis C NCT01012895

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
male and female subjects ages 18 to 70 years
boolean
C0001779 (UMLS CUI [1])
Hepatitis C Virus genotype 1 | Standard of Care Unresponsive to Treatment
Item
hcv-infected genotype 1 null responders to current standard of care
boolean
C0019196 (UMLS CUI [1,1])
C3532919 (UMLS CUI [1,2])
C2936643 (UMLS CUI [2,1])
C0205269 (UMLS CUI [2,2])
Hepatitis C Virus genotype 1b
Item
expansion cohorts a1 and a2 are restricted to patients infected with hcv genotype 1b only.
boolean
C0019196 (UMLS CUI [1,1])
C3495940 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Medical condition Associated with Chronic liver disease | Exception Hepatitis C virus
Item
evidence of a medical condition associate with chronic liver disease other than hcv
boolean
C3843040 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0341439 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0220847 (UMLS CUI [2,2])
Bleeding varices | Hepatic Encephalopathy | Ascites Requirement Diuretics | Ascites Requirement Paracentesis
Item
history of variceal bleeding, hepatic encephalopathy, or ascites requiring management with diuretics or paracentesis
boolean
C0333106 (UMLS CUI [1])
C0019151 (UMLS CUI [2])
C0003962 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C0012798 (UMLS CUI [3,3])
C0003962 (UMLS CUI [4,1])
C1514873 (UMLS CUI [4,2])
C0034115 (UMLS CUI [4,3])
Malignant Neoplasms
Item
history of cancer within 5 years of enrollment
boolean
C0006826 (UMLS CUI [1])
Gastrointestinal Diseases | Gastrointestinal Surgical Procedure | Exception Cholecystectomy
Item
history of gastrointestinal disease or surgical procedure (except cholecystectomy)
boolean
C0017178 (UMLS CUI [1])
C0524722 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0008320 (UMLS CUI [3,2])
Heart Disease
Item
history of clinically significant cardiac disease
boolean
C0018799 (UMLS CUI [1])
Deficiency of glucose-6-phosphate dehydrogenase
Item
history of glucose-6-phosphate dehydrogenase (g6pd) deficiency
boolean
C2939465 (UMLS CUI [1])
Liver Cirrhosis
Item
documented cirrhosis within 12 months prior to dosing
boolean
C0023890 (UMLS CUI [1])
HIV Seropositivity | Hepatitis B virus test positive
Item
positive for human immunodeficiency virus (hiv) or hepatitis b virus (hbv)
boolean
C0019699 (UMLS CUI [1])
C2748184 (UMLS CUI [2])
Pregnancy
Item
pregnant
boolean
C0032961 (UMLS CUI [1])

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

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