ID

27910

Descrição

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

Palavras-chave

  1. 05/12/2017 05/12/2017 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

5 de dezembro de 2017

DOI

Para um pedido faça login.

Licença

Creative Commons BY 4.0

Comentários do modelo :

Aqui pode comentar o modelo. Pode comentá-lo especificamente através dos balões de texto nos grupos de itens e itens.

Comentários do grupo de itens para :

Comentários do item para :

Para descarregar formulários, precisa de ter uma sessão iniciada. Por favor faça login ou registe-se gratuitamente.

Eligibility Chronic Hepatitis C NCT01012895

Eligibility Chronic Hepatitis C NCT01012895

Inclusion Criteria
Descrição

Inclusion Criteria

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

Age

Tipo de dados

boolean

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

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

Tipo de dados

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.
Descrição

Hepatitis C Virus genotype 1b

Tipo de dados

boolean

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

Exclusion Criteria

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

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

Tipo de dados

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
Descrição

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

Tipo de dados

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
Descrição

Malignant Neoplasms

Tipo de dados

boolean

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

Gastrointestinal Diseases | Gastrointestinal Surgical Procedure | Exception Cholecystectomy

Tipo de dados

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
Descrição

Heart Disease

Tipo de dados

boolean

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

Deficiency of glucose-6-phosphate dehydrogenase

Tipo de dados

boolean

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

Liver Cirrhosis

Tipo de dados

boolean

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

HIV Seropositivity | Hepatitis B virus test positive

Tipo de dados

boolean

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

Pregnancy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961

Similar models

Eligibility Chronic Hepatitis C NCT01012895

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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])

Use este formulário para feedback, perguntas e sugestões de aperfeiçoamento.

Campos marcados com * são obrigatórios.

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