ID

44427

Descripción

A Study of the Safety of Individualized Combination Therapy With Copegus (Ribavirin) and Pegasys (Peginterferon Alfa-2a) in Patients With Chronic Hepatitis C (MASTER); ODM derived from: https://clinicaltrials.gov/show/NCT01296971

Link

https://clinicaltrials.gov/show/NCT01296971

Palabras clave

Versiones (2)
  1. 11/2/20 11/2/20 -
  2. 20/9/21 20/9/21 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

20 de septiembre de 2021

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Hepatitis C, Chronic NCT01296971

Inglés

Eligibility Hepatitis C, Chronic NCT01296971

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult patients, >/= 18 years of age
Descripción

Adult | Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
chronic hepatitis c
Descripción

Hepatitis C, Chronic

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0524910
measurable serum hvc rna levels
Descripción

Hepatitis C virus RNA assay Serum

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1272251
UMLS CUI [1,2]
C0229671
compensated liver disease (child-pugh class a)
Descripción

Compensated liver disease Child-Pugh Classification

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3839044
UMLS CUI [1,2]
C4050412
treatment-naive for standard or pegylated interferons, or non-responder or relapsing
Descripción

Standard therapy Absent | PEGINTERFERON | Therapy non-responder | Recurrent disease

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2936643
UMLS CUI [1,2]
C0332197
UMLS CUI [2]
C0982327
UMLS CUI [3]
C0919875
UMLS CUI [4]
C0277556
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
concomitant hepatitis a or b
Descripción

Hepatitis A | Hepatitis B

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019159
UMLS CUI [2]
C0019163
history of chronic liver disease not caused by hepatitis c virus
Descripción

Chronic liver disease | Etiology Except Hepatitis C virus

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0341439
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0332300
UMLS CUI [2,3]
C0220847
hepatocellular carcinoma
Descripción

Liver carcinoma

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2239176
history or signs of esophageal varices haemorrhage or other conditions indicative of decompensated liver disease
Descripción

Bleeding esophageal varices | Signs Bleeding esophageal varices | Condition Indication of Decompensated liver disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0155789
UMLS CUI [2,1]
C0311392
UMLS CUI [2,2]
C0155789
UMLS CUI [3,1]
C0348080
UMLS CUI [3,2]
C0392360
UMLS CUI [3,3]
C4075847
treatment with any systemic anti-tumor or immunomodulatory agent (including steroids at doses exceeding physiological ones, and radiotherapy) within 6 months prior to first dose of study drug
Descripción

Antineoplastic Agents Systemic | Immunomodulatory agents Systemic | Steroid therapy | Therapeutic radiology procedure

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0003392
UMLS CUI [1,2]
C0205373
UMLS CUI [2,1]
C0005525
UMLS CUI [2,2]
C0205373
UMLS CUI [3]
C0149783
UMLS CUI [4]
C1522449
pregnant or lactating women, or men whose partners are pregnant
Descripción

Pregnancy | Breast Feeding | Gender Partner Pregnancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0682323
UMLS CUI [3,3]
C0032961
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Similar models

Eligibility Hepatitis C, Chronic NCT01296971

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Age
Item
adult patients, >/= 18 years of age
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Hepatitis C, Chronic
Item
chronic hepatitis c
boolean
C0524910 (UMLS CUI [1])
Hepatitis C virus RNA assay Serum
Item
measurable serum hvc rna levels
boolean
C1272251 (UMLS CUI [1,1])
C0229671 (UMLS CUI [1,2])
Compensated liver disease Child-Pugh Classification
Item
compensated liver disease (child-pugh class a)
boolean
C3839044 (UMLS CUI [1,1])
C4050412 (UMLS CUI [1,2])
Standard therapy Absent | PEGINTERFERON | Therapy non-responder | Recurrent disease
Item
treatment-naive for standard or pegylated interferons, or non-responder or relapsing
boolean
C2936643 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0982327 (UMLS CUI [2])
C0919875 (UMLS CUI [3])
C0277556 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
Hepatitis A | Hepatitis B
Item
concomitant hepatitis a or b
boolean
C0019159 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
Chronic liver disease | Etiology Except Hepatitis C virus
Item
history of chronic liver disease not caused by hepatitis c virus
boolean
C0341439 (UMLS CUI [1])
C0015127 (UMLS CUI [2,1])
C0332300 (UMLS CUI [2,2])
C0220847 (UMLS CUI [2,3])
Liver carcinoma
Item
hepatocellular carcinoma
boolean
C2239176 (UMLS CUI [1])
Bleeding esophageal varices | Signs Bleeding esophageal varices | Condition Indication of Decompensated liver disease
Item
history or signs of esophageal varices haemorrhage or other conditions indicative of decompensated liver disease
boolean
C0155789 (UMLS CUI [1])
C0311392 (UMLS CUI [2,1])
C0155789 (UMLS CUI [2,2])
C0348080 (UMLS CUI [3,1])
C0392360 (UMLS CUI [3,2])
C4075847 (UMLS CUI [3,3])
Antineoplastic Agents Systemic | Immunomodulatory agents Systemic | Steroid therapy | Therapeutic radiology procedure
Item
treatment with any systemic anti-tumor or immunomodulatory agent (including steroids at doses exceeding physiological ones, and radiotherapy) within 6 months prior to first dose of study drug
boolean
C0003392 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C0005525 (UMLS CUI [2,1])
C0205373 (UMLS CUI [2,2])
C0149783 (UMLS CUI [3])
C1522449 (UMLS CUI [4])
Pregnancy | Breast Feeding | Gender Partner Pregnancy
Item
pregnant or lactating women, or men whose partners are pregnant
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0079399 (UMLS CUI [3,1])
C0682323 (UMLS CUI [3,2])
C0032961 (UMLS CUI [3,3])
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