ID

39725

Descripción

A Study of The Relationship Between Drop in Hemoglobin and Sustained Virological Response in Patients With Chronic Hepatitis C Treated With Copegus (Ribavirin) and Pegasys (Peginterferon Alfa-2a); ODM derived from: https://clinicaltrials.gov/show/NCT01585324

Link

https://clinicaltrials.gov/show/NCT01585324

Palabras clave

Versiones (1)
  1. 13/2/20 13/2/20 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

13 de febrero de 2020

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Hepatitis C, Chronic NCT01585324

Inglés

Eligibility Hepatitis C, Chronic NCT01585324

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, genotype 1
Descripción

Chronic Hepatitis C Genotype

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0524910
UMLS CUI [1,2]
C1533728
treatment-naïve or patients who relapsed or failed to respond to previous combination therapy with interferon and ribavirin
Descripción

Therapy naive | Recurrent disease | Unresponsive to Combination therapy Interferon Ribavirin

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0919936
UMLS CUI [2]
C0277556
UMLS CUI [3,1]
C0205269
UMLS CUI [3,2]
C0009429
UMLS CUI [3,3]
C3652465
UMLS CUI [3,4]
C0035525
detectable hcv-rna
Descripción

Hepatitis C virus RNA Detectable

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0369335
UMLS CUI [1,2]
C3830527
fertile males and females of child-bearing potential must agree to use two forms of contraception during treatment and for 6 months after treatment end
Descripción

Females & males of reproductive potential Contraceptive methods Quantity

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C4034483
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C1265611
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant or breast-feeding women
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
male partners of pregnant women
Descripción

Gender Partner Pregnancy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0682323
UMLS CUI [1,3]
C0032961
history or evidence of a medical condition associated with chronic liver disease other than hcv
Descripción

Medical condition Associated with Chronic liver disease | Exception Hepatitis C

Tipo de datos

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]
C0019196
co-infection with active hepatitis a, hepatitis b and/or hiv virus
Descripción

Coinfection Hepatitis A | HBV coinfection | HIV coinfection

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0275524
UMLS CUI [1,2]
C0019159
UMLS CUI [2]
C2242656
UMLS CUI [3]
C4062778
hepatocellular carcinoma
Descripción

Liver carcinoma

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2239176
history or evidence of oesophageal varices or other conditions consistent with decompensated liver disease
Descripción

Esophageal Varices | Condition Consistent with Decompensated liver disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0014867
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0332290
UMLS CUI [2,3]
C4075847
anemia
Descripción

Anemia

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0002871
any patient with increased baseline risk for anemia (e.g. thalassemia, spherocyctosis, history of gi bleeding)
Descripción

High risk of Anemia | Thalassemia | Spherocytosis | Gastrointestinal Hemorrhage

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0332167
UMLS CUI [1,2]
C0002871
UMLS CUI [2]
C0039730
UMLS CUI [3]
C0553720
UMLS CUI [4]
C0017181
history or evidence of significant cardiovascular disease
Descripción

Cardiovascular Disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0007222
kidney disease
Descripción

Kidney Disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0022658
severe retinopathy
Descripción

Retinal Disease Severe

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0035309
UMLS CUI [1,2]
C0205082
history of severe psychiatric disease, especially depression
Descripción

Mental Disorders, Severe | Severe depression

Tipo de datos

boolean

Alias
UMLS CUI [1]
C4046029
UMLS CUI [2]
C0588008
therapy with any systemic anti-viral, anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) </= 6 months prior to first dose of study drug
Descripción

Antiviral Therapy Systemic | Antineoplastic Agents Systemic | Immunomodulatory therapy Systemic | Steroid therapy High dose | Therapeutic radiology procedure

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0280274
UMLS CUI [1,2]
C0205373
UMLS CUI [2,1]
C0003392
UMLS CUI [2,2]
C0205373
UMLS CUI [3,1]
C1963758
UMLS CUI [3,2]
C0205373
UMLS CUI [4,1]
C0149783
UMLS CUI [4,2]
C0444956
UMLS CUI [5]
C1522449
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Similar models

Eligibility Hepatitis C, Chronic NCT01585324

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])
Chronic Hepatitis C Genotype
Item
chronic hepatitis c, genotype 1
boolean
C0524910 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
Therapy naive | Recurrent disease | Unresponsive to Combination therapy Interferon Ribavirin
Item
treatment-naïve or patients who relapsed or failed to respond to previous combination therapy with interferon and ribavirin
boolean
C0919936 (UMLS CUI [1])
C0277556 (UMLS CUI [2])
C0205269 (UMLS CUI [3,1])
C0009429 (UMLS CUI [3,2])
C3652465 (UMLS CUI [3,3])
C0035525 (UMLS CUI [3,4])
Hepatitis C virus RNA Detectable
Item
detectable hcv-rna
boolean
C0369335 (UMLS CUI [1,1])
C3830527 (UMLS CUI [1,2])
Females & males of reproductive potential Contraceptive methods Quantity
Item
fertile males and females of child-bearing potential must agree to use two forms of contraception during treatment and for 6 months after treatment end
boolean
C4034483 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
pregnant or breast-feeding women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Gender Partner Pregnancy
Item
male partners of pregnant women
boolean
C0079399 (UMLS CUI [1,1])
C0682323 (UMLS CUI [1,2])
C0032961 (UMLS CUI [1,3])
Medical condition Associated with Chronic liver disease | Exception Hepatitis C
Item
history or evidence of a medical condition associated 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])
C0019196 (UMLS CUI [2,2])
Coinfection Hepatitis A | HBV coinfection | HIV coinfection
Item
co-infection with active hepatitis a, hepatitis b and/or hiv virus
boolean
C0275524 (UMLS CUI [1,1])
C0019159 (UMLS CUI [1,2])
C2242656 (UMLS CUI [2])
C4062778 (UMLS CUI [3])
Liver carcinoma
Item
hepatocellular carcinoma
boolean
C2239176 (UMLS CUI [1])
Esophageal Varices | Condition Consistent with Decompensated liver disease
Item
history or evidence of oesophageal varices or other conditions consistent with decompensated liver disease
boolean
C0014867 (UMLS CUI [1])
C0348080 (UMLS CUI [2,1])
C0332290 (UMLS CUI [2,2])
C4075847 (UMLS CUI [2,3])
Anemia
Item
anemia
boolean
C0002871 (UMLS CUI [1])
High risk of Anemia | Thalassemia | Spherocytosis | Gastrointestinal Hemorrhage
Item
any patient with increased baseline risk for anemia (e.g. thalassemia, spherocyctosis, history of gi bleeding)
boolean
C0332167 (UMLS CUI [1,1])
C0002871 (UMLS CUI [1,2])
C0039730 (UMLS CUI [2])
C0553720 (UMLS CUI [3])
C0017181 (UMLS CUI [4])
Cardiovascular Disease
Item
history or evidence of significant cardiovascular disease
boolean
C0007222 (UMLS CUI [1])
Kidney Disease
Item
kidney disease
boolean
C0022658 (UMLS CUI [1])
Retinal Disease Severe
Item
severe retinopathy
boolean
C0035309 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Mental Disorders, Severe | Severe depression
Item
history of severe psychiatric disease, especially depression
boolean
C4046029 (UMLS CUI [1])
C0588008 (UMLS CUI [2])
Antiviral Therapy Systemic | Antineoplastic Agents Systemic | Immunomodulatory therapy Systemic | Steroid therapy High dose | Therapeutic radiology procedure
Item
therapy with any systemic anti-viral, anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) </= 6 months prior to first dose of study drug
boolean
C0280274 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C0003392 (UMLS CUI [2,1])
C0205373 (UMLS CUI [2,2])
C1963758 (UMLS CUI [3,1])
C0205373 (UMLS CUI [3,2])
C0149783 (UMLS CUI [4,1])
C0444956 (UMLS CUI [4,2])
C1522449 (UMLS CUI [5])
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