ID

29745

Descripción

A Study Evaluating Slow Response/Non-Rapid Response in Patients With Chronic Hepatitis C, Genotype 1, 2, 3 & 4 Treated With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin); ODM derived from: https://clinicaltrials.gov/show/NCT01429792

Link

https://clinicaltrials.gov/show/NCT01429792

Palabras clave

Versiones (2)
  1. 18/4/18 18/4/18 -
  2. 20/9/21 20/9/21 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

18 de abril de 2018

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Hepatitis C, Chronic NCT01429792

Inglés

Eligibility Hepatitis C, Chronic NCT01429792

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
serologic evidence of chronic hepatitis c, genotype 1, 2, 3 or 4 by anti-hcv antibody test
Descripción

Chronic Hepatitis C HCV genotype determination | Hepatitis C antibody, confirmatory test

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0524910
UMLS CUI [1,2]
C1533728
UMLS CUI [2]
C0373853
documented pre-treatment hcv rna quantitative result
Descripción

Serum hepatitis c viral rna quantitative pre treatment

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C4272238
UMLS CUI [1,2]
C2709094
compensated liver disease (child-pugh grade a)
Descripción

Compensated liver disease Child-Pugh Classification

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3839044
UMLS CUI [1,2]
C2347612
patient receiving standard combination treatment of pegasys (peginterferon alfa-2a and copegus (ribavirin)
Descripción

Combined Modality Therapy | Pegasys | Peginterferon alfa-2a | Copegus | Ribavirin

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0009429
UMLS CUI [2]
C1176430
UMLS CUI [3]
C0391001
UMLS CUI [4]
C1170183
UMLS CUI [5]
C0035525
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
decompensated liver disease (child-pugh class b or c cirrhosis)
Descripción

Decompensated liver disease Child-Pugh Classification

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C4075847
UMLS CUI [1,2]
C2347612
co-infection with active hepatitis a and/or hepatitis b
Descripción

HAV Coinfection | HBV coinfection

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0376325
UMLS CUI [1,2]
C0275524
UMLS CUI [2]
C2242656
history or evidence of a medical condition associated with liver disease other than hcv
Descripción

Medical condition Associated with Liver disease | Exception Hepatitis C

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C0023895
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0019196
signs and symptoms of hepatocellular carcinoma
Descripción

Signs and Symptoms Liver carcinoma

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0037088
UMLS CUI [1,2]
C2239176
history of poorly controlled thyroid disease, elevated tsh or any clinical manifestations of thyroid disease
Descripción

Thyroid Disease Poorly controlled | Elevated TSH | Manifestation Clinical Thyroid Disease

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0040128
UMLS CUI [1,2]
C3853134
UMLS CUI [2]
C1855743
UMLS CUI [3,1]
C0205319
UMLS CUI [3,2]
C0205210
UMLS CUI [3,3]
C0040128
therapy with antineoplastic treatment </= 6 months prior to study day
Descripción

Antineoplastic Drug/Agent Therapy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2346834
diabetes mellitus in subjects receiving an insulin therapy
Descripción

Insulin regime Diabetes Mellitus

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0557978
UMLS CUI [1,2]
C0011849
evidence of severe retinopathy
Descripción

Retinal Diseases Severe

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0035309
UMLS CUI [1,2]
C0205082
pregnant or breast-feeding women, and male partners of women who 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 NCT01429792

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 HCV genotype determination | Hepatitis C antibody, confirmatory test
Item
serologic evidence of chronic hepatitis c, genotype 1, 2, 3 or 4 by anti-hcv antibody test
boolean
C0524910 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
C0373853 (UMLS CUI [2])
Serum hepatitis c viral rna quantitative pre treatment
Item
documented pre-treatment hcv rna quantitative result
boolean
C4272238 (UMLS CUI [1,1])
C2709094 (UMLS CUI [1,2])
Compensated liver disease Child-Pugh Classification
Item
compensated liver disease (child-pugh grade a)
boolean
C3839044 (UMLS CUI [1,1])
C2347612 (UMLS CUI [1,2])
Combined Modality Therapy | Pegasys | Peginterferon alfa-2a | Copegus | Ribavirin
Item
patient receiving standard combination treatment of pegasys (peginterferon alfa-2a and copegus (ribavirin)
boolean
C0009429 (UMLS CUI [1])
C1176430 (UMLS CUI [2])
C0391001 (UMLS CUI [3])
C1170183 (UMLS CUI [4])
C0035525 (UMLS CUI [5])
Item Group
C0680251 (UMLS CUI)
Decompensated liver disease Child-Pugh Classification
Item
decompensated liver disease (child-pugh class b or c cirrhosis)
boolean
C4075847 (UMLS CUI [1,1])
C2347612 (UMLS CUI [1,2])
HAV Coinfection | HBV coinfection
Item
co-infection with active hepatitis a and/or hepatitis b
boolean
C0376325 (UMLS CUI [1,1])
C0275524 (UMLS CUI [1,2])
C2242656 (UMLS CUI [2])
Medical condition Associated with Liver disease | Exception Hepatitis C
Item
history or evidence of a medical condition associated with liver disease other than hcv
boolean
C3843040 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0023895 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0019196 (UMLS CUI [2,2])
Signs and Symptoms Liver carcinoma
Item
signs and symptoms of hepatocellular carcinoma
boolean
C0037088 (UMLS CUI [1,1])
C2239176 (UMLS CUI [1,2])
Thyroid Disease Poorly controlled | Elevated TSH | Manifestation Clinical Thyroid Disease
Item
history of poorly controlled thyroid disease, elevated tsh or any clinical manifestations of thyroid disease
boolean
C0040128 (UMLS CUI [1,1])
C3853134 (UMLS CUI [1,2])
C1855743 (UMLS CUI [2])
C0205319 (UMLS CUI [3,1])
C0205210 (UMLS CUI [3,2])
C0040128 (UMLS CUI [3,3])
Antineoplastic Drug/Agent Therapy
Item
therapy with antineoplastic treatment </= 6 months prior to study day
boolean
C2346834 (UMLS CUI [1])
Insulin regime Diabetes Mellitus
Item
diabetes mellitus in subjects receiving an insulin therapy
boolean
C0557978 (UMLS CUI [1,1])
C0011849 (UMLS CUI [1,2])
Retinal Diseases Severe
Item
evidence of severe retinopathy
boolean
C0035309 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Pregnancy | Breast Feeding | Gender Partner Pregnancy
Item
pregnant or breast-feeding women, and male partners of women who 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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