ID

39726

Descripción

A Triple Combination Therapy Study of Boceprevir, Pegasys and Copegus in Previously Untreated Patients With Genotype 1 Chronic Hepatitis C; ODM derived from: https://clinicaltrials.gov/show/NCT01591460

Link

https://clinicaltrials.gov/show/NCT01591460

Palabras clave

Versiones (2)
  1. 13/2/20 13/2/20 -
  2. 20/9/21 20/9/21 -
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 NCT01591460

Inglés

Eligibility Hepatitis C, Chronic NCT01591460

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 liver disease consistent with chronic hepatitis c, genotype 1 infection
Descripción

Chronic liver disease Consistent with Chronic Hepatitis C Genotype

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0341439
UMLS CUI [1,2]
C0332290
UMLS CUI [1,3]
C0524910
UMLS CUI [1,4]
C1533728
serum hcv rna quantifiable at screening
Descripción

Serum hepatitis c viral rna quantitative

Tipo de datos

boolean

Alias
UMLS CUI [1]
C4272238
patients who have not been previously treated with pegylated interferon (ifn), standard ifn, rbv or any direct acting anti-viral agent
Descripción

PEGINTERFERON Absent | Interferon Absent | Ribavirin Absent | DIRECT ACTING ANTIVIRALS Absent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0982327
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C3652465
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0035525
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C3653501
UMLS CUI [4,2]
C0332197
compensated liver disease (child-pugh grade a clinical classification for patients with cirrhosis: total score </=6)
Descripción

Compensated liver disease Child-Pugh Classification | Patients Liver Cirrhosis | Compensated liver disease Child-Pugh - Total Score

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3839044
UMLS CUI [1,2]
C2347612
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C0023890
UMLS CUI [3,1]
C3839044
UMLS CUI [3,2]
C4055253
negative urine or blood pregnancy test (for women of childbearing potential)
Descripción

Childbearing Potential Urine pregnancy test negative | Childbearing Potential Pregnancy blood test Negative

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430057
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0850355
UMLS CUI [2,3]
C1513916
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
women with ongoing pregnancy or breast feeding
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

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

Gender Partner Pregnancy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0682323
UMLS CUI [1,3]
C0032961
therapy with any systemic anti-viral, anti-neoplastic or immunomodulatory treatment </=6 months prior to the first dose of study drug
Descripción

Antiviral Therapy Systemic | Antineoplastic Agents Systemic | Immunomodulatory therapy Systemic

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
any investigational drug </=6 weeks prior to the first dose of study drug
Descripción

Investigational New Drugs

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0013230
history or other evidence of decompensated liver disease
Descripción

Decompensated liver disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C4075847
history or other evidence of a medical condition associated with chronic liver disease other than chronic hepatitis c
Descripción

Medical condition Associated with Chronic liver disease | Exception Chronic 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]
C0524910
signs or symptoms of hepatocellular carcinoma
Descripción

Sign or Symptom Liver carcinoma

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3540840
UMLS CUI [1,2]
C2239176
co-infection with hcv genotypes other than genotype 1
Descripción

HCV coinfection Genotype | Exception Hepatitis C virus genotype determination

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1698259
UMLS CUI [1,2]
C1148363
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1533728
co-infection with hepatitis a, hepatitis b, and/or human immunodeficiency virus (hiv)
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
any patient with an increased risk for anemia
Descripción

High risk of Anemia

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0332167
UMLS CUI [1,2]
C0002871
history of severe psychiatric disease
Descripción

Mental Disorders, Severe

Tipo de datos

boolean

Alias
UMLS CUI [1]
C4046029
history of immunologically mediated, chronic pulmonary, or severe cardiac disease
Descripción

Disease Immune-mediated | Chronic lung disease | Heart Disease Severe

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C4330477
UMLS CUI [2]
C0746102
UMLS CUI [3,1]
C0018799
UMLS CUI [3,2]
C0205082
current diseases that are not adequately controlled
Descripción

Disease Poorly controlled

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C3853134
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Similar models

Eligibility Hepatitis C, Chronic NCT01591460

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 liver disease Consistent with Chronic Hepatitis C Genotype
Item
chronic liver disease consistent with chronic hepatitis c, genotype 1 infection
boolean
C0341439 (UMLS CUI [1,1])
C0332290 (UMLS CUI [1,2])
C0524910 (UMLS CUI [1,3])
C1533728 (UMLS CUI [1,4])
Serum hepatitis c viral rna quantitative
Item
serum hcv rna quantifiable at screening
boolean
C4272238 (UMLS CUI [1])
PEGINTERFERON Absent | Interferon Absent | Ribavirin Absent | DIRECT ACTING ANTIVIRALS Absent
Item
patients who have not been previously treated with pegylated interferon (ifn), standard ifn, rbv or any direct acting anti-viral agent
boolean
C0982327 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C3652465 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0035525 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C3653501 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Compensated liver disease Child-Pugh Classification | Patients Liver Cirrhosis | Compensated liver disease Child-Pugh - Total Score
Item
compensated liver disease (child-pugh grade a clinical classification for patients with cirrhosis: total score </=6)
boolean
C3839044 (UMLS CUI [1,1])
C2347612 (UMLS CUI [1,2])
C0030705 (UMLS CUI [2,1])
C0023890 (UMLS CUI [2,2])
C3839044 (UMLS CUI [3,1])
C4055253 (UMLS CUI [3,2])
Childbearing Potential Urine pregnancy test negative | Childbearing Potential Pregnancy blood test Negative
Item
negative urine or blood pregnancy test (for women of childbearing potential)
boolean
C3831118 (UMLS CUI [1,1])
C0430057 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0850355 (UMLS CUI [2,2])
C1513916 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
women with ongoing pregnancy or breast feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Gender Partner Pregnancy
Item
male partners of women who are pregnant
boolean
C0079399 (UMLS CUI [1,1])
C0682323 (UMLS CUI [1,2])
C0032961 (UMLS CUI [1,3])
Antiviral Therapy Systemic | Antineoplastic Agents Systemic | Immunomodulatory therapy Systemic
Item
therapy with any systemic anti-viral, anti-neoplastic or immunomodulatory treatment </=6 months prior to the 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])
Investigational New Drugs
Item
any investigational drug </=6 weeks prior to the first dose of study drug
boolean
C0013230 (UMLS CUI [1])
Decompensated liver disease
Item
history or other evidence of decompensated liver disease
boolean
C4075847 (UMLS CUI [1])
Medical condition Associated with Chronic liver disease | Exception Chronic Hepatitis C
Item
history or other evidence of a medical condition associated with chronic liver disease other than chronic hepatitis c
boolean
C3843040 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0341439 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0524910 (UMLS CUI [2,2])
Sign or Symptom Liver carcinoma
Item
signs or symptoms of hepatocellular carcinoma
boolean
C3540840 (UMLS CUI [1,1])
C2239176 (UMLS CUI [1,2])
HCV coinfection Genotype | Exception Hepatitis C virus genotype determination
Item
co-infection with hcv genotypes other than genotype 1
boolean
C1698259 (UMLS CUI [1,1])
C1148363 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C1533728 (UMLS CUI [2,2])
Coinfection Hepatitis A | HBV coinfection | HIV coinfection
Item
co-infection with hepatitis a, hepatitis b, and/or human immunodeficiency virus (hiv)
boolean
C0275524 (UMLS CUI [1,1])
C0019159 (UMLS CUI [1,2])
C2242656 (UMLS CUI [2])
C4062778 (UMLS CUI [3])
High risk of Anemia
Item
any patient with an increased risk for anemia
boolean
C0332167 (UMLS CUI [1,1])
C0002871 (UMLS CUI [1,2])
Mental Disorders, Severe
Item
history of severe psychiatric disease
boolean
C4046029 (UMLS CUI [1])
Disease Immune-mediated | Chronic lung disease | Heart Disease Severe
Item
history of immunologically mediated, chronic pulmonary, or severe cardiac disease
boolean
C0012634 (UMLS CUI [1,1])
C4330477 (UMLS CUI [1,2])
C0746102 (UMLS CUI [2])
C0018799 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
Disease Poorly controlled
Item
current diseases that are not adequately controlled
boolean
C0012634 (UMLS CUI [1,1])
C3853134 (UMLS CUI [1,2])
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