ID

36062

Descrição

Real World Study: Genotype 1 Chronic HCV Treatment and Evaluation of Real World SVR and PROs; ODM derived from: https://clinicaltrials.gov/show/NCT02461745

Link

https://clinicaltrials.gov/show/NCT02461745

Palavras-chave

Versões (1)
  1. 12/04/2019 12/04/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

12 de abril de 2019

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Hepatitis C, Chronic NCT02461745

Inglês

Eligibility Hepatitis C, Chronic NCT02461745

1 Formulários  
Criteria
Descrição

Criteria

male or female at least 18 years of age at time of screening.
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
subject, if female must not use estrogen-containing hormonal contraception including oral, injectable, implantable, patch and ring varieties during study drug treatment
Descrição

Gender | Estrogen Contraceptive Agents Absent | Injectable contraception Absent | Contraceptive implant Absent | Contraceptive patch Absent | Other Coding

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0009907
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C1262153
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C1657106
UMLS CUI [4,2]
C0332197
UMLS CUI [5,1]
C2985284
UMLS CUI [5,2]
C0332197
UMLS CUI [6]
C3846158
subject, if male, who is not surgically sterile and is sexually active with female partner of childbearing potential must agree to practice 2 effective contraceptive methods for study duration
Descrição

Gender Male sterilization Absent | Gender Sexually active Contraceptive methods Quantity | Gender Partner Childbearing Potential Contraceptive methods

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0024559
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0241028
UMLS CUI [2,3]
C0700589
UMLS CUI [2,4]
C1265611
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0682323
UMLS CUI [3,3]
C3831118
UMLS CUI [3,4]
C0700589
subject must have at least one of the following indicators of chronic hepatitis c virus infection prior to study enrollment: positive anti-hcv antibody or hcv rna > 10,000 iu/ml at least 6 months before screening, and positive for hcv rna at the time of screening, or hcv rna > 10,000 iu/ml at screening and liver biopsy consistent with chronic hcv infection
Descrição

Indicators Quantity Chronic Hepatitis C | Hepatitis C Antibodies Positive | Hepatitis C virus RNA assay | Hepatitis C RNA positive | Biopsy of liver Consistent with Chronic Hepatitis C

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0021212
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0524910
UMLS CUI [2,1]
C0166049
UMLS CUI [2,2]
C1514241
UMLS CUI [3]
C1272251
UMLS CUI [4]
C0855842
UMLS CUI [5,1]
C0193388
UMLS CUI [5,2]
C0332290
UMLS CUI [5,3]
C0524910
subject has a screening laboratory result indicating hcv genotype 1-infection
Descrição

Laboratory Results Indication of Hepatitis C genotype

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C0019196
UMLS CUI [1,4]
C1148363
key exclusion criteria
Descrição

Exclusion Criteria Main

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1542147
subject, if female is pregnant or is breastfeeding
Descrição

Pregnancy | Breast Feeding

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
subject has positive test result for hepatitis b surface antigen or confirmed positive anti-hiv antibody test
Descrição

Hepatitis B surface antigen positive | HIV antibody positive

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0149709
UMLS CUI [2]
C0920548
subject received study contraindicated medications prior to study drug administration
Descrição

Contraindicated drug Study Protocol

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3845816
UMLS CUI [1,2]
C2348563
use of known strong inducers of cytochrome p450 3a (cyp3a) or strong inducers of cytochrome p450 2c8 (cyp2c8) or strong inhibitors of cyp2c8 within 2 weeks of the respective medication/supplement prior to initial dose of study drug.
Descrição

CYP3A Inducers | CYP2C8 Inducers | CYP2C8 Inhibitors

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3850044
UMLS CUI [2]
C3850048
UMLS CUI [3]
C3850061
clinically significant abnormalities or co-morbidities, other than hcv infection that in opinion of the investigator makes subject unsuitable for this study or drug regimen
Descrição

Abnormality Study Subject Participation Status Inappropriate | Comorbidity Study Subject Participation Status Inappropriate

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1548788
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C2348568
UMLS CUI [2,3]
C1548788
current enrollment in another interventional clinical study or prior or current use of any investigational or commercially available anti-hcv agents other than interferon or ribavirin including previous exposure to abt450 (paritaprevir) , abt-267 (ombitasvir) or abt-333 (dasabuvir) or receipt of any investigational product within 6 weeks prior to study drug administration
Descrição

Study Subject Participation Status | Interventional Study | Investigational New Drugs Against Hepatitis C | Exception Interferon | Exception Ribavirin | Exposure to ABT-450 | Exposure to Paritaprevir | Exposure to ABT-267 | Exposure to Ombitasvir | Exposure to ABT-333 | Exposure to Dasabuvir

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C3274035
UMLS CUI [3,1]
C0013230
UMLS CUI [3,2]
C0521124
UMLS CUI [3,3]
C0019196
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C3652465
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0035525
UMLS CUI [6,1]
C0332157
UMLS CUI [6,2]
C3712108
UMLS CUI [7,1]
C0332157
UMLS CUI [7,2]
C3864824
UMLS CUI [8,1]
C0332157
UMLS CUI [8,2]
C3713322
UMLS CUI [9,1]
C0332157
UMLS CUI [9,2]
C3852670
UMLS CUI [10,1]
C0332157
UMLS CUI [10,2]
C3850285
UMLS CUI [11,1]
C0332157
UMLS CUI [11,2]
C3852512
prior treatment of chronic hcv infection with a direct acting antiviral agent(s): telaprevir, boceprevir, sofosbuvir, simeprevir, or other direct acting antiviral
Descrição

Prior Therapy Chronic Hepatitis C | DIRECT ACTING ANTIVIRALS | telaprevir | boceprevir | sofosbuvir | simeprevir

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0524910
UMLS CUI [2]
C3653501
UMLS CUI [3]
C1876229
UMLS CUI [4]
C1738934
UMLS CUI [5]
C2976303
UMLS CUI [6]
C2605855
history of solid organ transplant
Descrição

Solid organ transplant

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0730400
evidence of cirrhosis
Descrição

Liver Cirrhosis

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023890
history of liver decompensation: ascites noted on a physical exam, imaging or other test; variceal bleeding; hepatic encephalopathy
Descrição

Hepatic decompensation | Ascites Physical Examination | Ascites Imaging | Ascites Test | Bleeding varices | Hepatic Encephalopathy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1394798
UMLS CUI [2,1]
C0003962
UMLS CUI [2,2]
C0031809
UMLS CUI [3,1]
C0003962
UMLS CUI [3,2]
C0011923
UMLS CUI [4,1]
C0003962
UMLS CUI [4,2]
C0456984
UMLS CUI [5]
C0333106
UMLS CUI [6]
C0019151
confirmed presence of hepatocellular carcinoma indicated on computed tomography, magnetic resonance, or other imaging techniques within 3 months prior to screening
Descrição

Liver carcinoma Computed Tomography | Liver carcinoma Magnetic Resonance Imaging | Liver carcinoma Imaging Technique

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2239176
UMLS CUI [1,2]
C0040405
UMLS CUI [2,1]
C2239176
UMLS CUI [2,2]
C0024485
UMLS CUI [3,1]
C2239176
UMLS CUI [3,2]
C0079595
hcv genotype performed during screening indicates infection with any genotype other than genotype 1
Descrição

Hepatitis C virus genotype determination | Hepatitis C Genotype | Exception Genotype Specified

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1533728
UMLS CUI [2,1]
C0019196
UMLS CUI [2,2]
C1148363
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1148363
UMLS CUI [3,3]
C0205369
recent history of drug or alcohol abuse that could, in the opinion of the investigator, affect adherence to the study protocol
Descrição

Substance Use Disorders Affecting Protocol Compliance

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0038586
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0525058
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Similar models

Eligibility Hepatitis C, Chronic NCT02461745

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Age
Item
male or female at least 18 years of age at time of screening.
boolean
C0001779 (UMLS CUI [1])
Gender | Estrogen Contraceptive Agents Absent | Injectable contraception Absent | Contraceptive implant Absent | Contraceptive patch Absent | Other Coding
Item
subject, if female must not use estrogen-containing hormonal contraception including oral, injectable, implantable, patch and ring varieties during study drug treatment
boolean
C0079399 (UMLS CUI [1])
C0009907 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C1262153 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C1657106 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C2985284 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C3846158 (UMLS CUI [6])
Gender Male sterilization Absent | Gender Sexually active Contraceptive methods Quantity | Gender Partner Childbearing Potential Contraceptive methods
Item
subject, if male, who is not surgically sterile and is sexually active with female partner of childbearing potential must agree to practice 2 effective contraceptive methods for study duration
boolean
C0079399 (UMLS CUI [1,1])
C0024559 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0079399 (UMLS CUI [2,1])
C0241028 (UMLS CUI [2,2])
C0700589 (UMLS CUI [2,3])
C1265611 (UMLS CUI [2,4])
C0079399 (UMLS CUI [3,1])
C0682323 (UMLS CUI [3,2])
C3831118 (UMLS CUI [3,3])
C0700589 (UMLS CUI [3,4])
Indicators Quantity Chronic Hepatitis C | Hepatitis C Antibodies Positive | Hepatitis C virus RNA assay | Hepatitis C RNA positive | Biopsy of liver Consistent with Chronic Hepatitis C
Item
subject must have at least one of the following indicators of chronic hepatitis c virus infection prior to study enrollment: positive anti-hcv antibody or hcv rna > 10,000 iu/ml at least 6 months before screening, and positive for hcv rna at the time of screening, or hcv rna > 10,000 iu/ml at screening and liver biopsy consistent with chronic hcv infection
boolean
C0021212 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0524910 (UMLS CUI [1,3])
C0166049 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
C1272251 (UMLS CUI [3])
C0855842 (UMLS CUI [4])
C0193388 (UMLS CUI [5,1])
C0332290 (UMLS CUI [5,2])
C0524910 (UMLS CUI [5,3])
Laboratory Results Indication of Hepatitis C genotype
Item
subject has a screening laboratory result indicating hcv genotype 1-infection
boolean
C1254595 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0019196 (UMLS CUI [1,3])
C1148363 (UMLS CUI [1,4])
Exclusion Criteria Main
Item
key exclusion criteria
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
subject, if female is pregnant or is breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Hepatitis B surface antigen positive | HIV antibody positive
Item
subject has positive test result for hepatitis b surface antigen or confirmed positive anti-hiv antibody test
boolean
C0149709 (UMLS CUI [1])
C0920548 (UMLS CUI [2])
Contraindicated drug Study Protocol
Item
subject received study contraindicated medications prior to study drug administration
boolean
C3845816 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
CYP3A Inducers | CYP2C8 Inducers | CYP2C8 Inhibitors
Item
use of known strong inducers of cytochrome p450 3a (cyp3a) or strong inducers of cytochrome p450 2c8 (cyp2c8) or strong inhibitors of cyp2c8 within 2 weeks of the respective medication/supplement prior to initial dose of study drug.
boolean
C3850044 (UMLS CUI [1])
C3850048 (UMLS CUI [2])
C3850061 (UMLS CUI [3])
Abnormality Study Subject Participation Status Inappropriate | Comorbidity Study Subject Participation Status Inappropriate
Item
clinically significant abnormalities or co-morbidities, other than hcv infection that in opinion of the investigator makes subject unsuitable for this study or drug regimen
boolean
C1704258 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1548788 (UMLS CUI [1,3])
C0009488 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C1548788 (UMLS CUI [2,3])
Study Subject Participation Status | Interventional Study | Investigational New Drugs Against Hepatitis C | Exception Interferon | Exception Ribavirin | Exposure to ABT-450 | Exposure to Paritaprevir | Exposure to ABT-267 | Exposure to Ombitasvir | Exposure to ABT-333 | Exposure to Dasabuvir
Item
current enrollment in another interventional clinical study or prior or current use of any investigational or commercially available anti-hcv agents other than interferon or ribavirin including previous exposure to abt450 (paritaprevir) , abt-267 (ombitasvir) or abt-333 (dasabuvir) or receipt of any investigational product within 6 weeks prior to study drug administration
boolean
C2348568 (UMLS CUI [1])
C3274035 (UMLS CUI [2])
C0013230 (UMLS CUI [3,1])
C0521124 (UMLS CUI [3,2])
C0019196 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C3652465 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0035525 (UMLS CUI [5,2])
C0332157 (UMLS CUI [6,1])
C3712108 (UMLS CUI [6,2])
C0332157 (UMLS CUI [7,1])
C3864824 (UMLS CUI [7,2])
C0332157 (UMLS CUI [8,1])
C3713322 (UMLS CUI [8,2])
C0332157 (UMLS CUI [9,1])
C3852670 (UMLS CUI [9,2])
C0332157 (UMLS CUI [10,1])
C3850285 (UMLS CUI [10,2])
C0332157 (UMLS CUI [11,1])
C3852512 (UMLS CUI [11,2])
Prior Therapy Chronic Hepatitis C | DIRECT ACTING ANTIVIRALS | telaprevir | boceprevir | sofosbuvir | simeprevir
Item
prior treatment of chronic hcv infection with a direct acting antiviral agent(s): telaprevir, boceprevir, sofosbuvir, simeprevir, or other direct acting antiviral
boolean
C1514463 (UMLS CUI [1,1])
C0524910 (UMLS CUI [1,2])
C3653501 (UMLS CUI [2])
C1876229 (UMLS CUI [3])
C1738934 (UMLS CUI [4])
C2976303 (UMLS CUI [5])
C2605855 (UMLS CUI [6])
Solid organ transplant
Item
history of solid organ transplant
boolean
C0730400 (UMLS CUI [1])
Liver Cirrhosis
Item
evidence of cirrhosis
boolean
C0023890 (UMLS CUI [1])
Hepatic decompensation | Ascites Physical Examination | Ascites Imaging | Ascites Test | Bleeding varices | Hepatic Encephalopathy
Item
history of liver decompensation: ascites noted on a physical exam, imaging or other test; variceal bleeding; hepatic encephalopathy
boolean
C1394798 (UMLS CUI [1])
C0003962 (UMLS CUI [2,1])
C0031809 (UMLS CUI [2,2])
C0003962 (UMLS CUI [3,1])
C0011923 (UMLS CUI [3,2])
C0003962 (UMLS CUI [4,1])
C0456984 (UMLS CUI [4,2])
C0333106 (UMLS CUI [5])
C0019151 (UMLS CUI [6])
Liver carcinoma Computed Tomography | Liver carcinoma Magnetic Resonance Imaging | Liver carcinoma Imaging Technique
Item
confirmed presence of hepatocellular carcinoma indicated on computed tomography, magnetic resonance, or other imaging techniques within 3 months prior to screening
boolean
C2239176 (UMLS CUI [1,1])
C0040405 (UMLS CUI [1,2])
C2239176 (UMLS CUI [2,1])
C0024485 (UMLS CUI [2,2])
C2239176 (UMLS CUI [3,1])
C0079595 (UMLS CUI [3,2])
Hepatitis C virus genotype determination | Hepatitis C Genotype | Exception Genotype Specified
Item
hcv genotype performed during screening indicates infection with any genotype other than genotype 1
boolean
C1533728 (UMLS CUI [1])
C0019196 (UMLS CUI [2,1])
C1148363 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C1148363 (UMLS CUI [3,2])
C0205369 (UMLS CUI [3,3])
Substance Use Disorders Affecting Protocol Compliance
Item
recent history of drug or alcohol abuse that could, in the opinion of the investigator, affect adherence to the study protocol
boolean
C0038586 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
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