ID

35267

Descrição

ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 in Treatment-Naïve and Treatment-Experienced, Non-Cirrhotic Asian Adults With Subgenotype 1b Chronic Hepatitis C Virus (HCV) Infection; ODM derived from: https://clinicaltrials.gov/show/NCT02517515

Link

https://clinicaltrials.gov/show/NCT02517515

Palavras-chave

Versões (1)
  1. 25/02/2019 25/02/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

25 de fevereiro de 2019

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Chronic Hepatitis C Virus NCT02517515

Inglês

Eligibility Chronic Hepatitis C Virus NCT02517515

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. chinese, south korean, and taiwanese descent with full chinese, south korean, and taiwanese parentage
Descrição

Chinese | Born in South Korea | Taiwanese

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0152035
UMLS CUI [2]
C1277434
UMLS CUI [3]
C1556096
2. chronic hcv-infection prior to study enrollment.
Descrição

Hepatitis C, Chronic

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0524910
3. screening laboratory result indicating hcv gt 1b infection.
Descrição

Hepatitis C Genotype

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0019196
UMLS CUI [1,2]
C0017431
4. per local standard practice, documented results of one of the following:
Descrição

Result

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1274040
liver biopsy within 24 months prior to or during screening demonstrating the absence of cirrhosis, e.g., a metavir score of ≤ 3 or an ishak score of ≤ 4; or
Descrição

Liver Cirrhosis Absent Biopsy of liver | Metavir score f4 | Ishak Score

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0023890
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0193388
UMLS CUI [2]
C4481041
UMLS CUI [3]
C2986945
a screening fibrotest score of ≤ 0.72 and aspartate aminotransferase to platelet ratio index (apri) ≤ 2; or
Descrição

FibroTest Score Measurement | AST to platelet ratio index

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3642160
UMLS CUI [2]
C4483916
a screening fibroscan result of < 9.6 kpa. (participants with a non-qualifying fibrotest/apri or fibroscan result may only be enrolled if they have a qualifying liver biopsy performed within 24 months prior to or during screening.)
Descrição

Fibroscan

Tipo de dados

boolean

Alias
UMLS CUI [1]
C4522043
5. participant has never received antiviral treatment (including ifn-based therapy [ifn (alpha, beta or pegifn) with or without rbv]) for hepatitis c infection (treatment-naïve participant) or participant must have documentation that they met the definition of one of the following categories (treatment experienced participant):
Descrição

Antiviral Therapy Absent Hepatitis C | Interferon Absent | Interferon-alpha Absent | Interferon-beta Absent | PEGINTERFERON Absent | Absence Interferon With Ribavirin

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0280274
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0019196
UMLS CUI [2,1]
C3652465
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0002199
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0015980
UMLS CUI [4,2]
C0332197
UMLS CUI [5,1]
C0982327
UMLS CUI [5,2]
C0332197
UMLS CUI [6,1]
C0332197
UMLS CUI [6,2]
C3652465
UMLS CUI [6,3]
C0332287
UMLS CUI [6,4]
C0035525
non-responder or relapser
Descrição

Therapy non-responder | Recurrent disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0919875
UMLS CUI [2]
C0277556
6. participant has plasma hcv rna level > 10,000 iu/ml at screening.
Descrição

Plasma Hepatitis C virus RNA Level

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0032105
UMLS CUI [1,2]
C0369335
UMLS CUI [1,3]
C0441889
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. hcv genotype performed during screening indicating unable to genotype or infection with any other hcv genotype.
Descrição

Hepatitis C virus genotype determination

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1533728
2. positive test result at screening for hepatitis b surface antigen (hbsag), or hbv-dna > lower limit of quantification (lloq) if hbsag negative, or anti-human immunodeficiency virus antibody (hiv ab).
Descrição

Hepatitis B surface antigen positive | Hbv DNA Test | HIV Antibody Measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0149709
UMLS CUI [2]
C1256114
UMLS CUI [3]
C3714540
3. any current or past clinical evidence of cirrhosis such as ascites or esophageal varices, or prior biopsy showing cirrhosis, e.g., a metavir score of > 3 or ishak score of > 4.
Descrição

Liver Cirrhosis | Ascites | Esophageal Varices | Liver Cirrhosis Biopsy Previous | Metavir score f4 | Ishak Score

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023890
UMLS CUI [2]
C0003962
UMLS CUI [3]
C0014867
UMLS CUI [4,1]
C0023890
UMLS CUI [4,2]
C0005558
UMLS CUI [4,3]
C0205156
UMLS CUI [5]
C4481041
UMLS CUI [6]
C2986945
4. any primary cause of liver disease other than chronic hcv infection, including but not limited to the following:
Descrição

Cause Primary Liver disease | Exception Chronic Hepatitis C

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0015127
UMLS CUI [1,2]
C0205225
UMLS CUI [1,3]
C0023895
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0524910
hemochromatosis
Descrição

Hemochromatosis

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0018995
alpha-1 antitrypsin deficiency
Descrição

alpha 1-Antitrypsin Deficiency

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0221757
wilson's disease
Descrição

Hepatolenticular Degeneration

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0019202
autoimmune hepatitis
Descrição

Hepatitis, Autoimmune

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0241910
alcoholic liver disease
Descrição

Alcoholic Liver Disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023896
drug-related liver disease steatosis and steatohepatitis on a liver biopsy coincident with hcv-related changes would not be considered exclusionary unless the steatohepatitis is considered to be the primary cause of the liver disease.
Descrição

Drug-Induced Liver Disease | Fatty degeneration | Steatohepatitis

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0860207
UMLS CUI [2]
C0152254
UMLS CUI [3]
C2711227
5. screening laboratory analyses showing abnormal kidney, hepatic, or hematologic function.
Descrição

Abnormal renal function | Liver Dysfunction | Hematologic function Abnormal

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0151746
UMLS CUI [2]
C0086565
UMLS CUI [3,1]
C0221130
UMLS CUI [3,2]
C0205161
6. use of known strong inducers of cytochrome p450 3a (cyp3a) or strong inhibitors of cyp2c8 within 2 weeks or within 10 half-lives, whichever is longer, of the respective medication/supplement prior to study drug administration.
Descrição

CYP3A Inducers | CYP2C8 Inhibitors

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3850044
UMLS CUI [2]
C3850061
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Similar models

Eligibility Chronic Hepatitis C Virus NCT02517515

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Chinese | Born in South Korea | Taiwanese
Item
1. chinese, south korean, and taiwanese descent with full chinese, south korean, and taiwanese parentage
boolean
C0152035 (UMLS CUI [1])
C1277434 (UMLS CUI [2])
C1556096 (UMLS CUI [3])
Hepatitis C, Chronic
Item
2. chronic hcv-infection prior to study enrollment.
boolean
C0524910 (UMLS CUI [1])
Hepatitis C Genotype
Item
3. screening laboratory result indicating hcv gt 1b infection.
boolean
C0019196 (UMLS CUI [1,1])
C0017431 (UMLS CUI [1,2])
Result
Item
4. per local standard practice, documented results of one of the following:
boolean
C1274040 (UMLS CUI [1])
Liver Cirrhosis Absent Biopsy of liver | Metavir score f4 | Ishak Score
Item
liver biopsy within 24 months prior to or during screening demonstrating the absence of cirrhosis, e.g., a metavir score of ≤ 3 or an ishak score of ≤ 4; or
boolean
C0023890 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0193388 (UMLS CUI [1,3])
C4481041 (UMLS CUI [2])
C2986945 (UMLS CUI [3])
FibroTest Score Measurement | AST to platelet ratio index
Item
a screening fibrotest score of ≤ 0.72 and aspartate aminotransferase to platelet ratio index (apri) ≤ 2; or
boolean
C3642160 (UMLS CUI [1])
C4483916 (UMLS CUI [2])
Fibroscan
Item
a screening fibroscan result of < 9.6 kpa. (participants with a non-qualifying fibrotest/apri or fibroscan result may only be enrolled if they have a qualifying liver biopsy performed within 24 months prior to or during screening.)
boolean
C4522043 (UMLS CUI [1])
Antiviral Therapy Absent Hepatitis C | Interferon Absent | Interferon-alpha Absent | Interferon-beta Absent | PEGINTERFERON Absent | Absence Interferon With Ribavirin
Item
5. participant has never received antiviral treatment (including ifn-based therapy [ifn (alpha, beta or pegifn) with or without rbv]) for hepatitis c infection (treatment-naïve participant) or participant must have documentation that they met the definition of one of the following categories (treatment experienced participant):
boolean
C0280274 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0019196 (UMLS CUI [1,3])
C3652465 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0002199 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0015980 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0982327 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C0332197 (UMLS CUI [6,1])
C3652465 (UMLS CUI [6,2])
C0332287 (UMLS CUI [6,3])
C0035525 (UMLS CUI [6,4])
Therapy non-responder | Recurrent disease
Item
non-responder or relapser
boolean
C0919875 (UMLS CUI [1])
C0277556 (UMLS CUI [2])
Plasma Hepatitis C virus RNA Level
Item
6. participant has plasma hcv rna level > 10,000 iu/ml at screening.
boolean
C0032105 (UMLS CUI [1,1])
C0369335 (UMLS CUI [1,2])
C0441889 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Hepatitis C virus genotype determination
Item
1. hcv genotype performed during screening indicating unable to genotype or infection with any other hcv genotype.
boolean
C1533728 (UMLS CUI [1])
Hepatitis B surface antigen positive | Hbv DNA Test | HIV Antibody Measurement
Item
2. positive test result at screening for hepatitis b surface antigen (hbsag), or hbv-dna > lower limit of quantification (lloq) if hbsag negative, or anti-human immunodeficiency virus antibody (hiv ab).
boolean
C0149709 (UMLS CUI [1])
C1256114 (UMLS CUI [2])
C3714540 (UMLS CUI [3])
Liver Cirrhosis | Ascites | Esophageal Varices | Liver Cirrhosis Biopsy Previous | Metavir score f4 | Ishak Score
Item
3. any current or past clinical evidence of cirrhosis such as ascites or esophageal varices, or prior biopsy showing cirrhosis, e.g., a metavir score of > 3 or ishak score of > 4.
boolean
C0023890 (UMLS CUI [1])
C0003962 (UMLS CUI [2])
C0014867 (UMLS CUI [3])
C0023890 (UMLS CUI [4,1])
C0005558 (UMLS CUI [4,2])
C0205156 (UMLS CUI [4,3])
C4481041 (UMLS CUI [5])
C2986945 (UMLS CUI [6])
Cause Primary Liver disease | Exception Chronic Hepatitis C
Item
4. any primary cause of liver disease other than chronic hcv infection, including but not limited to the following:
boolean
C0015127 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C0023895 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0524910 (UMLS CUI [2,2])
Hemochromatosis
Item
hemochromatosis
boolean
C0018995 (UMLS CUI [1])
alpha 1-Antitrypsin Deficiency
Item
alpha-1 antitrypsin deficiency
boolean
C0221757 (UMLS CUI [1])
Hepatolenticular Degeneration
Item
wilson's disease
boolean
C0019202 (UMLS CUI [1])
Hepatitis, Autoimmune
Item
autoimmune hepatitis
boolean
C0241910 (UMLS CUI [1])
Alcoholic Liver Disease
Item
alcoholic liver disease
boolean
C0023896 (UMLS CUI [1])
Drug-Induced Liver Disease | Fatty degeneration | Steatohepatitis
Item
drug-related liver disease steatosis and steatohepatitis on a liver biopsy coincident with hcv-related changes would not be considered exclusionary unless the steatohepatitis is considered to be the primary cause of the liver disease.
boolean
C0860207 (UMLS CUI [1])
C0152254 (UMLS CUI [2])
C2711227 (UMLS CUI [3])
Abnormal renal function | Liver Dysfunction | Hematologic function Abnormal
Item
5. screening laboratory analyses showing abnormal kidney, hepatic, or hematologic function.
boolean
C0151746 (UMLS CUI [1])
C0086565 (UMLS CUI [2])
C0221130 (UMLS CUI [3,1])
C0205161 (UMLS CUI [3,2])
CYP3A Inducers | CYP2C8 Inhibitors
Item
6. use of known strong inducers of cytochrome p450 3a (cyp3a) or strong inhibitors of cyp2c8 within 2 weeks or within 10 half-lives, whichever is longer, of the respective medication/supplement prior to study drug administration.
boolean
C3850044 (UMLS CUI [1])
C3850061 (UMLS CUI [2])
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