ID

36006

Beschrijving

Phase III Daclatasvir and Sofosbuvir for Genotype 3 Chronic HCV; ODM derived from: https://clinicaltrials.gov/show/NCT02032901

Link

https://clinicaltrials.gov/show/NCT02032901

Trefwoorden

Versies (1)
  1. 09-04-19 09-04-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

9 april 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Hepatitis C NCT02032901

Engels

Eligibility Hepatitis C NCT02032901

1 Formulieren  
Criteria
Beschrijving

Criteria

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects must be able to understand and agree to comply with the prescribed dosing regimens and procedures, report for regularly scheduled study visits, and reliably communicate with study personnel about adverse events and concomitant medications
Beschrijving

Protocol Compliance | Able to communicate Research Personnel

Datatype

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2,1]
C2364293
UMLS CUI [2,2]
C0035173
subjects chronically infected with hcv genotype 3
Beschrijving

Chronic Hepatitis C Genotype

Datatype

boolean

Alias
UMLS CUI [1,1]
C0524910
UMLS CUI [1,2]
C1285573
subjects who are hcv-treatment-naive
Beschrijving

Therapy naive Hepatitis C

Datatype

boolean

Alias
UMLS CUI [1,1]
C0919936
UMLS CUI [1,2]
C0019196
subjects who are hcv-treatment-experienced
Beschrijving

Therapy Experience Hepatitis C

Datatype

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0596545
UMLS CUI [1,3]
C0019196
previous exposure to non-structural 5a (ns5a) inhibitors is prohibited
Beschrijving

Exposure to NS5A Inhibitor Illicit

Datatype

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C3883357
UMLS CUI [1,3]
C0332266
hcv rna ≥ 10,000 iu/ml at screening
Beschrijving

Hepatitis C virus RNA assay

Datatype

boolean

Alias
UMLS CUI [1]
C1272251
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
hcv genotypes other than genotype (gt) -3 infection; mixed genotype infections are not permitted
Beschrijving

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

Datatype

boolean

Alias
UMLS CUI [1]
C1148363
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1148363
UMLS CUI [2,3]
C0205369
UMLS CUI [3,1]
C0019196
UMLS CUI [3,2]
C0017431
UMLS CUI [3,3]
C0205430
liver or any other organ transplant (including hematopoietic stem cell transplants) other than cornea and hair
Beschrijving

Transplantation of liver | Organ Transplantation | Hemopoietic stem cell transplant | Exception Keratoplasty | Exception Hair transplant

Datatype

boolean

Alias
UMLS CUI [1]
C0023911
UMLS CUI [2]
C0029216
UMLS CUI [3]
C0472699
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0010042
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0191626
current or known history of cancer (except in situ carcinoma of the cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to screening
Beschrijving

Malignant Neoplasms | Exception Carcinoma in situ of uterine cervix | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated

Datatype

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0851140
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007117
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0553723
UMLS CUI [4,3]
C1522326
documented or suspected hepatocellular carcinoma (hcc), as evidenced by previously obtained imaging studies or liver biopsy (or on a screening imaging study/liver biopsy if this was performed)
Beschrijving

Liver carcinoma Imaging study | Liver carcinoma Suspected Imaging study | Liver carcinoma Biopsy of liver | Liver carcinoma Suspected Biopsy of liver

Datatype

boolean

Alias
UMLS CUI [1,1]
C2239176
UMLS CUI [1,2]
C1881134
UMLS CUI [2,1]
C2239176
UMLS CUI [2,2]
C0750491
UMLS CUI [2,3]
C1881134
UMLS CUI [3,1]
C2239176
UMLS CUI [3,2]
C0193388
UMLS CUI [4,1]
C2239176
UMLS CUI [4,2]
C0750491
UMLS CUI [4,3]
C0193388
evidence of decompensated liver disease including, but not limited to, radiologic criteria, a history or presence of ascites, bleeding varices, or hepatic encephalopathy
Beschrijving

Decompensated liver disease | Criteria Radiologic | Ascites | Bleeding varices | Hepatic Encephalopathy

Datatype

boolean

Alias
UMLS CUI [1]
C4075847
UMLS CUI [2,1]
C0243161
UMLS CUI [2,2]
C0205483
UMLS CUI [3]
C0003962
UMLS CUI [4]
C0333106
UMLS CUI [5]
C0019151
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Similar models

Eligibility Hepatitis C NCT02032901

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Item Group
C1512693 (UMLS CUI)
Protocol Compliance | Able to communicate Research Personnel
Item
subjects must be able to understand and agree to comply with the prescribed dosing regimens and procedures, report for regularly scheduled study visits, and reliably communicate with study personnel about adverse events and concomitant medications
boolean
C0525058 (UMLS CUI [1])
C2364293 (UMLS CUI [2,1])
C0035173 (UMLS CUI [2,2])
Chronic Hepatitis C Genotype
Item
subjects chronically infected with hcv genotype 3
boolean
C0524910 (UMLS CUI [1,1])
C1285573 (UMLS CUI [1,2])
Therapy naive Hepatitis C
Item
subjects who are hcv-treatment-naive
boolean
C0919936 (UMLS CUI [1,1])
C0019196 (UMLS CUI [1,2])
Therapy Experience Hepatitis C
Item
subjects who are hcv-treatment-experienced
boolean
C0087111 (UMLS CUI [1,1])
C0596545 (UMLS CUI [1,2])
C0019196 (UMLS CUI [1,3])
Exposure to NS5A Inhibitor Illicit
Item
previous exposure to non-structural 5a (ns5a) inhibitors is prohibited
boolean
C0332157 (UMLS CUI [1,1])
C3883357 (UMLS CUI [1,2])
C0332266 (UMLS CUI [1,3])
Hepatitis C virus RNA assay
Item
hcv rna ≥ 10,000 iu/ml at screening
boolean
C1272251 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Hepatitis C virus genotype | Exception Hepatitis C virus genotype Specified | Hepatitis C Genotype Mixed
Item
hcv genotypes other than genotype (gt) -3 infection; mixed genotype infections are not permitted
boolean
C1148363 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1148363 (UMLS CUI [2,2])
C0205369 (UMLS CUI [2,3])
C0019196 (UMLS CUI [3,1])
C0017431 (UMLS CUI [3,2])
C0205430 (UMLS CUI [3,3])
Transplantation of liver | Organ Transplantation | Hemopoietic stem cell transplant | Exception Keratoplasty | Exception Hair transplant
Item
liver or any other organ transplant (including hematopoietic stem cell transplants) other than cornea and hair
boolean
C0023911 (UMLS CUI [1])
C0029216 (UMLS CUI [2])
C0472699 (UMLS CUI [3])
C1705847 (UMLS CUI [4,1])
C0010042 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0191626 (UMLS CUI [5,2])
Malignant Neoplasms | Exception Carcinoma in situ of uterine cervix | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated
Item
current or known history of cancer (except in situ carcinoma of the cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to screening
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0851140 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0553723 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
Liver carcinoma Imaging study | Liver carcinoma Suspected Imaging study | Liver carcinoma Biopsy of liver | Liver carcinoma Suspected Biopsy of liver
Item
documented or suspected hepatocellular carcinoma (hcc), as evidenced by previously obtained imaging studies or liver biopsy (or on a screening imaging study/liver biopsy if this was performed)
boolean
C2239176 (UMLS CUI [1,1])
C1881134 (UMLS CUI [1,2])
C2239176 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C1881134 (UMLS CUI [2,3])
C2239176 (UMLS CUI [3,1])
C0193388 (UMLS CUI [3,2])
C2239176 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
C0193388 (UMLS CUI [4,3])
Decompensated liver disease | Criteria Radiologic | Ascites | Bleeding varices | Hepatic Encephalopathy
Item
evidence of decompensated liver disease including, but not limited to, radiologic criteria, a history or presence of ascites, bleeding varices, or hepatic encephalopathy
boolean
C4075847 (UMLS CUI [1])
C0243161 (UMLS CUI [2,1])
C0205483 (UMLS CUI [2,2])
C0003962 (UMLS CUI [3])
C0333106 (UMLS CUI [4])
C0019151 (UMLS CUI [5])
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