ID

44161

Descripción

Collection of Plasma and Serum Samples From Individuals Initiating Sofosbuvir for Chronic Hepatitis C for Testing; ODM derived from: https://clinicaltrials.gov/show/NCT02068963

Link

https://clinicaltrials.gov/show/NCT02068963

Palabras clave

Versiones (2)
  1. 9/4/19 9/4/19 -
  2. 20/9/21 20/9/21 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

20 de septiembre de 2021

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Hepatitis C NCT02068963

Inglés

Eligibility Hepatitis C NCT02068963

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
the subject is chronically infected with hcv genotypes 1, 2, 3, 4, 5, and/or 6 as documented in the subject's medical records and is naïve to hcv treatment (treatment naïve).
Descripción

Chronic Hepatitis C Genotype | Therapy naive Hepatitis C

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0524910
UMLS CUI [1,2]
C1285573
UMLS CUI [2,1]
C0919936
UMLS CUI [2,2]
C0019196
chronic hcv (with or without hiv [human immunodeficiency virus] co-infection) will be documented with historical record of:
Descripción

Hepatitis C, Chronic | HIV coinfection | HIV coinfection Absent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0524910
UMLS CUI [2]
C4062778
UMLS CUI [3,1]
C4062778
UMLS CUI [3,2]
C0332197
a positive hcv rna test result (result generated at least 6 months before the baseline visit)
Descripción

Hepatitis C RNA positive

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0855842
a hcv genotype test result (result generated at least 6 months before the baseline visit)
Descripción

Hepatitis c viral genotype

Tipo de datos

boolean

Alias
UMLS CUI [1]
C4272868
a liver biopsy report demonstrating chronic hcv
Descripción

Chronic Hepatitis C Biopsy of liver

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0524910
UMLS CUI [1,2]
C0193388
--the subject is initiating antiviral therapy with a sofosbuvir regimen as indicated below:
Descripción

Antiviral Therapy | sofosbuvir

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0280274
UMLS CUI [2]
C2976303
sofosbuvir plus peginterferon and ribavirin for 12 weeks (peginterferon eligible genotype 1, 4, 5, or 6)
Descripción

Sofosbuvir Plus PEGINTERFERON Plus Ribavirin | PEGINTERFERON Eligible Genotype

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2976303
UMLS CUI [1,2]
C0332287
UMLS CUI [1,3]
C0982327
UMLS CUI [1,4]
C0332287
UMLS CUI [1,5]
C0035525
UMLS CUI [2,1]
C0982327
UMLS CUI [2,2]
C1548635
UMLS CUI [2,3]
C1285573
sofosbuvir plus ribavirin for 12 weeks (genotype 2)
Descripción

Sofosbuvir Plus Ribavirin | Genotype

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2976303
UMLS CUI [1,2]
C0332287
UMLS CUI [1,3]
C0035525
UMLS CUI [2]
C1285573
sofosbuvir plus ribavirin for 24 weeks (peginterferon ineligible or unwilling genotype 1 or genotype 3)
Descripción

Sofosbuvir Plus Ribavirin | PEGINTERFERON Ineligible Genotype | PEGINTERFERON Unwilling Genotype

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2976303
UMLS CUI [1,2]
C0332287
UMLS CUI [1,3]
C0035525
UMLS CUI [2,1]
C0982327
UMLS CUI [2,2]
C1512714
UMLS CUI [2,3]
C1285573
UMLS CUI [3,1]
C0982327
UMLS CUI [3,2]
C0558080
UMLS CUI [3,3]
C1285573
the subject is at least 18 years of age at the time of enrollment
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
adequate medical records are available for collection of protocol-defined demographics, baseline patient characteristics, medical history, virology and specific laboratory results, and other information to verify enrollment criteria
Descripción

Availability of Medical Records | Demography | Client Characteristics | Medical History | Virology | Laboratory Results

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0470187
UMLS CUI [1,2]
C0025102
UMLS CUI [2]
C0011298
UMLS CUI [3]
C0815172
UMLS CUI [4]
C0262926
UMLS CUI [5]
C0042762
UMLS CUI [6]
C1254595
the subject and/or legally authorized representative is willing and able to provide consent prior to providing a specimen(s)
Descripción

Informed Consent | Informed Consent Patient Representative

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0030701
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects with history or evidence of decompensated liver disease
Descripción

Decompensated liver disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C4075847
subjects with severe renal impairment or end stage renal disease
Descripción

Renal Insufficiency Severe | Kidney Failure, Chronic

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1565489
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0022661
subjects who are not naïve to hcv therapy with prior exposure to an approved or experimental hcv antiviral therapy
Descripción

Therapy Hepatitis C | Antiviral Therapy Hepatitis C | Antiviral Therapy Investigational Hepatitis C

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0019196
UMLS CUI [2,1]
C0280274
UMLS CUI [2,2]
C0019196
UMLS CUI [3,1]
C0280274
UMLS CUI [3,2]
C1517586
UMLS CUI [3,3]
C0019196
subject has characteristics that are contraindicated in the fda approved label for sofosbuvir (eg, subjects with contraindications applicable to peginterferon and/or ribavirin, pregnant woman or men whose female partners are pregnant; sovaldi package insert 2013)
Descripción

Medical contraindication Sofosbuvir | Medical contraindication PEGINTERFERON | Medical contraindication Ribavirin | Pregnancy | Gender Partner Pregnancy | Sovaldi

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C2976303
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0982327
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C0035525
UMLS CUI [4]
C0032961
UMLS CUI [5,1]
C0079399
UMLS CUI [5,2]
C0682323
UMLS CUI [5,3]
C0032961
UMLS CUI [6]
C3700471
subject is receiving treatment pre- or post-transplant
Descripción

Therapy Before Transplantation | Therapy Post Transplantation

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C0040732
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0687676
UMLS CUI [2,3]
C0040732
subject is unsuitable for study participation based on the investigator's decision (eg, unlikely to comply with study visit schedule, significant medical complication)
Descripción

Study Subject Participation Status Inappropriate | Compliance behavior Unlikely | Medical complication

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1548788
UMLS CUI [2,1]
C1321605
UMLS CUI [2,2]
C0750558
UMLS CUI [3]
C0009566
participating in another investigational study that the investigator believes might interfere with the subject's participation in this study
Descripción

Study Subject Participation Status Interferes with Clinical Trial

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0008976
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Similar models

Eligibility Hepatitis C NCT02068963

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Chronic Hepatitis C Genotype | Therapy naive Hepatitis C
Item
the subject is chronically infected with hcv genotypes 1, 2, 3, 4, 5, and/or 6 as documented in the subject's medical records and is naïve to hcv treatment (treatment naïve).
boolean
C0524910 (UMLS CUI [1,1])
C1285573 (UMLS CUI [1,2])
C0919936 (UMLS CUI [2,1])
C0019196 (UMLS CUI [2,2])
Hepatitis C, Chronic | HIV coinfection | HIV coinfection Absent
Item
chronic hcv (with or without hiv [human immunodeficiency virus] co-infection) will be documented with historical record of:
boolean
C0524910 (UMLS CUI [1])
C4062778 (UMLS CUI [2])
C4062778 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Hepatitis C RNA positive
Item
a positive hcv rna test result (result generated at least 6 months before the baseline visit)
boolean
C0855842 (UMLS CUI [1])
Hepatitis c viral genotype
Item
a hcv genotype test result (result generated at least 6 months before the baseline visit)
boolean
C4272868 (UMLS CUI [1])
Chronic Hepatitis C Biopsy of liver
Item
a liver biopsy report demonstrating chronic hcv
boolean
C0524910 (UMLS CUI [1,1])
C0193388 (UMLS CUI [1,2])
Antiviral Therapy | sofosbuvir
Item
--the subject is initiating antiviral therapy with a sofosbuvir regimen as indicated below:
boolean
C0280274 (UMLS CUI [1])
C2976303 (UMLS CUI [2])
Sofosbuvir Plus PEGINTERFERON Plus Ribavirin | PEGINTERFERON Eligible Genotype
Item
sofosbuvir plus peginterferon and ribavirin for 12 weeks (peginterferon eligible genotype 1, 4, 5, or 6)
boolean
C2976303 (UMLS CUI [1,1])
C0332287 (UMLS CUI [1,2])
C0982327 (UMLS CUI [1,3])
C0332287 (UMLS CUI [1,4])
C0035525 (UMLS CUI [1,5])
C0982327 (UMLS CUI [2,1])
C1548635 (UMLS CUI [2,2])
C1285573 (UMLS CUI [2,3])
Sofosbuvir Plus Ribavirin | Genotype
Item
sofosbuvir plus ribavirin for 12 weeks (genotype 2)
boolean
C2976303 (UMLS CUI [1,1])
C0332287 (UMLS CUI [1,2])
C0035525 (UMLS CUI [1,3])
C1285573 (UMLS CUI [2])
Sofosbuvir Plus Ribavirin | PEGINTERFERON Ineligible Genotype | PEGINTERFERON Unwilling Genotype
Item
sofosbuvir plus ribavirin for 24 weeks (peginterferon ineligible or unwilling genotype 1 or genotype 3)
boolean
C2976303 (UMLS CUI [1,1])
C0332287 (UMLS CUI [1,2])
C0035525 (UMLS CUI [1,3])
C0982327 (UMLS CUI [2,1])
C1512714 (UMLS CUI [2,2])
C1285573 (UMLS CUI [2,3])
C0982327 (UMLS CUI [3,1])
C0558080 (UMLS CUI [3,2])
C1285573 (UMLS CUI [3,3])
Age
Item
the subject is at least 18 years of age at the time of enrollment
boolean
C0001779 (UMLS CUI [1])
Availability of Medical Records | Demography | Client Characteristics | Medical History | Virology | Laboratory Results
Item
adequate medical records are available for collection of protocol-defined demographics, baseline patient characteristics, medical history, virology and specific laboratory results, and other information to verify enrollment criteria
boolean
C0470187 (UMLS CUI [1,1])
C0025102 (UMLS CUI [1,2])
C0011298 (UMLS CUI [2])
C0815172 (UMLS CUI [3])
C0262926 (UMLS CUI [4])
C0042762 (UMLS CUI [5])
C1254595 (UMLS CUI [6])
Informed Consent | Informed Consent Patient Representative
Item
the subject and/or legally authorized representative is willing and able to provide consent prior to providing a specimen(s)
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030701 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Decompensated liver disease
Item
subjects with history or evidence of decompensated liver disease
boolean
C4075847 (UMLS CUI [1])
Renal Insufficiency Severe | Kidney Failure, Chronic
Item
subjects with severe renal impairment or end stage renal disease
boolean
C1565489 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0022661 (UMLS CUI [2])
Therapy Hepatitis C | Antiviral Therapy Hepatitis C | Antiviral Therapy Investigational Hepatitis C
Item
subjects who are not naïve to hcv therapy with prior exposure to an approved or experimental hcv antiviral therapy
boolean
C0087111 (UMLS CUI [1,1])
C0019196 (UMLS CUI [1,2])
C0280274 (UMLS CUI [2,1])
C0019196 (UMLS CUI [2,2])
C0280274 (UMLS CUI [3,1])
C1517586 (UMLS CUI [3,2])
C0019196 (UMLS CUI [3,3])
Medical contraindication Sofosbuvir | Medical contraindication PEGINTERFERON | Medical contraindication Ribavirin | Pregnancy | Gender Partner Pregnancy | Sovaldi
Item
subject has characteristics that are contraindicated in the fda approved label for sofosbuvir (eg, subjects with contraindications applicable to peginterferon and/or ribavirin, pregnant woman or men whose female partners are pregnant; sovaldi package insert 2013)
boolean
C1301624 (UMLS CUI [1,1])
C2976303 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0982327 (UMLS CUI [2,2])
C1301624 (UMLS CUI [3,1])
C0035525 (UMLS CUI [3,2])
C0032961 (UMLS CUI [4])
C0079399 (UMLS CUI [5,1])
C0682323 (UMLS CUI [5,2])
C0032961 (UMLS CUI [5,3])
C3700471 (UMLS CUI [6])
Therapy Before Transplantation | Therapy Post Transplantation
Item
subject is receiving treatment pre- or post-transplant
boolean
C0087111 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C0040732 (UMLS CUI [1,3])
C0087111 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C0040732 (UMLS CUI [2,3])
Study Subject Participation Status Inappropriate | Compliance behavior Unlikely | Medical complication
Item
subject is unsuitable for study participation based on the investigator's decision (eg, unlikely to comply with study visit schedule, significant medical complication)
boolean
C2348568 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C1321605 (UMLS CUI [2,1])
C0750558 (UMLS CUI [2,2])
C0009566 (UMLS CUI [3])
Study Subject Participation Status Interferes with Clinical Trial
Item
participating in another investigational study that the investigator believes might interfere with the subject's participation in this study
boolean
C2348568 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
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