ID

35259

Beschrijving

Ombitasvir/ABT-450/Ritonavir (Ombitasvir/ABT-450/r) With Dasabuvir and Ribavirin (RBV) in Treatment Naive and Treatment Experienced Genotype 1a Hepatitis C Virus Infected Adults; ODM derived from: https://clinicaltrials.gov/show/NCT02476617

Link

https://clinicaltrials.gov/show/NCT02476617

Trefwoorden

Versies (1)
  1. 25-02-19 25-02-19 -
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See clinicaltrials.gov

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25 februari 2019

DOI

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Creative Commons BY 4.0
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Eligibility Chronic Hepatitis C NCT02476617

Engels

Eligibility Chronic Hepatitis C NCT02476617

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. screening laboratory result indicating hcv gt1a infection.
Beschrijving

Hepatitis C Genotype Laboratory test result

Datatype

boolean

Alias
UMLS CUI [1,1]
C0019196
UMLS CUI [1,2]
C0017431
UMLS CUI [1,3]
C0587081
2. chronic hcv infection.
Beschrijving

Hepatitis C, Chronic

Datatype

boolean

Alias
UMLS CUI [1]
C0524910
3. subjects must be non-cirrhotic.
Beschrijving

Study Subject Non-cirrhotic

Datatype

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0439687
4. subjects must be treatment-naïve or have documentation that they were adherent to prior pegifn/rbv combination therapy and meet the criteria of prior pegifn/rbv treatment failure.
Beschrijving

Therapy naive | PEGINTERFERON/RIBAVIRIN | PEGINTERFERON/RIBAVIRIN Treatment failure

Datatype

boolean

Alias
UMLS CUI [1]
C0919936
UMLS CUI [2]
C1875630
UMLS CUI [3,1]
C1875630
UMLS CUI [3,2]
C0162643
5. subjects must meet specific human leukocyte antigen (hla) allele requirements.
Beschrijving

Human leukocyte antigen allele Specific

Datatype

boolean

Alias
UMLS CUI [1,1]
C0555907
UMLS CUI [1,2]
C0205369
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. women who are pregnant or breastfeeding.
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
2. positive test result for hepatitis b surface antigen (hbsag) or anti-human immunodeficiency virus antibody (hiv ab) positive immunoassay.
Beschrijving

Hepatitis B surface antigen positive Immunoassay | HIV antibody positive Immunoassay

Datatype

boolean

Alias
UMLS CUI [1,1]
C0149709
UMLS CUI [1,2]
C0020980
UMLS CUI [2,1]
C0920548
UMLS CUI [2,2]
C0020980
3. clinically significant abnormalities or co-morbidities, other than hcv infection, that make the subject unsuitable for this study or treatment.
Beschrijving

Abnormality Study Subject Participation Status Inappropriate | Comorbidity Study Subject Participation Status Inappropriate | Exception Hepatitis C

Datatype

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
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0019196
4. current enrollment in another interventional clinical study, previous enrollment in this study, prior or current use of any investigational or commercially available anti-hcv agents other than pegifn or rbv (including previous exposure to abt-450, ombitasvir, or dasabuvir), or receipt of any investigational product within 6 weeks prior to study drug administration.
Beschrijving

Study Subject Participation Status | Interventional Study | Anti-hepatitis C (HCV) Agents | Exception PEGINTERFERON | Exception Ribavirin | Exposure to ABT-450 | Exposure to Ombitasvir | Exposure to Dasabuvir | Investigational New Drugs

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C3274035
UMLS CUI [3]
C4324240
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0982327
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]
C3852670
UMLS CUI [8,1]
C0332157
UMLS CUI [8,2]
C3852512
UMLS CUI [9]
C0013230
5. history or solid organ transplant.
Beschrijving

Solid organ transplant

Datatype

boolean

Alias
UMLS CUI [1]
C0730400
6. screening laboratory analysis that shows abnormal results.
Beschrijving

Laboratory test result abnormal

Datatype

boolean

Alias
UMLS CUI [1]
C0438215
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Similar models

Eligibility Chronic Hepatitis C NCT02476617

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Hepatitis C Genotype Laboratory test result
Item
1. screening laboratory result indicating hcv gt1a infection.
boolean
C0019196 (UMLS CUI [1,1])
C0017431 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,3])
Hepatitis C, Chronic
Item
2. chronic hcv infection.
boolean
C0524910 (UMLS CUI [1])
Study Subject Non-cirrhotic
Item
3. subjects must be non-cirrhotic.
boolean
C0681850 (UMLS CUI [1,1])
C0439687 (UMLS CUI [1,2])
Therapy naive | PEGINTERFERON/RIBAVIRIN | PEGINTERFERON/RIBAVIRIN Treatment failure
Item
4. subjects must be treatment-naïve or have documentation that they were adherent to prior pegifn/rbv combination therapy and meet the criteria of prior pegifn/rbv treatment failure.
boolean
C0919936 (UMLS CUI [1])
C1875630 (UMLS CUI [2])
C1875630 (UMLS CUI [3,1])
C0162643 (UMLS CUI [3,2])
Human leukocyte antigen allele Specific
Item
5. subjects must meet specific human leukocyte antigen (hla) allele requirements.
boolean
C0555907 (UMLS CUI [1,1])
C0205369 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
1. women who are pregnant or breastfeeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Hepatitis B surface antigen positive Immunoassay | HIV antibody positive Immunoassay
Item
2. positive test result for hepatitis b surface antigen (hbsag) or anti-human immunodeficiency virus antibody (hiv ab) positive immunoassay.
boolean
C0149709 (UMLS CUI [1,1])
C0020980 (UMLS CUI [1,2])
C0920548 (UMLS CUI [2,1])
C0020980 (UMLS CUI [2,2])
Abnormality Study Subject Participation Status Inappropriate | Comorbidity Study Subject Participation Status Inappropriate | Exception Hepatitis C
Item
3. clinically significant abnormalities or co-morbidities, other than hcv infection, that make the subject unsuitable for this study or treatment.
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])
C1705847 (UMLS CUI [3,1])
C0019196 (UMLS CUI [3,2])
Study Subject Participation Status | Interventional Study | Anti-hepatitis C (HCV) Agents | Exception PEGINTERFERON | Exception Ribavirin | Exposure to ABT-450 | Exposure to Ombitasvir | Exposure to Dasabuvir | Investigational New Drugs
Item
4. current enrollment in another interventional clinical study, previous enrollment in this study, prior or current use of any investigational or commercially available anti-hcv agents other than pegifn or rbv (including previous exposure to abt-450, ombitasvir, or dasabuvir), or receipt of any investigational product within 6 weeks prior to study drug administration.
boolean
C2348568 (UMLS CUI [1])
C3274035 (UMLS CUI [2])
C4324240 (UMLS CUI [3])
C1705847 (UMLS CUI [4,1])
C0982327 (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])
C3852670 (UMLS CUI [7,2])
C0332157 (UMLS CUI [8,1])
C3852512 (UMLS CUI [8,2])
C0013230 (UMLS CUI [9])
Solid organ transplant
Item
5. history or solid organ transplant.
boolean
C0730400 (UMLS CUI [1])
Laboratory test result abnormal
Item
6. screening laboratory analysis that shows abnormal results.
boolean
C0438215 (UMLS CUI [1])
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