ID

35260

Description

Ombitasvir/ABT-450/Ritonavir (Ombitasvir/ABT-450/r) and Dasabuvir Therapy With Low Dose Ribavirin (RBV), Full Dose RBV or RBV Add-On in Treatment Naive Genotype 1a Hepatitis C Virus Infected Adults; ODM derived from: https://clinicaltrials.gov/show/NCT02493855

Link

https://clinicaltrials.gov/show/NCT02493855

Keywords

Versions (1)
  1. 2/25/19 2/25/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 25, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Chronic Hepatitis C NCT02493855

English

Eligibility Chronic Hepatitis C NCT02493855

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. screening laboratory result indicating hcv genotype 1 (gt1) a infection.
Description

Hepatitis C Genotype Laboratory test result

Data type

boolean

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

Hepatitis C, Chronic

Data type

boolean

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

Study Subject Non-cirrhotic

Data type

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0439687
4. subjects must be able to understand and adhere to the study visit schedule and all protocol requirements as well as voluntarily sign and date an institutional review board (irb) approved informed consent.
Description

Protocol Compliance | Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

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

Pregnancy | Breast Feeding

Data type

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.
Description

Hepatitis B surface antigen positive Immunoassay | HIV antibody positive Immunoassay

Data type

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.
Description

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

Data type

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 use of any hcv treatments including pegylated interferon (pegifn), ribavirin, or any direct acting antiviral agent, either investigational or approved, for hcv including protease inhibitors, nucleoside or non-nucleoside polymerase inhibitors, or ns5a inhibitors.
Description

Study Subject Participation Status | Interventional Study | Therapeutic procedure Hepatitis C virus | PEGINTERFERON | Ribavirin | Antiviral Agents Investigational Hepatitis C virus | Antiviral Agents Hepatitis C virus | Protease Inhibitors | Other Coding | Hepatitis C Virus NS5A Inhibitor

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C3274035
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C0220847
UMLS CUI [4]
C0982327
UMLS CUI [5]
C0035525
UMLS CUI [6,1]
C0003451
UMLS CUI [6,2]
C1517586
UMLS CUI [6,3]
C0220847
UMLS CUI [7,1]
C0003451
UMLS CUI [7,2]
C0220847
UMLS CUI [8]
C0033607
UMLS CUI [9]
C3846158
UMLS CUI [10]
C3883357
5. history or solid organ transplant.
Description

Solid organ transplant

Data type

boolean

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

Laboratory test result abnormal

Data type

boolean

Alias
UMLS CUI [1]
C0438215
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Similar models

Eligibility Chronic Hepatitis C NCT02493855

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Hepatitis C Genotype Laboratory test result
Item
1. screening laboratory result indicating hcv genotype 1 (gt1) a 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])
Protocol Compliance | Informed Consent
Item
4. subjects must be able to understand and adhere to the study visit schedule and all protocol requirements as well as voluntarily sign and date an institutional review board (irb) approved informed consent.
boolean
C0525058 (UMLS CUI [1])
C0021430 (UMLS CUI [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 | Therapeutic procedure Hepatitis C virus | PEGINTERFERON | Ribavirin | Antiviral Agents Investigational Hepatitis C virus | Antiviral Agents Hepatitis C virus | Protease Inhibitors | Other Coding | Hepatitis C Virus NS5A Inhibitor
Item
4. current enrollment in another interventional clinical study. previous use of any hcv treatments including pegylated interferon (pegifn), ribavirin, or any direct acting antiviral agent, either investigational or approved, for hcv including protease inhibitors, nucleoside or non-nucleoside polymerase inhibitors, or ns5a inhibitors.
boolean
C2348568 (UMLS CUI [1])
C3274035 (UMLS CUI [2])
C0087111 (UMLS CUI [3,1])
C0220847 (UMLS CUI [3,2])
C0982327 (UMLS CUI [4])
C0035525 (UMLS CUI [5])
C0003451 (UMLS CUI [6,1])
C1517586 (UMLS CUI [6,2])
C0220847 (UMLS CUI [6,3])
C0003451 (UMLS CUI [7,1])
C0220847 (UMLS CUI [7,2])
C0033607 (UMLS CUI [8])
C3846158 (UMLS CUI [9])
C3883357 (UMLS CUI [10])
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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