ID

35256

Description

A Study to Evaluate the Safety and Antiviral Effect of ABT-450/Ritonavir and ABT-530 Coadministered With and Without Ribavirin in Adults With Genotype 3 Hepatitis C (HCV) Infection; ODM derived from: https://clinicaltrials.gov/show/NCT02068222

Link

https://clinicaltrials.gov/show/NCT02068222

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 NCT02068222

English

Eligibility Chronic Hepatitis C NCT02068222

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female (of non-child bearing potential) between 18 and 70 years of age with body mass index ≥18 to <38 kg/m2.
Description

Gender | Female infertility | Age | Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0021361
UMLS CUI [3]
C0001779
UMLS CUI [4]
C1305855
chronic hcv genotype 3 infection prior to study enrollment and has never received antiviral treatment for hcv.
Description

Chronic Hepatitis C Genotype | Antiviral Therapy Absent Hepatitis C virus

Data type

boolean

Alias
UMLS CUI [1,1]
C0524910
UMLS CUI [1,2]
C0017431
UMLS CUI [2,1]
C0280274
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0220847
subject has plasma hcv rna level > 10,000 iu/ml at screening.
Description

Plasma Hepatitis C virus RNA assay

Data type

boolean

Alias
UMLS CUI [1,1]
C0032105
UMLS CUI [1,2]
C1272251
sexually active males must be sterile, have male partners only, or agree to use two effective forms of birth control for 7 months after stopping study drug.
Description

Gender Sexually active Infertility | Partner Male | Gender Sexually active Contraceptive methods Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0241028
UMLS CUI [1,3]
C0021359
UMLS CUI [2,1]
C0682323
UMLS CUI [2,2]
C0086582
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0241028
UMLS CUI [3,3]
C0700589
UMLS CUI [3,4]
C1265611
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of severe, life-threatening or other significant sensitivity to any drug.
Description

Drug Allergy Severe | Drug Allergy Life Threatening | Drug Allergy Significant

Data type

boolean

Alias
UMLS CUI [1,1]
C0013182
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0013182
UMLS CUI [2,2]
C2826244
UMLS CUI [3,1]
C0013182
UMLS CUI [3,2]
C0750502
positive test result for hepatitis b surface antigen (hbsag) or anti-human immunodeficiency virus antibody (hiv ab).
Description

Hepatitis B surface antigen positive | HIV antibody positive

Data type

boolean

Alias
UMLS CUI [1]
C0149709
UMLS CUI [2]
C0920548
prior therapy for the treatment of hcv.
Description

Prior Therapy Hepatitis C virus

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0220847
any current or past clinical evidence of cirrhosis.
Description

Liver Cirrhosis | Liver Cirrhosis In the past

Data type

boolean

Alias
UMLS CUI [1]
C0023890
UMLS CUI [2,1]
C0023890
UMLS CUI [2,2]
C1444637
any cause of liver disease other than chronic hcv-infection.
Description

Liver disease Cause Any | Exception Chronic Hepatitis C

Data type

boolean

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0015127
UMLS CUI [1,3]
C1552551
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0524910
hcv genotype co-infection with any other hcv genotype.
Description

HCV coinfection Genotype | Hepatitis C virus genotype Other

Data type

boolean

Alias
UMLS CUI [1,1]
C1698259
UMLS CUI [1,2]
C0017431
UMLS CUI [2,1]
C1148363
UMLS CUI [2,2]
C0205394
use of contraindicated medications within 2 weeks or 10 half-lives of dosing.
Description

Pharmaceutical Preparations Contraindicated

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1444657
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Similar models

Eligibility Chronic Hepatitis C NCT02068222

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Female infertility | Age | Body mass index
Item
male or female (of non-child bearing potential) between 18 and 70 years of age with body mass index ≥18 to <38 kg/m2.
boolean
C0079399 (UMLS CUI [1])
C0021361 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
C1305855 (UMLS CUI [4])
Chronic Hepatitis C Genotype | Antiviral Therapy Absent Hepatitis C virus
Item
chronic hcv genotype 3 infection prior to study enrollment and has never received antiviral treatment for hcv.
boolean
C0524910 (UMLS CUI [1,1])
C0017431 (UMLS CUI [1,2])
C0280274 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0220847 (UMLS CUI [2,3])
Plasma Hepatitis C virus RNA assay
Item
subject has plasma hcv rna level > 10,000 iu/ml at screening.
boolean
C0032105 (UMLS CUI [1,1])
C1272251 (UMLS CUI [1,2])
Gender Sexually active Infertility | Partner Male | Gender Sexually active Contraceptive methods Quantity
Item
sexually active males must be sterile, have male partners only, or agree to use two effective forms of birth control for 7 months after stopping study drug.
boolean
C0079399 (UMLS CUI [1,1])
C0241028 (UMLS CUI [1,2])
C0021359 (UMLS CUI [1,3])
C0682323 (UMLS CUI [2,1])
C0086582 (UMLS CUI [2,2])
C0079399 (UMLS CUI [3,1])
C0241028 (UMLS CUI [3,2])
C0700589 (UMLS CUI [3,3])
C1265611 (UMLS CUI [3,4])
Item Group
C0680251 (UMLS CUI)
Drug Allergy Severe | Drug Allergy Life Threatening | Drug Allergy Significant
Item
history of severe, life-threatening or other significant sensitivity to any drug.
boolean
C0013182 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0013182 (UMLS CUI [2,1])
C2826244 (UMLS CUI [2,2])
C0013182 (UMLS CUI [3,1])
C0750502 (UMLS CUI [3,2])
Hepatitis B surface antigen positive | HIV antibody positive
Item
positive test result for hepatitis b surface antigen (hbsag) or anti-human immunodeficiency virus antibody (hiv ab).
boolean
C0149709 (UMLS CUI [1])
C0920548 (UMLS CUI [2])
Prior Therapy Hepatitis C virus
Item
prior therapy for the treatment of hcv.
boolean
C1514463 (UMLS CUI [1,1])
C0220847 (UMLS CUI [1,2])
Liver Cirrhosis | Liver Cirrhosis In the past
Item
any current or past clinical evidence of cirrhosis.
boolean
C0023890 (UMLS CUI [1])
C0023890 (UMLS CUI [2,1])
C1444637 (UMLS CUI [2,2])
Liver disease Cause Any | Exception Chronic Hepatitis C
Item
any cause of liver disease other than chronic hcv-infection.
boolean
C0023895 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
C1552551 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0524910 (UMLS CUI [2,2])
HCV coinfection Genotype | Hepatitis C virus genotype Other
Item
hcv genotype co-infection with any other hcv genotype.
boolean
C1698259 (UMLS CUI [1,1])
C0017431 (UMLS CUI [1,2])
C1148363 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
Pharmaceutical Preparations Contraindicated
Item
use of contraindicated medications within 2 weeks or 10 half-lives of dosing.
boolean
C0013227 (UMLS CUI [1,1])
C1444657 (UMLS CUI [1,2])
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