ID

39583

Description

A Randomized Study to Evaluate the Safety, Tolerability and Antiviral Activity of ABT-450, ABT-333 and ABT-072; ODM derived from: https://clinicaltrials.gov/show/NCT01074008

Link

https://clinicaltrials.gov/show/NCT01074008

Keywords

Versions (1)
  1. 1/31/20 1/31/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

January 31, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatitis C NCT01074008

English

Eligibility Hepatitis C NCT01074008

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
chronic hepatitis c virus (hcv), genotype 1 infection (hcv ribonucleic acid level greater than or equal to 100,000 iu/ml) at screening
Description

Chronic Hepatitis C Genotype | Hepatitis C virus RNA assay

Data type

boolean

Alias
UMLS CUI [1,1]
C0524910
UMLS CUI [1,2]
C1533728
UMLS CUI [2]
C1272251
liver biopsy within 3 years with histology consistent with hcv-induced liver damage, with no evidence of cirrhosis or liver pathology due to any cause other than chronic hcv
Description

Biopsy of liver | Liver damage HCV Induced | Liver Cirrhosis Absent

Data type

boolean

Alias
UMLS CUI [1]
C0193388
UMLS CUI [2,1]
C0151763
UMLS CUI [2,2]
C0220847
UMLS CUI [2,3]
C0205263
UMLS CUI [3,1]
C0023890
UMLS CUI [3,2]
C0332197
treatment naïve male or female between the ages of 18 and 65
Description

Therapy naive | Age

Data type

boolean

Alias
UMLS CUI [1]
C0919936
UMLS CUI [2]
C0001779
females must be post-menopausal for more than 2 years or surgically sterile
Description

Postmenopausal state Duration | Female Sterilization

Data type

boolean

Alias
UMLS CUI [1,1]
C0232970
UMLS CUI [1,2]
C0449238
UMLS CUI [2]
C0015787
negative screen for drugs and alcohol
Description

Drug screen negative | Screening for alcohol abuse Negative

Data type

boolean

Alias
UMLS CUI [1]
C0919819
UMLS CUI [2,1]
C4032438
UMLS CUI [2,2]
C1513916
negative hepatitis b surface antigen (hbsag) and anti-human immunodeficiency virus antibodies (anti-hiv ab)
Description

Hepatitis B surface antigen negative | HIV antibody negative

Data type

boolean

Alias
UMLS CUI [1]
C0919711
UMLS CUI [2]
C1142096
no use of cytochrome p450 3a (cyp3a) and cytochrome p450 2c8 (cyp2c8) enzyme inducers or inhibitors within 1 month of dosing
Description

CYP3A Inducers Absent | CYP3A Inhibitors Absent | CYP2C8 Inducers Absent | CYP2C8 Inhibitors Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C3850044
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C3850056
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C3850048
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C3850061
UMLS CUI [4,2]
C0332197
be in a condition of general good health, as perceived by the investigator, other than hcv infection
Description

General health good | Exception Hepatitis C

Data type

boolean

Alias
UMLS CUI [1]
C1277245
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0019196
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
significant sensitivity to any drug
Description

Drug Allergy

Data type

boolean

Alias
UMLS CUI [1]
C0013182
use of herbal supplements within 2 weeks prior to study drug dosing
Description

Herbal Supplements

Data type

boolean

Alias
UMLS CUI [1]
C1504473
history of major depression within 2 years
Description

Major Depressive Disorder

Data type

boolean

Alias
UMLS CUI [1]
C1269683
prior treatment with any investigational or commercially available anti-hcv agents
Description

Anti-hepatitis C (HCV) Agents

Data type

boolean

Alias
UMLS CUI [1]
C4324240
abnormal laboratory tests
Description

Laboratory test result abnormal

Data type

boolean

Alias
UMLS CUI [1]
C0438215
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Similar models

Eligibility Hepatitis C NCT01074008

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Chronic Hepatitis C Genotype | Hepatitis C virus RNA assay
Item
chronic hepatitis c virus (hcv), genotype 1 infection (hcv ribonucleic acid level greater than or equal to 100,000 iu/ml) at screening
boolean
C0524910 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
C1272251 (UMLS CUI [2])
Biopsy of liver | Liver damage HCV Induced | Liver Cirrhosis Absent
Item
liver biopsy within 3 years with histology consistent with hcv-induced liver damage, with no evidence of cirrhosis or liver pathology due to any cause other than chronic hcv
boolean
C0193388 (UMLS CUI [1])
C0151763 (UMLS CUI [2,1])
C0220847 (UMLS CUI [2,2])
C0205263 (UMLS CUI [2,3])
C0023890 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Therapy naive | Age
Item
treatment naïve male or female between the ages of 18 and 65
boolean
C0919936 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Postmenopausal state Duration | Female Sterilization
Item
females must be post-menopausal for more than 2 years or surgically sterile
boolean
C0232970 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0015787 (UMLS CUI [2])
Drug screen negative | Screening for alcohol abuse Negative
Item
negative screen for drugs and alcohol
boolean
C0919819 (UMLS CUI [1])
C4032438 (UMLS CUI [2,1])
C1513916 (UMLS CUI [2,2])
Hepatitis B surface antigen negative | HIV antibody negative
Item
negative hepatitis b surface antigen (hbsag) and anti-human immunodeficiency virus antibodies (anti-hiv ab)
boolean
C0919711 (UMLS CUI [1])
C1142096 (UMLS CUI [2])
CYP3A Inducers Absent | CYP3A Inhibitors Absent | CYP2C8 Inducers Absent | CYP2C8 Inhibitors Absent
Item
no use of cytochrome p450 3a (cyp3a) and cytochrome p450 2c8 (cyp2c8) enzyme inducers or inhibitors within 1 month of dosing
boolean
C3850044 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C3850056 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C3850048 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C3850061 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
General health good | Exception Hepatitis C
Item
be in a condition of general good health, as perceived by the investigator, other than hcv infection
boolean
C1277245 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0019196 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Drug Allergy
Item
significant sensitivity to any drug
boolean
C0013182 (UMLS CUI [1])
Herbal Supplements
Item
use of herbal supplements within 2 weeks prior to study drug dosing
boolean
C1504473 (UMLS CUI [1])
Major Depressive Disorder
Item
history of major depression within 2 years
boolean
C1269683 (UMLS CUI [1])
Anti-hepatitis C (HCV) Agents
Item
prior treatment with any investigational or commercially available anti-hcv agents
boolean
C4324240 (UMLS CUI [1])
Laboratory test result abnormal
Item
abnormal laboratory tests
boolean
C0438215 (UMLS CUI [1])
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