ID

29709

Description

A Study of ABT-072 in Healthy and Hepatitis C Virus Genotype 1-Infected Adults; ODM derived from: https://clinicaltrials.gov/show/NCT00752687

Link

https://clinicaltrials.gov/show/NCT00752687

Keywords

Versions (2)
  1. 4/14/18 4/14/18 -
  2. 9/20/21 9/20/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 14, 2018

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Hepatitis C NCT00752687

English

Eligibility Hepatitis C NCT00752687

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
criteria for healthy adults:
Description

Criteria Healthy adult

Data type

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C0686750
informed consent has been obtained
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
subject is in general good health
Description

General health good

Data type

boolean

Alias
UMLS CUI [1]
C1277245
if female, then postmenopausal
Description

Postmenopausal state

Data type

boolean

Alias
UMLS CUI [1]
C0232970
if female, then not pregnant
Description

Pregnancy Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0332197
if male, must be surgically sterile or both he and the partner must use birth control
Description

Gender Contraceptive methods | Male sterilization | Partner Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0700589
UMLS CUI [2]
C0024559
UMLS CUI [3,1]
C0682323
UMLS CUI [3,2]
C0700589
body mass index is 18 to 29, inclusive
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
criteria for hcv-infected adults:
Description

Criteria Adult Hepatitis C

Data type

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C0001675
UMLS CUI [1,3]
C0019196
infected with hcv for at least 6 months as shown by either detectable hcv rna or reactive antibody, or liver biopsy with pathology indicative of hcv infection, or disclosure of a risk factor
Description

Hepatitis C Disease length | Hepatitis C virus RNA Detectable | Hepatitis C Antibodies Reactive | Hepatitis C Biopsy of liver | Disclosure Risk factors

Data type

boolean

Alias
UMLS CUI [1,1]
C0019196
UMLS CUI [1,2]
C0872146
UMLS CUI [2,1]
C0369335
UMLS CUI [2,2]
C3830527
UMLS CUI [3,1]
C0166049
UMLS CUI [3,2]
C0205332
UMLS CUI [4,1]
C0019196
UMLS CUI [4,2]
C0193388
UMLS CUI [5,1]
C0012625
UMLS CUI [5,2]
C0035648
subject is infected with hcv genotype 1 with detectable hcv rna of > 50,000 iu/ml
Description

Hepatitis C HCV genotype determination | Hepatitis C virus RNA Detectable

Data type

boolean

Alias
UMLS CUI [1,1]
C0019196
UMLS CUI [1,2]
C1533728
UMLS CUI [2,1]
C0369335
UMLS CUI [2,2]
C3830527
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
criteria for healthy adults:
Description

Criteria Healthy adult

Data type

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C0686750
if female, then pregnant or breast feeding
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
positive hav-igm, hbs-ag, hcv ab or hiv ab
Description

Hepatitis A IgM Positive | Hepatitis B surface antigen positive | Hepatitis C antibody positive | HIV antibody positive

Data type

boolean

Alias
UMLS CUI [1,1]
C0856422
UMLS CUI [1,2]
C1514241
UMLS CUI [2]
C0149709
UMLS CUI [3]
C0281863
UMLS CUI [4]
C0920548
within 6 months of start of study, drug or alcohol abuse and use of nicotine products
Description

Substance Use Disorders | Nicotine product Use of

Data type

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2,1]
C0028040
UMLS CUI [2,2]
C1514468
UMLS CUI [2,3]
C1524063
alcohol intake within 48 hours prior to study drug administration
Description

Alcohol consumption

Data type

boolean

Alias
UMLS CUI [1]
C0001948
criteria for hcv-infected adults:
Description

Criteria Adult Hepatitis C

Data type

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C0001675
UMLS CUI [1,3]
C0019196
need for prescription or over-the-counter medication
Description

Patient need for Drug Prescription | Patient need for Non-Prescription Drugs

Data type

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C0033081
UMLS CUI [2,1]
C0686904
UMLS CUI [2,2]
C0013231
child pugh score > 5 or clinical evidence of cirrhosis
Description

Child-Pugh Classification | Liver Cirrhosis

Data type

boolean

Alias
UMLS CUI [1]
C2347612
UMLS CUI [2]
C0023890
no other cause for liver disease other than hcv infection
Description

Cause Liver disease | Exception Hepatitis C

Data type

boolean

Alias
UMLS CUI [1,1]
C0015127
UMLS CUI [1,2]
C0023895
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0019196
alt or ast > 4 x uln
Description

Alanine aminotransferase increased | Aspartate aminotransferase increased

Data type

boolean

Alias
UMLS CUI [1]
C0151905
UMLS CUI [2]
C0151904
creatinine > uln
Description

Serum creatinine raised

Data type

boolean

Alias
UMLS CUI [1]
C0700225
clinically significant abnormal ecg
Description

Electrocardiogram abnormal

Data type

boolean

Alias
UMLS CUI [1]
C0522055
hcv rna levels above the level of assay quantification
Description

Hepatitis C RNA increased

Data type

boolean

Alias
UMLS CUI [1]
C2363762
tsh values outside normal range
Description

Thyroid stimulating hormone measurement Abnormal

Data type

boolean

Alias
UMLS CUI [1,1]
C0202230
UMLS CUI [1,2]
C0205161
Back to the top of the page

Similar models

Eligibility Hepatitis C NCT00752687

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Criteria Healthy adult
Item
criteria for healthy adults:
boolean
C0243161 (UMLS CUI [1,1])
C0686750 (UMLS CUI [1,2])
Informed Consent
Item
informed consent has been obtained
boolean
C0021430 (UMLS CUI [1])
General health good
Item
subject is in general good health
boolean
C1277245 (UMLS CUI [1])
Postmenopausal state
Item
if female, then postmenopausal
boolean
C0232970 (UMLS CUI [1])
Pregnancy Absent
Item
if female, then not pregnant
boolean
C0032961 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Gender Contraceptive methods | Male sterilization | Partner Contraceptive methods
Item
if male, must be surgically sterile or both he and the partner must use birth control
boolean
C0079399 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0024559 (UMLS CUI [2])
C0682323 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
Body mass index
Item
body mass index is 18 to 29, inclusive
boolean
C1305855 (UMLS CUI [1])
Criteria Adult Hepatitis C
Item
criteria for hcv-infected adults:
boolean
C0243161 (UMLS CUI [1,1])
C0001675 (UMLS CUI [1,2])
C0019196 (UMLS CUI [1,3])
Hepatitis C Disease length | Hepatitis C virus RNA Detectable | Hepatitis C Antibodies Reactive | Hepatitis C Biopsy of liver | Disclosure Risk factors
Item
infected with hcv for at least 6 months as shown by either detectable hcv rna or reactive antibody, or liver biopsy with pathology indicative of hcv infection, or disclosure of a risk factor
boolean
C0019196 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C0369335 (UMLS CUI [2,1])
C3830527 (UMLS CUI [2,2])
C0166049 (UMLS CUI [3,1])
C0205332 (UMLS CUI [3,2])
C0019196 (UMLS CUI [4,1])
C0193388 (UMLS CUI [4,2])
C0012625 (UMLS CUI [5,1])
C0035648 (UMLS CUI [5,2])
Hepatitis C HCV genotype determination | Hepatitis C virus RNA Detectable
Item
subject is infected with hcv genotype 1 with detectable hcv rna of > 50,000 iu/ml
boolean
C0019196 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
C0369335 (UMLS CUI [2,1])
C3830527 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Criteria Healthy adult
Item
criteria for healthy adults:
boolean
C0243161 (UMLS CUI [1,1])
C0686750 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
if female, then pregnant or breast feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Hepatitis A IgM Positive | Hepatitis B surface antigen positive | Hepatitis C antibody positive | HIV antibody positive
Item
positive hav-igm, hbs-ag, hcv ab or hiv ab
boolean
C0856422 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
C0149709 (UMLS CUI [2])
C0281863 (UMLS CUI [3])
C0920548 (UMLS CUI [4])
Substance Use Disorders | Nicotine product Use of
Item
within 6 months of start of study, drug or alcohol abuse and use of nicotine products
boolean
C0038586 (UMLS CUI [1])
C0028040 (UMLS CUI [2,1])
C1514468 (UMLS CUI [2,2])
C1524063 (UMLS CUI [2,3])
Alcohol consumption
Item
alcohol intake within 48 hours prior to study drug administration
boolean
C0001948 (UMLS CUI [1])
Criteria Adult Hepatitis C
Item
criteria for hcv-infected adults:
boolean
C0243161 (UMLS CUI [1,1])
C0001675 (UMLS CUI [1,2])
C0019196 (UMLS CUI [1,3])
Patient need for Drug Prescription | Patient need for Non-Prescription Drugs
Item
need for prescription or over-the-counter medication
boolean
C0686904 (UMLS CUI [1,1])
C0033081 (UMLS CUI [1,2])
C0686904 (UMLS CUI [2,1])
C0013231 (UMLS CUI [2,2])
Child-Pugh Classification | Liver Cirrhosis
Item
child pugh score > 5 or clinical evidence of cirrhosis
boolean
C2347612 (UMLS CUI [1])
C0023890 (UMLS CUI [2])
Cause Liver disease | Exception Hepatitis C
Item
no other cause for liver disease other than hcv infection
boolean
C0015127 (UMLS CUI [1,1])
C0023895 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0019196 (UMLS CUI [2,2])
Alanine aminotransferase increased | Aspartate aminotransferase increased
Item
alt or ast > 4 x uln
boolean
C0151905 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
Serum creatinine raised
Item
creatinine > uln
boolean
C0700225 (UMLS CUI [1])
Electrocardiogram abnormal
Item
clinically significant abnormal ecg
boolean
C0522055 (UMLS CUI [1])
Hepatitis C RNA increased
Item
hcv rna levels above the level of assay quantification
boolean
C2363762 (UMLS CUI [1])
Thyroid stimulating hormone measurement Abnormal
Item
tsh values outside normal range
boolean
C0202230 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial