ID

29709

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT00752687

Nyckelord

Versioner (2)
  1. 2018-04-14 2018-04-14 -
  2. 2021-09-20 2021-09-20 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

14 april 2018

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Eligibility Hepatitis C NCT00752687

Engelsk

Eligibility Hepatitis C NCT00752687

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
criteria for healthy adults:
Beskrivning

Criteria Healthy adult

Datatyp

boolean

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

Informed Consent

Datatyp

boolean

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

General health good

Datatyp

boolean

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

Postmenopausal state

Datatyp

boolean

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

Pregnancy Absent

Datatyp

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
Beskrivning

Gender Contraceptive methods | Male sterilization | Partner Contraceptive methods

Datatyp

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
Beskrivning

Body mass index

Datatyp

boolean

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

Criteria Adult Hepatitis C

Datatyp

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
Beskrivning

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

Datatyp

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
Beskrivning

Hepatitis C HCV genotype determination | Hepatitis C virus RNA Detectable

Datatyp

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
criteria for healthy adults:
Beskrivning

Criteria Healthy adult

Datatyp

boolean

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

Pregnancy | Breast Feeding

Datatyp

boolean

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

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

Datatyp

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
Beskrivning

Substance Use Disorders | Nicotine product Use of

Datatyp

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
Beskrivning

Alcohol consumption

Datatyp

boolean

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

Criteria Adult Hepatitis C

Datatyp

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
Beskrivning

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

Datatyp

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
Beskrivning

Child-Pugh Classification | Liver Cirrhosis

Datatyp

boolean

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

Cause Liver disease | Exception Hepatitis C

Datatyp

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
Beskrivning

Alanine aminotransferase increased | Aspartate aminotransferase increased

Datatyp

boolean

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

Serum creatinine raised

Datatyp

boolean

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

Electrocardiogram abnormal

Datatyp

boolean

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

Hepatitis C RNA increased

Datatyp

boolean

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

Thyroid stimulating hormone measurement Abnormal

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0202230
UMLS CUI [1,2]
C0205161
Tillbaka till toppen

Similar models

Eligibility Hepatitis C NCT00752687

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

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