ID

29709

Beschreibung

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

Stichworte

Versionen (2)
  1. 14.04.18 14.04.18 -
  2. 20.09.21 20.09.21 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

14. April 2018

DOI

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Creative Commons BY 4.0
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Eligibility Hepatitis C NCT00752687

Englisch

Eligibility Hepatitis C NCT00752687

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
criteria for healthy adults:
Beschreibung

Criteria Healthy adult

Datentyp

boolean

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

Informed Consent

Datentyp

boolean

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

General health good

Datentyp

boolean

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

Postmenopausal state

Datentyp

boolean

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

Pregnancy Absent

Datentyp

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
Beschreibung

Gender Contraceptive methods | Male sterilization | Partner Contraceptive methods

Datentyp

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
Beschreibung

Body mass index

Datentyp

boolean

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

Criteria Adult Hepatitis C

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

Hepatitis C HCV genotype determination | Hepatitis C virus RNA Detectable

Datentyp

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
criteria for healthy adults:
Beschreibung

Criteria Healthy adult

Datentyp

boolean

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

Pregnancy | Breast Feeding

Datentyp

boolean

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

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

Datentyp

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
Beschreibung

Substance Use Disorders | Nicotine product Use of

Datentyp

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
Beschreibung

Alcohol consumption

Datentyp

boolean

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

Criteria Adult Hepatitis C

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

Child-Pugh Classification | Liver Cirrhosis

Datentyp

boolean

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

Cause Liver disease | Exception Hepatitis C

Datentyp

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
Beschreibung

Alanine aminotransferase increased | Aspartate aminotransferase increased

Datentyp

boolean

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

Serum creatinine raised

Datentyp

boolean

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

Electrocardiogram abnormal

Datentyp

boolean

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

Hepatitis C RNA increased

Datentyp

boolean

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

Thyroid stimulating hormone measurement Abnormal

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0202230
UMLS CUI [1,2]
C0205161
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Ähnliche Modelle

Eligibility Hepatitis C NCT00752687

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
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