ID

44394

Beschreibung

Peginterferon and Ribavirin, With or Without Telaprevir, for Genotype 1 Hepatitis C and IL28B CC Polymorphism; ODM derived from: https://clinicaltrials.gov/show/NCT01415141

Link

https://clinicaltrials.gov/show/NCT01415141

Stichworte

Versionen (2)
  1. 06.02.20 06.02.20 -
  2. 20.09.21 20.09.21 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

20. September 2021

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Hepatitis C NCT01415141

Englisch

Eligibility Hepatitis C NCT01415141

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
age > 18 years
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
serum hepatitis c rna > 10,000iu/ml
Beschreibung

Hepatitis C virus RNA assay

Datentyp

boolean

Alias
UMLS CUI [1]
C1272251
hepatitis c virus genotype 1
Beschreibung

Hepatitis C virus genotype determination

Datentyp

boolean

Alias
UMLS CUI [1]
C1533728
il28b polymorphism
Beschreibung

IL-28B polymorphism

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1425475
UMLS CUI [1,2]
C0032529
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous treatment for chronic hepatitis c
Beschreibung

Prior Therapy Chronic Hepatitis C

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0524910
clinical or biological evidence of acute hepatitis, including serum alt or ast > 300u/ml
Beschreibung

Hepatitis | Alanine aminotransferase measurement | Aspartate aminotransferase measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0019158
UMLS CUI [2]
C0201836
UMLS CUI [3]
C0201899
hiv antibody positive, hepatitis b surface antigen positive or known diagnosis of other chronic liver disease
Beschreibung

HIV antibody positive | Hepatitis B surface antigen positive | Chronic liver disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0920548
UMLS CUI [2]
C0149709
UMLS CUI [3]
C0341439
contraindications to pr-based treatment:
Beschreibung

Medical contraindication PEGINTERFERON/RIBAVIRIN Therapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C1875630
UMLS CUI [1,3]
C0087111
1. uncontrolled psychiatric illness
Beschreibung

Mental disorder Uncontrolled

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0205318
2. active substance dependency
Beschreibung

Substance Dependence

Datentyp

boolean

Alias
UMLS CUI [1]
C0038580
3. known autoimmune disorder
Beschreibung

Autoimmune Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0004364
4. untreated thyroid disease
Beschreibung

Thyroid Disease Untreated

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0040128
UMLS CUI [1,2]
C0332155
5. uncontrolled seizure disorder
Beschreibung

Seizure Uncontrolled

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0036572
UMLS CUI [1,2]
C0205318
6. pregnancy, lactation or inability to maintain contraception
Beschreibung

Pregnancy | Breast Feeding | Contraceptive methods Maintain Unable

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0700589
UMLS CUI [3,2]
C0024501
UMLS CUI [3,3]
C1299582
7. chronic kidney disease w/ estimated gfr< 60
Beschreibung

Chronic Kidney Disease | Estimated Glomerular Filtration Rate

Datentyp

boolean

Alias
UMLS CUI [1]
C1561643
UMLS CUI [2]
C3811844
8. anc<1.5/nl, hb<12g/dl, or platelets<75/nl
Beschreibung

Absolute neutrophil count | Hemoglobin measurement | Platelet Count measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2]
C0518015
UMLS CUI [3]
C0032181
clinical or biochemical evidence of decompensated liver disease including:
Beschreibung

Decompensated liver disease

Datentyp

boolean

Alias
UMLS CUI [1]
C4075847
1. history of encephalopathy, ascites, or variceal bleeding or
Beschreibung

Encephalopathy | Ascites | Bleeding varices

Datentyp

boolean

Alias
UMLS CUI [1]
C0085584
UMLS CUI [2]
C0003962
UMLS CUI [3]
C0333106
2. bilirubin > 3g/dl or inr > 1.5
Beschreibung

Serum total bilirubin measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C1278039
life threatening disorder with expected median survival less than 5 years
Beschreibung

Life threatening illness | Median Survival Time Expected

Datentyp

boolean

Alias
UMLS CUI [1]
C3846017
UMLS CUI [2,1]
C2986586
UMLS CUI [2,2]
C1517001
inability to comply with drug regimens or testing schedule required for study
Beschreibung

Compliance behavior Unable Pharmacotherapy | Compliance behavior Unable Testing

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C1299582
UMLS CUI [1,3]
C0013216
UMLS CUI [2,1]
C1321605
UMLS CUI [2,2]
C1299582
UMLS CUI [2,3]
C0039593
lack of insurance coverage for any of the study medications
Beschreibung

Lacking Insurance Coverage Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C0376629
UMLS CUI [1,3]
C0013230
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Ähnliche Modelle

Eligibility Hepatitis C NCT01415141

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age > 18 years
boolean
C0001779 (UMLS CUI [1])
Hepatitis C virus RNA assay
Item
serum hepatitis c rna > 10,000iu/ml
boolean
C1272251 (UMLS CUI [1])
Hepatitis C virus genotype determination
Item
hepatitis c virus genotype 1
boolean
C1533728 (UMLS CUI [1])
IL-28B polymorphism
Item
il28b polymorphism
boolean
C1425475 (UMLS CUI [1,1])
C0032529 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Prior Therapy Chronic Hepatitis C
Item
previous treatment for chronic hepatitis c
boolean
C1514463 (UMLS CUI [1,1])
C0524910 (UMLS CUI [1,2])
Hepatitis | Alanine aminotransferase measurement | Aspartate aminotransferase measurement
Item
clinical or biological evidence of acute hepatitis, including serum alt or ast > 300u/ml
boolean
C0019158 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
HIV antibody positive | Hepatitis B surface antigen positive | Chronic liver disease
Item
hiv antibody positive, hepatitis b surface antigen positive or known diagnosis of other chronic liver disease
boolean
C0920548 (UMLS CUI [1])
C0149709 (UMLS CUI [2])
C0341439 (UMLS CUI [3])
Medical contraindication PEGINTERFERON/RIBAVIRIN Therapy
Item
contraindications to pr-based treatment:
boolean
C1301624 (UMLS CUI [1,1])
C1875630 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
Mental disorder Uncontrolled
Item
1. uncontrolled psychiatric illness
boolean
C0004936 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Substance Dependence
Item
2. active substance dependency
boolean
C0038580 (UMLS CUI [1])
Autoimmune Disease
Item
3. known autoimmune disorder
boolean
C0004364 (UMLS CUI [1])
Thyroid Disease Untreated
Item
4. untreated thyroid disease
boolean
C0040128 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
Seizure Uncontrolled
Item
5. uncontrolled seizure disorder
boolean
C0036572 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Pregnancy | Breast Feeding | Contraceptive methods Maintain Unable
Item
6. pregnancy, lactation or inability to maintain contraception
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0700589 (UMLS CUI [3,1])
C0024501 (UMLS CUI [3,2])
C1299582 (UMLS CUI [3,3])
Chronic Kidney Disease | Estimated Glomerular Filtration Rate
Item
7. chronic kidney disease w/ estimated gfr< 60
boolean
C1561643 (UMLS CUI [1])
C3811844 (UMLS CUI [2])
Absolute neutrophil count | Hemoglobin measurement | Platelet Count measurement
Item
8. anc<1.5/nl, hb<12g/dl, or platelets<75/nl
boolean
C0948762 (UMLS CUI [1])
C0518015 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
Decompensated liver disease
Item
clinical or biochemical evidence of decompensated liver disease including:
boolean
C4075847 (UMLS CUI [1])
Encephalopathy | Ascites | Bleeding varices
Item
1. history of encephalopathy, ascites, or variceal bleeding or
boolean
C0085584 (UMLS CUI [1])
C0003962 (UMLS CUI [2])
C0333106 (UMLS CUI [3])
Serum total bilirubin measurement
Item
2. bilirubin > 3g/dl or inr > 1.5
boolean
C1278039 (UMLS CUI [1])
Life threatening illness | Median Survival Time Expected
Item
life threatening disorder with expected median survival less than 5 years
boolean
C3846017 (UMLS CUI [1])
C2986586 (UMLS CUI [2,1])
C1517001 (UMLS CUI [2,2])
Compliance behavior Unable Pharmacotherapy | Compliance behavior Unable Testing
Item
inability to comply with drug regimens or testing schedule required for study
boolean
C1321605 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0013216 (UMLS CUI [1,3])
C1321605 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
C0039593 (UMLS CUI [2,3])
Lacking Insurance Coverage Investigational New Drugs
Item
lack of insurance coverage for any of the study medications
boolean
C0332268 (UMLS CUI [1,1])
C0376629 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,3])
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