ID

29695

Beskrivning

Infergen and Ribavirin Treatment of Patients With HCV Who Achieved Partial Response to Peginterferon-alfa and Ribavirin; ODM derived from: https://clinicaltrials.gov/show/NCT00456248

Länk

https://clinicaltrials.gov/show/NCT00456248

Nyckelord

Versioner (1)
  1. 2018-04-13 2018-04-13 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

13 april 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Hepatitis C NCT00456248

Engelsk

Eligibility Hepatitis C NCT00456248

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female, at least 18 years of age and no older than 65 years with compensated chronic hcv infection based on a history of positive serum anti-hcv antibody and/or hcv rna
Beskrivning

Age | Chronic Hepatitis C Compensated | Hepatitis C antibody positive | Hepatitis C RNA positive

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0524910
UMLS CUI [2,2]
C0205432
UMLS CUI [3]
C0281863
UMLS CUI [4]
C0855842
diagnosed with hcv genotype 1, 4, 5 or 6 as determined during the screening visit
Beskrivning

Hepatitis C virus genotype determination

Datatyp

boolean

Alias
UMLS CUI [1]
C1533728
the starting doses in the initial treatment must have been 1.5 μg/kg/week peg-intron or 180 μg/week pegasys, and 1000/1200 mg/day ribavirin based on body weight. patients must have been at least 80% compliant during the initial peginterferon/ribavirin therapy, per patient account.
Beskrivning

Pegintron Dose | Pegasys Dose | Ribavirin Dose | Body Weight | Patient need for Compliance behavior Percentage | PEGINTERFERON/RIBAVIRIN

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1527737
UMLS CUI [1,2]
C0178602
UMLS CUI [2,1]
C1176430
UMLS CUI [2,2]
C0178602
UMLS CUI [3,1]
C0035525
UMLS CUI [3,2]
C0178602
UMLS CUI [4]
C0005910
UMLS CUI [5,1]
C0686904
UMLS CUI [5,2]
C1321605
UMLS CUI [5,3]
C0439165
UMLS CUI [6]
C1875630
liver biopsy indicating f0-f4 must be performed within 3 years prior to screening. documentation of the results of the biopsy must be available. if documentation is not available, a liver biopsy must be performed during the screening period. (a maximum of 10 patients in each of the three treatment groups will be patients with a fibrosis score of f4)
Beskrivning

Biopsy of liver Fibrosis score

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0193388
UMLS CUI [1,2]
C1954437
documented partial response after 12 weeks of treatment as a therapy-naive patient with one course of peginterferon alfa-2a (pegasys) and ribavirin or peginterferon alfa-2b (peg-intron) and ribavirin
Beskrivning

Partial response | Therapeutic procedure Patient Therapy naive | Peginterferon alfa-2a Course Quantity | Pegasys Course Quantity | Peginterferon alfa-2b Course Quantity | Pegintron Course Quantity | Ribavirin Course Quantity

Datatyp

boolean

Alias
UMLS CUI [1]
C1521726
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0030705
UMLS CUI [2,3]
C0919936
UMLS CUI [3,1]
C0391001
UMLS CUI [3,2]
C0750729
UMLS CUI [3,3]
C1265611
UMLS CUI [4,1]
C1176430
UMLS CUI [4,2]
C0750729
UMLS CUI [4,3]
C1265611
UMLS CUI [5,1]
C0796545
UMLS CUI [5,2]
C0750729
UMLS CUI [5,3]
C1265611
UMLS CUI [6,1]
C1527737
UMLS CUI [6,2]
C0750729
UMLS CUI [6,3]
C1265611
UMLS CUI [7,1]
C0035525
UMLS CUI [7,2]
C0750729
UMLS CUI [7,3]
C1265611
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
detectable hcv rna after 12 weeks if initial peginterferon alfa/ribavirin therapy and <2 log decrease in hcv rna at week 12 from baseline.
Beskrivning

Hepatitis C virus RNA Detectable | peginterferon alfa-2a | peginterferon alfa-2b | Ribavirin | Hepatitis C RNA decreased

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0369335
UMLS CUI [1,2]
C3830527
UMLS CUI [2]
C0391001
UMLS CUI [3]
C0796545
UMLS CUI [4]
C0035525
UMLS CUI [5]
C2363763
hcv genotype 2 or 3
Beskrivning

Hepatitis C virus genotype determination

Datatyp

boolean

Alias
UMLS CUI [1]
C1533728
severe neuropsychiatric disorder.
Beskrivning

Neuropsychiatric syndrome Severe

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3203509
UMLS CUI [1,2]
C0205082
history or clinical manifestations of significant metabolic, hematological, pulmonary, ischemic heart disease, significant or unstable heart disease, gastrointestinal, neurological, renal, urological, endocrine, ophthalmologic disorders including severe retinopathy, or immune-mediated disease.
Beskrivning

Metabolic Disease | Hematological Disease | Lung disease | Myocardial Ischemia | Heart Disease | Heart Disease Unstable | Gastrointestinal Diseases | Nervous system disorder | Kidney Diseases | Urologic Diseases | Endocrine System Diseases | Disorder of eye | Retinal Diseases Severe | Immune System Diseases

Datatyp

boolean

Alias
UMLS CUI [1]
C0025517
UMLS CUI [2]
C0018939
UMLS CUI [3]
C0024115
UMLS CUI [4]
C0151744
UMLS CUI [5]
C0018799
UMLS CUI [6,1]
C0018799
UMLS CUI [6,2]
C0443343
UMLS CUI [7]
C0017178
UMLS CUI [8]
C0027765
UMLS CUI [9]
C0022658
UMLS CUI [10]
C0042075
UMLS CUI [11]
C0014130
UMLS CUI [12]
C0015397
UMLS CUI [13,1]
C0035309
UMLS CUI [13,2]
C0205082
UMLS CUI [14]
C0021053
known hiv infection or positive hiv at screening.
Beskrivning

HIV Infection | HIV Seropositivity

Datatyp

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C0019699
pregnant or breast-feeding patients.
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
underlying autoimmune disease
Beskrivning

Autoimmune Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0004364
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Similar models

Eligibility Hepatitis C NCT00456248

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age | Chronic Hepatitis C Compensated | Hepatitis C antibody positive | Hepatitis C RNA positive
Item
male or female, at least 18 years of age and no older than 65 years with compensated chronic hcv infection based on a history of positive serum anti-hcv antibody and/or hcv rna
boolean
C0001779 (UMLS CUI [1])
C0524910 (UMLS CUI [2,1])
C0205432 (UMLS CUI [2,2])
C0281863 (UMLS CUI [3])
C0855842 (UMLS CUI [4])
Hepatitis C virus genotype determination
Item
diagnosed with hcv genotype 1, 4, 5 or 6 as determined during the screening visit
boolean
C1533728 (UMLS CUI [1])
Pegintron Dose | Pegasys Dose | Ribavirin Dose | Body Weight | Patient need for Compliance behavior Percentage | PEGINTERFERON/RIBAVIRIN
Item
the starting doses in the initial treatment must have been 1.5 μg/kg/week peg-intron or 180 μg/week pegasys, and 1000/1200 mg/day ribavirin based on body weight. patients must have been at least 80% compliant during the initial peginterferon/ribavirin therapy, per patient account.
boolean
C1527737 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1176430 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0035525 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0005910 (UMLS CUI [4])
C0686904 (UMLS CUI [5,1])
C1321605 (UMLS CUI [5,2])
C0439165 (UMLS CUI [5,3])
C1875630 (UMLS CUI [6])
Biopsy of liver Fibrosis score
Item
liver biopsy indicating f0-f4 must be performed within 3 years prior to screening. documentation of the results of the biopsy must be available. if documentation is not available, a liver biopsy must be performed during the screening period. (a maximum of 10 patients in each of the three treatment groups will be patients with a fibrosis score of f4)
boolean
C0193388 (UMLS CUI [1,1])
C1954437 (UMLS CUI [1,2])
Partial response | Therapeutic procedure Patient Therapy naive | Peginterferon alfa-2a Course Quantity | Pegasys Course Quantity | Peginterferon alfa-2b Course Quantity | Pegintron Course Quantity | Ribavirin Course Quantity
Item
documented partial response after 12 weeks of treatment as a therapy-naive patient with one course of peginterferon alfa-2a (pegasys) and ribavirin or peginterferon alfa-2b (peg-intron) and ribavirin
boolean
C1521726 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0030705 (UMLS CUI [2,2])
C0919936 (UMLS CUI [2,3])
C0391001 (UMLS CUI [3,1])
C0750729 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
C1176430 (UMLS CUI [4,1])
C0750729 (UMLS CUI [4,2])
C1265611 (UMLS CUI [4,3])
C0796545 (UMLS CUI [5,1])
C0750729 (UMLS CUI [5,2])
C1265611 (UMLS CUI [5,3])
C1527737 (UMLS CUI [6,1])
C0750729 (UMLS CUI [6,2])
C1265611 (UMLS CUI [6,3])
C0035525 (UMLS CUI [7,1])
C0750729 (UMLS CUI [7,2])
C1265611 (UMLS CUI [7,3])
Item Group
C0680251 (UMLS CUI)
Hepatitis C virus RNA Detectable | peginterferon alfa-2a | peginterferon alfa-2b | Ribavirin | Hepatitis C RNA decreased
Item
detectable hcv rna after 12 weeks if initial peginterferon alfa/ribavirin therapy and <2 log decrease in hcv rna at week 12 from baseline.
boolean
C0369335 (UMLS CUI [1,1])
C3830527 (UMLS CUI [1,2])
C0391001 (UMLS CUI [2])
C0796545 (UMLS CUI [3])
C0035525 (UMLS CUI [4])
C2363763 (UMLS CUI [5])
Hepatitis C virus genotype determination
Item
hcv genotype 2 or 3
boolean
C1533728 (UMLS CUI [1])
Neuropsychiatric syndrome Severe
Item
severe neuropsychiatric disorder.
boolean
C3203509 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Metabolic Disease | Hematological Disease | Lung disease | Myocardial Ischemia | Heart Disease | Heart Disease Unstable | Gastrointestinal Diseases | Nervous system disorder | Kidney Diseases | Urologic Diseases | Endocrine System Diseases | Disorder of eye | Retinal Diseases Severe | Immune System Diseases
Item
history or clinical manifestations of significant metabolic, hematological, pulmonary, ischemic heart disease, significant or unstable heart disease, gastrointestinal, neurological, renal, urological, endocrine, ophthalmologic disorders including severe retinopathy, or immune-mediated disease.
boolean
C0025517 (UMLS CUI [1])
C0018939 (UMLS CUI [2])
C0024115 (UMLS CUI [3])
C0151744 (UMLS CUI [4])
C0018799 (UMLS CUI [5])
C0018799 (UMLS CUI [6,1])
C0443343 (UMLS CUI [6,2])
C0017178 (UMLS CUI [7])
C0027765 (UMLS CUI [8])
C0022658 (UMLS CUI [9])
C0042075 (UMLS CUI [10])
C0014130 (UMLS CUI [11])
C0015397 (UMLS CUI [12])
C0035309 (UMLS CUI [13,1])
C0205082 (UMLS CUI [13,2])
C0021053 (UMLS CUI [14])
HIV Infection | HIV Seropositivity
Item
known hiv infection or positive hiv at screening.
boolean
C0019693 (UMLS CUI [1])
C0019699 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
pregnant or breast-feeding patients.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Autoimmune Disease
Item
underlying autoimmune disease
boolean
C0004364 (UMLS CUI [1])
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