ID

41435

Beskrivning

Pharmacokinetics of Multiple Ascending Doses of VCH-222 in Subjects With Chronic Hepatitis C Infection; ODM derived from: https://clinicaltrials.gov/show/NCT00911963

Länk

https://clinicaltrials.gov/show/NCT00911963

Nyckelord

Versioner (2)
  1. 2019-01-16 2019-01-16 -
  2. 2020-10-07 2020-10-07 -
Rättsinnehavare

see on clinicaltrials.gov

Uppladdad den

7 oktober 2020

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Hepatitis C NCT00911963

Engelsk

Eligibility Hepatitis C NCT00911963

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
male and female subjects, 18-65 years of age (females non-child bearing potential in part b)
Beskrivning

Age, Gender, non-child bearing potential

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0332197
have laboratory evidence of hcv infection for 6 months, defined by (1) presence of anti-hcv antibody (genotype 1a and 1b infection), or (2)documented hcv rna presence by a sensitive and specific assay and (3 histologic evidence of chc (fibrosis on a standardized histological grading system)
Beskrivning

HCV infection (anti-HCV-antibodies, HCV-RNA presence and histological evidence of chronic Hepatitis C)

Datatyp

boolean

Alias
UMLS CUI [1]
C0019196
UMLS CUI [2,1]
C0166049
UMLS CUI [2,2]
C0017431
UMLS CUI [3,1]
C0369335
UMLS CUI [3,2]
C0150312
UMLS CUI [4,1]
C0449575
UMLS CUI [4,2]
C0524910
UMLS CUI [4,3]
C0239946
UMLS CUI [4,4]
C0919553
plasma hcv rna of 100,000 iu/ml
Beskrivning

plasma hcv rna

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0369335
UMLS CUI [1,2]
C0032105
hiv 1 and hiv2 ab seronegative
Beskrivning

HIV 1 and 2 antibody seronegative

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0919674
UMLS CUI [1,2]
C0369497
UMLS CUI [2,1]
C0919674
UMLS CUI [2,2]
C1255639
body mass index (bmi) ≤ 35 kg/m2 bmi
Beskrivning

BMI

Datatyp

boolean

Alias
UMLS CUI [1]
C1305855
treatment naive subjects
Beskrivning

Untreated

Datatyp

boolean

Alias
UMLS CUI [1]
C0332155
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
contraindications to peginterferon or ribavirin therapy
Beskrivning

Contraindications to peginterferon or ribavirin therapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0522473
UMLS CUI [1,2]
C0982327
UMLS CUI [2,1]
C0522473
UMLS CUI [2,2]
C0035525
have evidence of liver cirrhosis, decompensated liver disease, and child-pugh score > 5
Beskrivning

Liver cirrhosis, decompensated liver disease (Child-Pugh)

Datatyp

boolean

Alias
UMLS CUI [1]
C0023890
UMLS CUI [2]
C4075847
UMLS CUI [3]
C4050412
have hemoglobinopathies, unstable cardiac disease, history of organ transplant, active malignant disease or uncontrolled type i or ii diabetes
Beskrivning

Hemoglobinopathies, unstable cardiac disease, history of organ transplant, active malignant disease or uncontrolled diabetes

Datatyp

boolean

Alias
UMLS CUI [1]
C0019045
UMLS CUI [2,1]
C0018799
UMLS CUI [2,2]
C0443343
UMLS CUI [3,1]
C0029216
UMLS CUI [3,2]
C0262926
UMLS CUI [4,1]
C0442867
UMLS CUI [4,2]
C0205177
UMLS CUI [5,1]
C0011849
UMLS CUI [5,2]
C0205318
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Similar models

Eligibility Hepatitis C NCT00911963

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age, Gender, non-child bearing potential
Item
male and female subjects, 18-65 years of age (females non-child bearing potential in part b)
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
HCV infection (anti-HCV-antibodies, HCV-RNA presence and histological evidence of chronic Hepatitis C)
Item
have laboratory evidence of hcv infection for 6 months, defined by (1) presence of anti-hcv antibody (genotype 1a and 1b infection), or (2)documented hcv rna presence by a sensitive and specific assay and (3 histologic evidence of chc (fibrosis on a standardized histological grading system)
boolean
C0019196 (UMLS CUI [1])
C0166049 (UMLS CUI [2,1])
C0017431 (UMLS CUI [2,2])
C0369335 (UMLS CUI [3,1])
C0150312 (UMLS CUI [3,2])
C0449575 (UMLS CUI [4,1])
C0524910 (UMLS CUI [4,2])
C0239946 (UMLS CUI [4,3])
C0919553 (UMLS CUI [4,4])
plasma hcv rna
Item
plasma hcv rna of 100,000 iu/ml
boolean
C0369335 (UMLS CUI [1,1])
C0032105 (UMLS CUI [1,2])
HIV 1 and 2 antibody seronegative
Item
hiv 1 and hiv2 ab seronegative
boolean
C0919674 (UMLS CUI [1,1])
C0369497 (UMLS CUI [1,2])
C0919674 (UMLS CUI [2,1])
C1255639 (UMLS CUI [2,2])
BMI
Item
body mass index (bmi) ≤ 35 kg/m2 bmi
boolean
C1305855 (UMLS CUI [1])
Untreated
Item
treatment naive subjects
boolean
C0332155 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Contraindications to peginterferon or ribavirin therapy
Item
contraindications to peginterferon or ribavirin therapy
boolean
C0522473 (UMLS CUI [1,1])
C0982327 (UMLS CUI [1,2])
C0522473 (UMLS CUI [2,1])
C0035525 (UMLS CUI [2,2])
Liver cirrhosis, decompensated liver disease (Child-Pugh)
Item
have evidence of liver cirrhosis, decompensated liver disease, and child-pugh score > 5
boolean
C0023890 (UMLS CUI [1])
C4075847 (UMLS CUI [2])
C4050412 (UMLS CUI [3])
Hemoglobinopathies, unstable cardiac disease, history of organ transplant, active malignant disease or uncontrolled diabetes
Item
have hemoglobinopathies, unstable cardiac disease, history of organ transplant, active malignant disease or uncontrolled type i or ii diabetes
boolean
C0019045 (UMLS CUI [1])
C0018799 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
C0029216 (UMLS CUI [3,1])
C0262926 (UMLS CUI [3,2])
C0442867 (UMLS CUI [4,1])
C0205177 (UMLS CUI [4,2])
C0011849 (UMLS CUI [5,1])
C0205318 (UMLS CUI [5,2])
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