ID

34323

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

  1. 2019-01-16 2019-01-16 -
  2. 2020-10-07 2020-10-07 -
Rättsinnehavare

see on clinicaltrials.gov

Uppladdad den

16 januari 2019

DOI

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Licens

Creative Commons BY 4.0

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Eligibility Hepatitis C NCT00911963

Eligibility Hepatitis C NCT00911963

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

ID.1

Datatyp

boolean

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

ID.2

Datatyp

boolean

plasma hcv rna of 100,000 iu/ml
Beskrivning

ID.3

Datatyp

boolean

hiv 1 and hiv2 ab seronegative
Beskrivning

ID.4

Datatyp

boolean

body mass index (bmi) ≤ 35 kg/m2 bmi
Beskrivning

ID.5

Datatyp

boolean

treatment naive subjects
Beskrivning

ID.6

Datatyp

boolean

Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
contraindications to peginterferon or ribavirin therapy
Beskrivning

ID.7

Datatyp

boolean

have evidence of liver cirrhosis, decompensated liver disease, and child-pugh score > 5
Beskrivning

ID.8

Datatyp

boolean

have hemoglobinopathies, unstable cardiac disease, history of organ transplant, active malignant disease or uncontrolled type i or ii diabetes
Beskrivning

ID.9

Datatyp

boolean

Similar models

Eligibility Hepatitis C NCT00911963

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
ID.1
Item
male and female subjects, 18-65 years of age (females non-child bearing potential in part b)
boolean
ID.2
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
ID.3
Item
plasma hcv rna of 100,000 iu/ml
boolean
ID.4
Item
hiv 1 and hiv2 ab seronegative
boolean
ID.5
Item
body mass index (bmi) ≤ 35 kg/m2 bmi
boolean
ID.6
Item
treatment naive subjects
boolean
Item Group
C0680251 (UMLS CUI)
ID.7
Item
contraindications to peginterferon or ribavirin therapy
boolean
ID.8
Item
have evidence of liver cirrhosis, decompensated liver disease, and child-pugh score > 5
boolean
ID.9
Item
have hemoglobinopathies, unstable cardiac disease, history of organ transplant, active malignant disease or uncontrolled type i or ii diabetes
boolean

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