ID

34323

Descripción

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

Link

https://clinicaltrials.gov/show/NCT00911963

Palabras clave

  1. 16/1/19 16/1/19 -
  2. 7/10/20 7/10/20 -
Titular de derechos de autor

see on clinicaltrials.gov

Subido en

16 de enero de 2019

DOI

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Licencia

Creative Commons BY 4.0

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Eligibility Hepatitis C NCT00911963

Eligibility Hepatitis C NCT00911963

Inclusion Criteria
Descripción

Inclusion Criteria

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

ID.1

Tipo de datos

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)
Descripción

ID.2

Tipo de datos

boolean

plasma hcv rna of 100,000 iu/ml
Descripción

ID.3

Tipo de datos

boolean

hiv 1 and hiv2 ab seronegative
Descripción

ID.4

Tipo de datos

boolean

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

ID.5

Tipo de datos

boolean

treatment naive subjects
Descripción

ID.6

Tipo de datos

boolean

Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
contraindications to peginterferon or ribavirin therapy
Descripción

ID.7

Tipo de datos

boolean

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

ID.8

Tipo de datos

boolean

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

ID.9

Tipo de datos

boolean

Similar models

Eligibility Hepatitis C NCT00911963

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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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