ID

29711

Descripción

A Study Evaluating 24-Week and 48-Week Telaprevir-Based Regimen in Treatment Naïve Subjects With Genotype 1 Chronic Hepatitis C Who Achieve an Extended Rapid Viral Response; ODM derived from: https://clinicaltrials.gov/show/NCT00758043

Link

https://clinicaltrials.gov/show/NCT00758043

Palabras clave

Versiones (1)
  1. 15/4/18 15/4/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

15 de abril de 2018

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Hepatitis C NCT00758043

Inglés

Eligibility Hepatitis C NCT00758043

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
has not received any previous treatment with any approved or investigational drug or drug regimen for the treatment of hepatitis c
Descripción

Hepatitis C untreated | Pharmaceutical Preparations Absent | Investigational New Drugs Absent | Pharmacotherapy Absent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0019196
UMLS CUI [1,2]
C0332155
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0013230
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0013216
UMLS CUI [4,2]
C0332197
male and female subjects, 18 to 70 years of age, inclusive
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
genotype 1, chronic hepatitis c with detectable hcv rna.
Descripción

Hepatitis C virus genotype determination | Hepatitis C, Chronic | HCV RNA Detectable

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1533728
UMLS CUI [2]
C0524910
UMLS CUI [3,1]
C0369335
UMLS CUI [3,2]
C3830527
screening laboratory values, tests, and physical exam within acceptable ranges
Descripción

Laboratory Results Acceptable | Laboratory Procedures Acceptable | Physical Examination Acceptable

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C1879533
UMLS CUI [2,1]
C0022885
UMLS CUI [2,2]
C1879533
UMLS CUI [3,1]
C0031809
UMLS CUI [3,2]
C1879533
able and willing to follow contraception requirements
Descripción

Contraceptive methods Willing

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C0600109
able to read and understand, and willing to sign the informed consent form and abide by the study restrictions.
Descripción

Informed Consent | Protocol Compliance

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C0525058
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
subject has any contraindications to pegasys® or copegus® therapy
Descripción

Medical contraindication Pegasys | Medical contraindication Copegus

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C1176430
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C1170183
evidence of hepatic decompensation in cirrhotic subjects
Descripción

Hepatic decompensation | Subject Cirrhotic

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1394798
UMLS CUI [2,1]
C0681850
UMLS CUI [2,2]
C0439686
history of organ transplant
Descripción

Organ Transplantation

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0029216
history of, or any current medical condition which could impact the safety of the subject in participation in the study
Descripción

Medical condition Impact Patient safety

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C4049986
UMLS CUI [1,3]
C1113679
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Similar models

Eligibility Hepatitis C NCT00758043

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Hepatitis C untreated | Pharmaceutical Preparations Absent | Investigational New Drugs Absent | Pharmacotherapy Absent
Item
has not received any previous treatment with any approved or investigational drug or drug regimen for the treatment of hepatitis c
boolean
C0019196 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0013230 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0013216 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Age
Item
male and female subjects, 18 to 70 years of age, inclusive
boolean
C0001779 (UMLS CUI [1])
Hepatitis C virus genotype determination | Hepatitis C, Chronic | HCV RNA Detectable
Item
genotype 1, chronic hepatitis c with detectable hcv rna.
boolean
C1533728 (UMLS CUI [1])
C0524910 (UMLS CUI [2])
C0369335 (UMLS CUI [3,1])
C3830527 (UMLS CUI [3,2])
Laboratory Results Acceptable | Laboratory Procedures Acceptable | Physical Examination Acceptable
Item
screening laboratory values, tests, and physical exam within acceptable ranges
boolean
C1254595 (UMLS CUI [1,1])
C1879533 (UMLS CUI [1,2])
C0022885 (UMLS CUI [2,1])
C1879533 (UMLS CUI [2,2])
C0031809 (UMLS CUI [3,1])
C1879533 (UMLS CUI [3,2])
Contraceptive methods Willing
Item
able and willing to follow contraception requirements
boolean
C0700589 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
Informed Consent | Protocol Compliance
Item
able to read and understand, and willing to sign the informed consent form and abide by the study restrictions.
boolean
C0021430 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Medical contraindication Pegasys | Medical contraindication Copegus
Item
subject has any contraindications to pegasys® or copegus® therapy
boolean
C1301624 (UMLS CUI [1,1])
C1176430 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C1170183 (UMLS CUI [2,2])
Hepatic decompensation | Subject Cirrhotic
Item
evidence of hepatic decompensation in cirrhotic subjects
boolean
C1394798 (UMLS CUI [1])
C0681850 (UMLS CUI [2,1])
C0439686 (UMLS CUI [2,2])
Organ Transplantation
Item
history of organ transplant
boolean
C0029216 (UMLS CUI [1])
Medical condition Impact Patient safety
Item
history of, or any current medical condition which could impact the safety of the subject in participation in the study
boolean
C3843040 (UMLS CUI [1,1])
C4049986 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
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