Informações:
Falhas:
ID
29697
Descrição
A Phase 3 Study of Telaprevir in Combination With Pegasys® and Copegus® in Treatment-Naive Subjects With Genotype 1 Hepatitis C Virus (HCV); ODM derived from: https://clinicaltrials.gov/show/NCT00627926
Link
https://clinicaltrials.gov/show/NCT00627926
Palavras-chave
Versões (1)
- 13/04/2018 13/04/2018 -
Titular dos direitos
See clinicaltrials.gov
Transferido a
13 de abril de 2018
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Hepatitis C NCT00627926
Eligibility Hepatitis C NCT00627926
- StudyEvent: Eligibility
Similar models
Eligibility Hepatitis C NCT00627926
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Absence Pharmacotherapy Hepatitis C | Absence Investigational New Drugs Hepatitis C
Item
has not received any previous treatment with any approved or investigational drug or drug regimen for the treatment of hepatitis c
boolean
C0332197 (UMLS CUI [1,1])
C0013216 (UMLS CUI [1,2])
C0019196 (UMLS CUI [1,3])
C0332197 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C0019196 (UMLS CUI [2,3])
C0013216 (UMLS CUI [1,2])
C0019196 (UMLS CUI [1,3])
C0332197 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C0019196 (UMLS CUI [2,3])
Age
Item
male and female subjects, 18 to 70 years of age, inclusive
boolean
C0001779 (UMLS CUI [1])
Chronic Hepatitis C Genotype | Hepatitis C virus RNA Detectable
Item
genotype 1, chronic hepatitis c with detectable hepatitis c virus (hcv) ribonucleic acid (rna)
boolean
C0524910 (UMLS CUI [1,1])
C1148363 (UMLS CUI [1,2])
C0369335 (UMLS CUI [2,1])
C3830527 (UMLS CUI [2,2])
C1148363 (UMLS CUI [1,2])
C0369335 (UMLS CUI [2,1])
C3830527 (UMLS CUI [2,2])
Normal Laboratory Test Result | Physical Examination Normal
Item
screening laboratory values, tests, and physical exam within acceptable ranges
boolean
C0438214 (UMLS CUI [1])
C0031809 (UMLS CUI [2,1])
C0205307 (UMLS CUI [2,2])
C0031809 (UMLS CUI [2,1])
C0205307 (UMLS CUI [2,2])
Contraceptive methods Willing
Item
able and willing to follow contraception requirements
boolean
C0700589 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
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])
C0525058 (UMLS CUI [2])
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])
C1176430 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C1170183 (UMLS CUI [2,2])
Hepatic decompensation | Liver Cirrhosis
Item
evidence of hepatic decompensation in cirrhotic subjects
boolean
C1394798 (UMLS CUI [1])
C0023890 (UMLS CUI [2])
C0023890 (UMLS CUI [2])
Organ Transplantation
Item
history of organ transplant
boolean
C0029216 (UMLS CUI [1])
Medical condition Impact Patient safety | Study Subject Participation Status
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])
C2348568 (UMLS CUI [2])
C4049986 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
C2348568 (UMLS CUI [2])