ID

29697

Description

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

Keywords

Versions (1)
  1. 4/13/18 4/13/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 13, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatitis C NCT00627926

English

Eligibility Hepatitis C NCT00627926

1 forms  
Inclusion Criteria
Description

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
Description

Absence Pharmacotherapy Hepatitis C | Absence Investigational New Drugs Hepatitis C

Data type

boolean

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

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
genotype 1, chronic hepatitis c with detectable hepatitis c virus (hcv) ribonucleic acid (rna)
Description

Chronic Hepatitis C Genotype | Hepatitis C virus RNA Detectable

Data type

boolean

Alias
UMLS CUI [1,1]
C0524910
UMLS CUI [1,2]
C1148363
UMLS CUI [2,1]
C0369335
UMLS CUI [2,2]
C3830527
screening laboratory values, tests, and physical exam within acceptable ranges
Description

Normal Laboratory Test Result | Physical Examination Normal

Data type

boolean

Alias
UMLS CUI [1]
C0438214
UMLS CUI [2,1]
C0031809
UMLS CUI [2,2]
C0205307
able and willing to follow contraception requirements
Description

Contraceptive methods Willing

Data type

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
Description

Informed Consent | Protocol Compliance

Data type

boolean

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

Exclusion Criteria

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

Medical contraindication Pegasys | Medical contraindication Copegus

Data type

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
Description

Hepatic decompensation | Liver Cirrhosis

Data type

boolean

Alias
UMLS CUI [1]
C1394798
UMLS CUI [2]
C0023890
history of organ transplant
Description

Organ Transplantation

Data type

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
Description

Medical condition Impact Patient safety | Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C4049986
UMLS CUI [1,3]
C1113679
UMLS CUI [2]
C2348568
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Similar models

Eligibility Hepatitis C NCT00627926

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
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])
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])
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])
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 | Liver Cirrhosis
Item
evidence of hepatic decompensation in cirrhotic subjects
boolean
C1394798 (UMLS CUI [1])
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])
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