ID

36099

Description

A Study of RO5024048 in Combination With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin) in Patients With Chronic Hepatitis C Genotype 1 or 4; ODM derived from: https://clinicaltrials.gov/show/NCT01057667

Link

https://clinicaltrials.gov/show/NCT01057667

Keywords

Versions (3)
  1. 1/16/19 1/16/19 -
  2. 4/14/19 4/14/19 -
  3. 4/15/19 4/15/19 -
Copyright Holder

Hoffmann-La Roche

Uploaded on

April 15, 2019

DOI

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License

Creative Commons BY-NC 3.0
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RO5024048 in Combination with Pegasys and Copegus in Chronic Hep C NCT01057667

English

Eligibility Criteria

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Criteria
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
Is the patient of 18-70 years of age?
Description

adult patients, 18-70 years of age (can be included)

Data type

boolean

Alias
UMLS CUI [1]
C0001779
Does the patient have Hepatitis C (genotype 1 or 4) for more than 6 months?
Description

patients with hepatitis c, genotype 1 or 4, of over 6 months duration (can be included)

Data type

boolean

Alias
UMLS CUI [1,1]
C0524910
UMLS CUI [1,2]
C3532919
UMLS CUI [2,1]
C0524910
UMLS CUI [2,2]
C3532922
Is the patient treatment-naïve?
Description

treatment-naïve patient(s) (can be included)

Data type

boolean

Alias
UMLS CUI [1]
C0919936
Is the pregnancy test negative and are two contraception methods being used?
Description

negative pregnancy test required; female patients of childbearing age and male patients with female partners of childbearing age must use two forms of contraception during treatment and following the last dose of ribavirin in accordance with locally approved label for ribavirin

Data type

boolean

Alias
UMLS CUI [1]
C0427780
UMLS CUI [2]
C0700589
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
Is the patient pregnant or breast-feeding or has a pregnant partner?
Description

pregnant or breast feeding females or male partners of pregnant females (are to be included)

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0919624
Was there previous interferon or ribavirin based therapy or an investigational anti-hcv agent?
Description

Patients with previous interferon or ribavirin based therapy or investigational anti-hcv agent (are to be excluded)

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0035525
UMLS CUI [2,1]
C1514463
UMLS CUI [2,2]
C3652465
UMLS CUI [3,1]
C1514463
UMLS CUI [3,2]
C0019196
UMLS CUI [3,3]
C0013230
Was there systemic antiviral therapy with established or perceived activity against hcv </=3 months prior to first dose of study drug?
Description

systemic antiviral therapy with established or perceived activity against hcv </=3 months prior to first dose of study drug

Data type

boolean

Alias
UMLS CUI [1,1]
C0280274
UMLS CUI [1,2]
C0205373
UMLS CUI [1,3]
C0441655
UMLS CUI [1,4]
C0521124
UMLS CUI [1,5]
C0524910
UMLS CUI [1,6]
C0332185
Was there a Hepatitis A or B, or HIV infection?
Description

Patients with hepatitis a or b, or hiv infection (are to be excluded)

Data type

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2,1]
C0019163
UMLS CUI [2,2]
C3714514
UMLS CUI [3,1]
C0019159
UMLS CUI [3,2]
C3714514
Is there a history or evidence of a medical condition associated with chronic liver disease other than HCV?
Description

Patients with history or evidence of medical condition associated with chronic liver disease other than hcv (are to be excluded)

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C0332281
UMLS CUI [1,4]
C0341439
UMLS CUI [2,1]
C3887511
UMLS CUI [2,2]
C0012634
UMLS CUI [2,3]
C0332281
UMLS CUI [2,4]
C0341439
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Similar models

Eligibility Criteria

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Criteria
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
Is the patient of 18-70 years of age?
boolean
C0001779 (UMLS CUI [1])
Chronic Hepatitis C
Item
Does the patient have Hepatitis C (genotype 1 or 4) for more than 6 months?
boolean
C0524910 (UMLS CUI [1,1])
C3532919 (UMLS CUI [1,2])
C0524910 (UMLS CUI [2,1])
C3532922 (UMLS CUI [2,2])
Treament-naïve
Item
Is the patient treatment-naïve?
boolean
C0919936 (UMLS CUI [1])
Possibility of pregnacy
Item
Is the pregnancy test negative and are two contraception methods being used?
boolean
C0427780 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Confirmed pregnancy
Item
Is the patient pregnant or breast-feeding or has a pregnant partner?
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0919624 (UMLS CUI [3])
Previous Treatment for Hep C
Item
Was there previous interferon or ribavirin based therapy or an investigational anti-hcv agent?
boolean
C1514463 (UMLS CUI [1,1])
C0035525 (UMLS CUI [1,2])
C1514463 (UMLS CUI [2,1])
C3652465 (UMLS CUI [2,2])
C1514463 (UMLS CUI [3,1])
C0019196 (UMLS CUI [3,2])
C0013230 (UMLS CUI [3,3])
Confounding antiviral therapy
Item
Was there systemic antiviral therapy with established or perceived activity against hcv </=3 months prior to first dose of study drug?
boolean
C0280274 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C0441655 (UMLS CUI [1,3])
C0521124 (UMLS CUI [1,4])
C0524910 (UMLS CUI [1,5])
C0332185 (UMLS CUI [1,6])
Different Hepatits and HIV
Item
Was there a Hepatitis A or B, or HIV infection?
boolean
C0019693 (UMLS CUI [1])
C0019163 (UMLS CUI [2,1])
C3714514 (UMLS CUI [2,2])
C0019159 (UMLS CUI [3,1])
C3714514 (UMLS CUI [3,2])
Chronic liver disease
Item
Is there a history or evidence of a medical condition associated with chronic liver disease other than HCV?
boolean
C0262926 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0332281 (UMLS CUI [1,3])
C0341439 (UMLS CUI [1,4])
C3887511 (UMLS CUI [2,1])
C0012634 (UMLS CUI [2,2])
C0332281 (UMLS CUI [2,3])
C0341439 (UMLS CUI [2,4])
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