ID

39632

Description

Safety and Efficacy of ANA598 Administered With Pegylated Interferon and Ribavirin in Genotype-1 Patients With Chronic HCV Infection; ODM derived from: https://clinicaltrials.gov/show/NCT01281423

Link

https://clinicaltrials.gov/show/NCT01281423

Keywords

Versions (1)
  1. 2/6/20 2/6/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 6, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatitis C NCT01281423

English

Eligibility Hepatitis C NCT01281423

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
documented chronic hepatitis c infection, genotype 1 at screening
Description

Chronic Hepatitis C Genotype

Data type

boolean

Alias
UMLS CUI [1,1]
C0524910
UMLS CUI [1,2]
C1533728
treatment-naïve; no prior exposure to pegylated interferon, ribavirin, or experimental hcv therapy
Description

Therapy naive | Absence Exposure to PEGINTERFERON | Absence Exposure to Ribavirin | Absence Investigational Therapy Hepatitis C

Data type

boolean

Alias
UMLS CUI [1]
C0919936
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C0332157
UMLS CUI [2,3]
C0982327
UMLS CUI [3,1]
C0332197
UMLS CUI [3,2]
C0332157
UMLS CUI [3,3]
C0035525
UMLS CUI [4,1]
C0332197
UMLS CUI [4,2]
C0949266
UMLS CUI [4,3]
C0019196
treatment-experienced patients including partial responders, prior relapse, prior viral breakthrough, and null responders; prior treatment with current standard of care (pegylated interferon alfa and ribavirin)
Description

Therapeutic procedure Experience | Therapy partial responder | Recurrent disease | Viral Breakthrough | Null responder | Standard of Care Previous | pegylated interferon alfa | Ribavirin

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0596545
UMLS CUI [2]
C4285679
UMLS CUI [3]
C0277556
UMLS CUI [4]
C4053869
UMLS CUI [5,1]
C0456148
UMLS CUI [5,2]
C0919876
UMLS CUI [6,1]
C2936643
UMLS CUI [6,2]
C0205156
UMLS CUI [7]
C0907160
UMLS CUI [8]
C0035525
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
female patients who are pregnant or breast feeding
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
infection with non-genotype 1 hcv
Description

Hepatitis C | Exception Hepatitis C virus genotype determination

Data type

boolean

Alias
UMLS CUI [1]
C0019196
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1533728
for treatment-naïve patients: any previous treatment for hcv infection
Description

Patients Therapy naive | Prior Therapy Hepatitis C

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0919936
UMLS CUI [2,1]
C1514463
UMLS CUI [2,2]
C0019196
for treatment-experienced patients: previous treatment with any direct-acting antivirals for hcv infection
Description

Patients Therapeutic procedure Experience | Prior Therapy DIRECT ACTING ANTIVIRALS Hepatitis C

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0596545
UMLS CUI [2,1]
C1514463
UMLS CUI [2,2]
C3653501
UMLS CUI [2,3]
C0019196
known hiv or hbv co-infection
Description

HIV coinfection | HBV coinfection

Data type

boolean

Alias
UMLS CUI [1]
C4062778
UMLS CUI [2]
C2242656
any medical contraindications to peg-inf or rbv therapy
Description

Medical contraindication PEGINTERFERON | Medical contraindication Ribavirin

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0982327
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0035525
history of any other known cause of liver disease
Description

Liver disease Cause Other

Data type

boolean

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0015127
UMLS CUI [1,3]
C0205394
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Similar models

Eligibility Hepatitis C NCT01281423

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Chronic Hepatitis C Genotype
Item
documented chronic hepatitis c infection, genotype 1 at screening
boolean
C0524910 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
Therapy naive | Absence Exposure to PEGINTERFERON | Absence Exposure to Ribavirin | Absence Investigational Therapy Hepatitis C
Item
treatment-naïve; no prior exposure to pegylated interferon, ribavirin, or experimental hcv therapy
boolean
C0919936 (UMLS CUI [1])
C0332197 (UMLS CUI [2,1])
C0332157 (UMLS CUI [2,2])
C0982327 (UMLS CUI [2,3])
C0332197 (UMLS CUI [3,1])
C0332157 (UMLS CUI [3,2])
C0035525 (UMLS CUI [3,3])
C0332197 (UMLS CUI [4,1])
C0949266 (UMLS CUI [4,2])
C0019196 (UMLS CUI [4,3])
Therapeutic procedure Experience | Therapy partial responder | Recurrent disease | Viral Breakthrough | Null responder | Standard of Care Previous | pegylated interferon alfa | Ribavirin
Item
treatment-experienced patients including partial responders, prior relapse, prior viral breakthrough, and null responders; prior treatment with current standard of care (pegylated interferon alfa and ribavirin)
boolean
C0087111 (UMLS CUI [1,1])
C0596545 (UMLS CUI [1,2])
C4285679 (UMLS CUI [2])
C0277556 (UMLS CUI [3])
C4053869 (UMLS CUI [4])
C0456148 (UMLS CUI [5,1])
C0919876 (UMLS CUI [5,2])
C2936643 (UMLS CUI [6,1])
C0205156 (UMLS CUI [6,2])
C0907160 (UMLS CUI [7])
C0035525 (UMLS CUI [8])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
female patients who are pregnant or breast feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Hepatitis C | Exception Hepatitis C virus genotype determination
Item
infection with non-genotype 1 hcv
boolean
C0019196 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1533728 (UMLS CUI [2,2])
Patients Therapy naive | Prior Therapy Hepatitis C
Item
for treatment-naïve patients: any previous treatment for hcv infection
boolean
C0030705 (UMLS CUI [1,1])
C0919936 (UMLS CUI [1,2])
C1514463 (UMLS CUI [2,1])
C0019196 (UMLS CUI [2,2])
Patients Therapeutic procedure Experience | Prior Therapy DIRECT ACTING ANTIVIRALS Hepatitis C
Item
for treatment-experienced patients: previous treatment with any direct-acting antivirals for hcv infection
boolean
C0030705 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0596545 (UMLS CUI [1,3])
C1514463 (UMLS CUI [2,1])
C3653501 (UMLS CUI [2,2])
C0019196 (UMLS CUI [2,3])
HIV coinfection | HBV coinfection
Item
known hiv or hbv co-infection
boolean
C4062778 (UMLS CUI [1])
C2242656 (UMLS CUI [2])
Medical contraindication PEGINTERFERON | Medical contraindication Ribavirin
Item
any medical contraindications to peg-inf or rbv therapy
boolean
C1301624 (UMLS CUI [1,1])
C0982327 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0035525 (UMLS CUI [2,2])
Liver disease Cause Other
Item
history of any other known cause of liver disease
boolean
C0023895 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
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