ID

39707

Description

Efficacy and Safety Study of DEB025/Alisporivir Combined to Peg-IFN and Ribavirin in Chronic Hepatitis C Genotype 1 Treatment-naïve Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01318694

Link

https://clinicaltrials.gov/show/NCT01318694

Keywords

Versions (1)
  1. 2/11/20 2/11/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 11, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatitis C, Chronic NCT01318694

English

Eligibility Hepatitis C, Chronic NCT01318694

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
chronic hepatitis c viral
Description

Hepatitis C, Chronic

Data type

boolean

Alias
UMLS CUI [1]
C0524910
hcv genotype
Description

Hepatitis C virus Genotype

Data type

boolean

Alias
UMLS CUI [1]
C1533728
no previous treatment for hepatitis c infection
Description

Prior Therapy Absent Hepatitis C

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0019196
serum hcv rna level ≥ 1000 iu/ml assessed by quantitative polymerase chain reaction or equivalent at screening, no upper limit
Description

Hepatitis C virus RNA assay Serum Quantitative Polymerase Chain Reaction

Data type

boolean

Alias
UMLS CUI [1,1]
C1272251
UMLS CUI [1,2]
C0229671
UMLS CUI [1,3]
C1709846
liver evaluation prior to baseline: liver biopsy within 3 years or fibroscan within 6 months
Description

Evaluation Liver | Biopsy of liver | Fibroscan

Data type

boolean

Alias
UMLS CUI [1,1]
C1261322
UMLS CUI [1,2]
C0023884
UMLS CUI [2]
C0193388
UMLS CUI [3]
C4522043
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
hcv genotype different from genotype 1 or co-infection with other hcv genotype
Description

Hepatitis C virus genotype | HCV coinfection HCV Genotype Different

Data type

boolean

Alias
UMLS CUI [1]
C1533728
UMLS CUI [2,1]
C1698259
UMLS CUI [2,2]
C1533728
UMLS CUI [2,3]
C1705242
co-infection with hepatitis b or hiv
Description

HBV coinfection | HIV coinfection

Data type

boolean

Alias
UMLS CUI [1]
C2242656
UMLS CUI [2]
C4062778
any other cause of relevant liver disease other than hcv
Description

Liver disease | Etiology Except Hepatitis C virus

Data type

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0332300
UMLS CUI [2,3]
C0220847
presence or history of hepatic decompensation
Description

Hepatic decompensation

Data type

boolean

Alias
UMLS CUI [1]
C1394798
alt ≥ 10 times uln, more than 1 episode of elevated bilirubin (>uln) in past 6 months
Description

Alanine aminotransferase increased | Episode Quantity Elevated total bilirubin

Data type

boolean

Alias
UMLS CUI [1]
C0151905
UMLS CUI [2,1]
C0332189
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0741494
other protocol-defined inclusion/exclusion criteria may apply
Description

Eligibility Criteria Study Protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348563
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Similar models

Eligibility Hepatitis C, Chronic NCT01318694

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Hepatitis C, Chronic
Item
chronic hepatitis c viral
boolean
C0524910 (UMLS CUI [1])
Hepatitis C virus Genotype
Item
hcv genotype
boolean
C1533728 (UMLS CUI [1])
Prior Therapy Absent Hepatitis C
Item
no previous treatment for hepatitis c infection
boolean
C1514463 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0019196 (UMLS CUI [1,3])
Hepatitis C virus RNA assay Serum Quantitative Polymerase Chain Reaction
Item
serum hcv rna level ≥ 1000 iu/ml assessed by quantitative polymerase chain reaction or equivalent at screening, no upper limit
boolean
C1272251 (UMLS CUI [1,1])
C0229671 (UMLS CUI [1,2])
C1709846 (UMLS CUI [1,3])
Evaluation Liver | Biopsy of liver | Fibroscan
Item
liver evaluation prior to baseline: liver biopsy within 3 years or fibroscan within 6 months
boolean
C1261322 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C0193388 (UMLS CUI [2])
C4522043 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Hepatitis C virus genotype | HCV coinfection HCV Genotype Different
Item
hcv genotype different from genotype 1 or co-infection with other hcv genotype
boolean
C1533728 (UMLS CUI [1])
C1698259 (UMLS CUI [2,1])
C1533728 (UMLS CUI [2,2])
C1705242 (UMLS CUI [2,3])
HBV coinfection | HIV coinfection
Item
co-infection with hepatitis b or hiv
boolean
C2242656 (UMLS CUI [1])
C4062778 (UMLS CUI [2])
Liver disease | Etiology Except Hepatitis C virus
Item
any other cause of relevant liver disease other than hcv
boolean
C0023895 (UMLS CUI [1])
C0015127 (UMLS CUI [2,1])
C0332300 (UMLS CUI [2,2])
C0220847 (UMLS CUI [2,3])
Hepatic decompensation
Item
presence or history of hepatic decompensation
boolean
C1394798 (UMLS CUI [1])
Alanine aminotransferase increased | Episode Quantity Elevated total bilirubin
Item
alt ≥ 10 times uln, more than 1 episode of elevated bilirubin (>uln) in past 6 months
boolean
C0151905 (UMLS CUI [1])
C0332189 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0741494 (UMLS CUI [2,3])
Eligibility Criteria Study Protocol
Item
other protocol-defined inclusion/exclusion criteria may apply
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
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