ID

39668

Description

Proof of Concept Study for Safety and Efficacy of EDP239 in Hepatitis C Subjects; ODM derived from: https://clinicaltrials.gov/show/NCT01856426

Link

https://clinicaltrials.gov/show/NCT01856426

Keywords

Versions (1)
  1. 2/9/20 2/9/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 9, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatitis C NCT01856426

English

Eligibility Hepatitis C NCT01856426

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects must have chronic genotype-1 hepatitis c virus infection and plasma hcv-rna
Description

Chronic Hepatitis C Genotype

Data type

boolean

Alias
UMLS CUI [1,1]
C0524910
UMLS CUI [1,2]
C1533728
≥ 105 iu/ml at the time of screening.
Description

Hepatitis C virus RNA assay Plasma

Data type

boolean

Alias
UMLS CUI [1,1]
C1272251
UMLS CUI [1,2]
C0032105
subjects must have chronic hcv infection as determined by any of the following:
Description

Hepatitis C, Chronic

Data type

boolean

Alias
UMLS CUI [1]
C0524910
be anti-hcv (+) for at least 6 months per subject history or medical records
Description

Hepatitis C antibody positive Duration

Data type

boolean

Alias
UMLS CUI [1,1]
C0281863
UMLS CUI [1,2]
C0449238
an anti-hcv test, viral load, or genotype > 6 months ago
Description

Hepatitis C antibody test | Viral load | Genotype determination

Data type

boolean

Alias
UMLS CUI [1]
C0201487
UMLS CUI [2]
C1261478
UMLS CUI [3]
C1285573
in the setting of a recent positive anti-hcv test (< 6 months), liver biopsy demonstrating chronicity
Description

Hepatitis C antibody test Positive | Chronicity Biopsy of liver

Data type

boolean

Alias
UMLS CUI [1,1]
C0201487
UMLS CUI [1,2]
C1514241
UMLS CUI [2,1]
C0547045
UMLS CUI [2,2]
C0193388
subjects must have il-28b genotype "cc"
Description

IL-28B Genotype

Data type

boolean

Alias
UMLS CUI [1,1]
C1425475
UMLS CUI [1,2]
C1285573
subjects must weigh at least 50 kg to participate in the study, and must have a body mass index (bmi) within the range of 18 - 36 kg/m2. bmi = body weight (kg) / [height (m)]2
Description

Body Weight | Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C0005910
UMLS CUI [2]
C1305855
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 30 days (for small molecules) whichever is longer; or longer if required by local regulations.
Description

Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013230
previous treatment, including the use of any investigational agents, for the treatment of hcv infection.
Description

Prior Therapy Hepatitis C | Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0019196
UMLS CUI [2]
C0013230
women of child bearing potential.
Description

Childbearing Potential

Data type

boolean

Alias
UMLS CUI [1]
C3831118
subjects with il-28b genotype "ct or tt".
Description

IL-28B Genotype

Data type

boolean

Alias
UMLS CUI [1,1]
C1425475
UMLS CUI [1,2]
C1285573
alt γ-gt, and ast must be below 5 x the upper limit of normal (uln).
Description

Alanine aminotransferase measurement | Gamma glutamyl transferase measurement | Aspartate aminotransferase measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201836
UMLS CUI [2]
C0202035
UMLS CUI [3]
C0201899
serum bilirubin must not exceed uln.
Description

Serum total bilirubin measurement

Data type

boolean

Alias
UMLS CUI [1]
C1278039
the pt (inr) must be within normal limits.
Description

Prothrombin time assay | International Normalized Ratio

Data type

boolean

Alias
UMLS CUI [1]
C0033707
UMLS CUI [2]
C0525032
if necessary, laboratory testing may be repeated on one occasion (as soon as possible) prior to randomization, to rule out any laboratory error.
Description

Laboratory Procedure Repeated | Errors Excluded

Data type

boolean

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0205341
UMLS CUI [2,1]
C0743559
UMLS CUI [2,2]
C0332196
use of drugs that inhibit or induce cyp3a4.
Description

CYP3A4 Inhibitors | CYP3A4 Inducers

Data type

boolean

Alias
UMLS CUI [1]
C3850053
UMLS CUI [2]
C3850041
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Similar models

Eligibility Hepatitis C NCT01856426

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Chronic Hepatitis C Genotype
Item
subjects must have chronic genotype-1 hepatitis c virus infection and plasma hcv-rna
boolean
C0524910 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
Hepatitis C virus RNA assay Plasma
Item
≥ 105 iu/ml at the time of screening.
boolean
C1272251 (UMLS CUI [1,1])
C0032105 (UMLS CUI [1,2])
Hepatitis C, Chronic
Item
subjects must have chronic hcv infection as determined by any of the following:
boolean
C0524910 (UMLS CUI [1])
Hepatitis C antibody positive Duration
Item
be anti-hcv (+) for at least 6 months per subject history or medical records
boolean
C0281863 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Hepatitis C antibody test | Viral load | Genotype determination
Item
an anti-hcv test, viral load, or genotype > 6 months ago
boolean
C0201487 (UMLS CUI [1])
C1261478 (UMLS CUI [2])
C1285573 (UMLS CUI [3])
Hepatitis C antibody test Positive | Chronicity Biopsy of liver
Item
in the setting of a recent positive anti-hcv test (< 6 months), liver biopsy demonstrating chronicity
boolean
C0201487 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
C0547045 (UMLS CUI [2,1])
C0193388 (UMLS CUI [2,2])
IL-28B Genotype
Item
subjects must have il-28b genotype "cc"
boolean
C1425475 (UMLS CUI [1,1])
C1285573 (UMLS CUI [1,2])
Body Weight | Body mass index
Item
subjects must weigh at least 50 kg to participate in the study, and must have a body mass index (bmi) within the range of 18 - 36 kg/m2. bmi = body weight (kg) / [height (m)]2
boolean
C0005910 (UMLS CUI [1])
C1305855 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Investigational New Drugs
Item
use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 30 days (for small molecules) whichever is longer; or longer if required by local regulations.
boolean
C0013230 (UMLS CUI [1])
Prior Therapy Hepatitis C | Investigational New Drugs
Item
previous treatment, including the use of any investigational agents, for the treatment of hcv infection.
boolean
C1514463 (UMLS CUI [1,1])
C0019196 (UMLS CUI [1,2])
C0013230 (UMLS CUI [2])
Childbearing Potential
Item
women of child bearing potential.
boolean
C3831118 (UMLS CUI [1])
IL-28B Genotype
Item
subjects with il-28b genotype "ct or tt".
boolean
C1425475 (UMLS CUI [1,1])
C1285573 (UMLS CUI [1,2])
Alanine aminotransferase measurement | Gamma glutamyl transferase measurement | Aspartate aminotransferase measurement
Item
alt γ-gt, and ast must be below 5 x the upper limit of normal (uln).
boolean
C0201836 (UMLS CUI [1])
C0202035 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
Serum total bilirubin measurement
Item
serum bilirubin must not exceed uln.
boolean
C1278039 (UMLS CUI [1])
Prothrombin time assay | International Normalized Ratio
Item
the pt (inr) must be within normal limits.
boolean
C0033707 (UMLS CUI [1])
C0525032 (UMLS CUI [2])
Laboratory Procedure Repeated | Errors Excluded
Item
if necessary, laboratory testing may be repeated on one occasion (as soon as possible) prior to randomization, to rule out any laboratory error.
boolean
C0022885 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
C0743559 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
CYP3A4 Inhibitors | CYP3A4 Inducers
Item
use of drugs that inhibit or induce cyp3a4.
boolean
C3850053 (UMLS CUI [1])
C3850041 (UMLS CUI [2])
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