ID

39744

Description

Open-Label Safety Study of Telaprevir and Sofosbuvir in Chronic Hepatitis C Genotype 1; ODM derived from: https://clinicaltrials.gov/show/NCT01994486

Link

https://clinicaltrials.gov/show/NCT01994486

Keywords

Versions (1)
  1. 2/15/20 2/15/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 15, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatitis C, Chronic NCT01994486

English

Eligibility Hepatitis C, Chronic NCT01994486

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
willing and able to provide informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
bmi (body mass index) ≥ 18 kg/m2
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
hcv rna quantifiable at screening and >1,000 iu/ml
Description

Hepatitis C virus RNA assay

Data type

boolean

Alias
UMLS CUI [1]
C1272251
hcv treatment naïve
Description

Therapy naive HCV

Data type

boolean

Alias
UMLS CUI [1,1]
C0919936
UMLS CUI [1,2]
C0220847
hcv genotype 1
Description

Hepatitis C virus genotype

Data type

boolean

Alias
UMLS CUI [1]
C1533728
7. confirmation of chronic hcv infection documented by either: a positive anti-hcv antibody test or positive hcv rna or positive hcv genotyping test at least 6 months prior to the baseline/day 1 visit, or a liver biopsy performed prior to the baseline/day 1 visit with evidence of chronic hcv infection
Description

Hepatitis C, Chronic | Hepatitis C antibody test positive | Hepatitis C RNA positive | Hepatitis virus genotyping Positive | Biopsy of liver

Data type

boolean

Alias
UMLS CUI [1]
C0524910
UMLS CUI [2]
C1277805
UMLS CUI [3]
C0855842
UMLS CUI [4,1]
C2368162
UMLS CUI [4,2]
C1514241
UMLS CUI [5]
C0193388
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
current or prior history of any of the following:
Description

Criteria Any Fulfill

Data type

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1552551
UMLS CUI [1,3]
C1550543
clinically-significant illness cirrhosis 2. screening ecg with clinically significant abnormalities
Description

Illness Clinical Significance | Liver Cirrhosis | Electrocardiogram abnormal

Data type

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C2826293
UMLS CUI [2]
C0023890
UMLS CUI [3]
C0522055
1. alt > 10 x the upper limit of normal (uln)
Description

Alanine aminotransferase increased

Data type

boolean

Alias
UMLS CUI [1]
C0151905
2. ast > 10 x uln
Description

Aspartate aminotransferase increased

Data type

boolean

Alias
UMLS CUI [1]
C0151904
3. direct bilirubin > 1.5 x uln
Description

Direct bilirubin increased

Data type

boolean

Alias
UMLS CUI [1]
C0740434
4. platelets < 150,000/μl
Description

Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0032181
5. hba1c > 7.5%
Description

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
6. creatinine clearance (clcr) < 60 ml /min, as calculated by the cockcroft-gault equation
Description

Estimation of creatinine clearance by Cockcroft-Gault formula

Data type

boolean

Alias
UMLS CUI [1]
C2711451
7. hemoglobin < 11 g/dl for female subjects; < 12 g/dl for male subjects.
Description

Hemoglobin measurement | Gender

Data type

boolean

Alias
UMLS CUI [1]
C0518015
UMLS CUI [2]
C0079399
8. albumin < 3.1 g/dl
Description

Albumin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201838
9. inr > 1.5 x uln unless subject has known hemophilia or is stable on an anticoagulant regimen affecting inr 4. prior exposure to any approved or experimental hcv-specific direct-acting
Description

INR raised | Exception Hemophilia | Exception Anticoagulant therapy Stable | Exception Anticoagulant therapy Affecting INR | Exposure to DIRECT ACTING ANTIVIRALS HCV

Data type

boolean

Alias
UMLS CUI [1]
C0853225
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0684275
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0150457
UMLS CUI [3,3]
C0205360
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0150457
UMLS CUI [4,3]
C0392760
UMLS CUI [4,4]
C0525032
UMLS CUI [5,1]
C0332157
UMLS CUI [5,2]
C3653501
UMLS CUI [5,3]
C0220847
5. pregnant or nursing female or male with pregnant female partner.
Description

Pregnancy | Breast Feeding | Gender Partner Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0682323
UMLS CUI [3,3]
C0032961
6. chronic liver disease of a non-hcv etiology (e.g., hemochromatosis, wilson's disease, alfa-1 antitrypsin deficiency, cholangitis).
Description

Chronic liver disease | Etiology Except HCV | Hemochromatosis | Wilson's disease | alpha 1-Antitrypsin Deficiency | Cholangitis

Data type

boolean

Alias
UMLS CUI [1]
C0341439
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0332300
UMLS CUI [2,3]
C0220847
UMLS CUI [3]
C0018995
UMLS CUI [4]
C0019202
UMLS CUI [5]
C0221757
UMLS CUI [6]
C0008311
7. infection with hepatitis b virus (hbv) or human immunodeficiency virus (hiv).
Description

Hepatitis B | HIV Infection

Data type

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0019693
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Similar models

Eligibility Hepatitis C, Chronic NCT01994486

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
willing and able to provide informed consent
boolean
C0021430 (UMLS CUI [1])
Body mass index
Item
bmi (body mass index) ≥ 18 kg/m2
boolean
C1305855 (UMLS CUI [1])
Hepatitis C virus RNA assay
Item
hcv rna quantifiable at screening and >1,000 iu/ml
boolean
C1272251 (UMLS CUI [1])
Therapy naive HCV
Item
hcv treatment naïve
boolean
C0919936 (UMLS CUI [1,1])
C0220847 (UMLS CUI [1,2])
Hepatitis C virus genotype
Item
hcv genotype 1
boolean
C1533728 (UMLS CUI [1])
Hepatitis C, Chronic | Hepatitis C antibody test positive | Hepatitis C RNA positive | Hepatitis virus genotyping Positive | Biopsy of liver
Item
7. confirmation of chronic hcv infection documented by either: a positive anti-hcv antibody test or positive hcv rna or positive hcv genotyping test at least 6 months prior to the baseline/day 1 visit, or a liver biopsy performed prior to the baseline/day 1 visit with evidence of chronic hcv infection
boolean
C0524910 (UMLS CUI [1])
C1277805 (UMLS CUI [2])
C0855842 (UMLS CUI [3])
C2368162 (UMLS CUI [4,1])
C1514241 (UMLS CUI [4,2])
C0193388 (UMLS CUI [5])
Item Group
C0680251 (UMLS CUI)
Criteria Any Fulfill
Item
current or prior history of any of the following:
boolean
C0243161 (UMLS CUI [1,1])
C1552551 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
Illness Clinical Significance | Liver Cirrhosis | Electrocardiogram abnormal
Item
clinically-significant illness cirrhosis 2. screening ecg with clinically significant abnormalities
boolean
C0221423 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0023890 (UMLS CUI [2])
C0522055 (UMLS CUI [3])
Alanine aminotransferase increased
Item
1. alt > 10 x the upper limit of normal (uln)
boolean
C0151905 (UMLS CUI [1])
Aspartate aminotransferase increased
Item
2. ast > 10 x uln
boolean
C0151904 (UMLS CUI [1])
Direct bilirubin increased
Item
3. direct bilirubin > 1.5 x uln
boolean
C0740434 (UMLS CUI [1])
Platelet Count measurement
Item
4. platelets < 150,000/μl
boolean
C0032181 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
5. hba1c > 7.5%
boolean
C0474680 (UMLS CUI [1])
Estimation of creatinine clearance by Cockcroft-Gault formula
Item
6. creatinine clearance (clcr) < 60 ml /min, as calculated by the cockcroft-gault equation
boolean
C2711451 (UMLS CUI [1])
Hemoglobin measurement | Gender
Item
7. hemoglobin < 11 g/dl for female subjects; < 12 g/dl for male subjects.
boolean
C0518015 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Albumin measurement
Item
8. albumin < 3.1 g/dl
boolean
C0201838 (UMLS CUI [1])
INR raised | Exception Hemophilia | Exception Anticoagulant therapy Stable | Exception Anticoagulant therapy Affecting INR | Exposure to DIRECT ACTING ANTIVIRALS HCV
Item
9. inr > 1.5 x uln unless subject has known hemophilia or is stable on an anticoagulant regimen affecting inr 4. prior exposure to any approved or experimental hcv-specific direct-acting
boolean
C0853225 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0684275 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0150457 (UMLS CUI [3,2])
C0205360 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0150457 (UMLS CUI [4,2])
C0392760 (UMLS CUI [4,3])
C0525032 (UMLS CUI [4,4])
C0332157 (UMLS CUI [5,1])
C3653501 (UMLS CUI [5,2])
C0220847 (UMLS CUI [5,3])
Pregnancy | Breast Feeding | Gender Partner Pregnancy
Item
5. pregnant or nursing female or male with pregnant female partner.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0079399 (UMLS CUI [3,1])
C0682323 (UMLS CUI [3,2])
C0032961 (UMLS CUI [3,3])
Chronic liver disease | Etiology Except HCV | Hemochromatosis | Wilson's disease | alpha 1-Antitrypsin Deficiency | Cholangitis
Item
6. chronic liver disease of a non-hcv etiology (e.g., hemochromatosis, wilson's disease, alfa-1 antitrypsin deficiency, cholangitis).
boolean
C0341439 (UMLS CUI [1])
C0015127 (UMLS CUI [2,1])
C0332300 (UMLS CUI [2,2])
C0220847 (UMLS CUI [2,3])
C0018995 (UMLS CUI [3])
C0019202 (UMLS CUI [4])
C0221757 (UMLS CUI [5])
C0008311 (UMLS CUI [6])
Hepatitis B | HIV Infection
Item
7. infection with hepatitis b virus (hbv) or human immunodeficiency virus (hiv).
boolean
C0019163 (UMLS CUI [1])
C0019693 (UMLS CUI [2])
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