ID

36037

Description

Reversal of Hepatic Impairment in Patients With Hepatitis C Virus (HCV) and Early Decompensation of Cirrhosis; ODM derived from: https://clinicaltrials.gov/show/NCT02455167

Link

https://clinicaltrials.gov/show/NCT02455167

Keywords

Versions (1)
  1. 4/10/19 4/10/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 10, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatitis C NCT02455167

English

Eligibility Hepatitis C NCT02455167

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. hcv genotype 1 infection (all subtypes and q80k a type of mutation are allowed), and have been approved by a third party payer for the fda-approved combination of sofosbuvir (sof) plus ribavirin. the study drug, simeprevir (smv)
Description

Hepatitis C Genotype Subtype All | Other Coding | Combined Modality Therapy | sofosbuvir | Ribavirin | simeprevir

Data type

boolean

Alias
UMLS CUI [1,1]
C0019196
UMLS CUI [1,2]
C1285573
UMLS CUI [1,3]
C0449560
UMLS CUI [1,4]
C0444868
UMLS CUI [2]
C3846158
UMLS CUI [3]
C0009429
UMLS CUI [4]
C2976303
UMLS CUI [5]
C0035525
UMLS CUI [6]
C2605855
2. biopsy proven cirrhosis, or clinical cirrhosis with apri (ast to platelet ratio index to determine clinical cirrhosis)> 2, fibrotest > 0.75, or fibroscan > 12.5 results stiffness (kpa).
Description

Liver Cirrhosis | Biopsy of liver | AST to platelet ratio index | FibroTest Score Measurement | Fibroscan | Result Liver Stiffness

Data type

boolean

Alias
UMLS CUI [1]
C0023890
UMLS CUI [2]
C0193388
UMLS CUI [3]
C4483916
UMLS CUI [4]
C3642160
UMLS CUI [5]
C4522043
UMLS CUI [6,1]
C1274040
UMLS CUI [6,2]
C4034374
3. meld 10 or less
Description

MELD score

Data type

boolean

Alias
UMLS CUI [1]
C4048785
4. expected survival without liver transplantation of >1 year
Description

Life Expectancy | Transplantation of liver Absent

Data type

boolean

Alias
UMLS CUI [1]
C0023671
UMLS CUI [2,1]
C0023911
UMLS CUI [2,2]
C0332197
5. patients with hepatocellular carcinoma (hcc) are included as long as disease meld is 10 or less, and anticipated time to transplant is >1 year. an example, might be a patient with a subcentimeter hcc who is undergoing serial imaging to document tumor growth to tumor diameter >2 cm prior to listing for transplantation (in order to secure meld exception). in this case, there could be a time lapse of 3 months or more while monitoring tumor growth, and a further time lapse of 9 months or more until the time of transplantation.
Description

Liver carcinoma | MELD score | Serial imaging | Tumor Diameter | Transplantation Anticipated

Data type

boolean

Alias
UMLS CUI [1]
C2239176
UMLS CUI [2]
C4048785
UMLS CUI [3]
C0203640
UMLS CUI [4,1]
C0027651
UMLS CUI [4,2]
C1301886
UMLS CUI [5,1]
C0040732
UMLS CUI [5,2]
C3840775
6. patients with tips or portal vein thrombosis may be included. -
Description

TIPS | Portal vein thrombosis

Data type

boolean

Alias
UMLS CUI [1]
C0339897
UMLS CUI [2]
C0155773
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. inability to provide informed consent
Description

Informed Consent Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
2. known hypersensitivity or serious adverse reaction to any of the study drugs
Description

Hypersensitivity Investigational New Drugs | Adverse reactions Serious Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0559546
UMLS CUI [2,2]
C0205404
UMLS CUI [2,3]
C0013230
3. age <18 or >80 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
4. pregnancy as determined by subject reporting and urine dipstick testing at screening.
Description

Pregnancy Patient Self-Report | Pregnancy Urine dipstick test

Data type

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0681906
UMLS CUI [2,1]
C0032961
UMLS CUI [2,2]
C0430370
5. other underlying chronic liver disease - examples that would exclude a patient from participating include but are not limited to nonalcoholic liver disease, alcoholic liver disease, hepatitis b, hemochromatosis, and autoimmune liver disease.
Description

Chronic liver disease | Chronic nonalcoholic liver disease | Alcoholic Liver Diseases | Hepatitis B | Hemochromatosis | Autoimmune liver disease

Data type

boolean

Alias
UMLS CUI [1]
C0341439
UMLS CUI [2]
C0221388
UMLS CUI [3]
C0023896
UMLS CUI [4]
C0019163
UMLS CUI [5]
C0018995
UMLS CUI [6]
C0400936
6. serious other underlying medical condition - examples include but are not limited to unstable cardiovascular, coronary, or pulmonary disease including right and left sided heart failure, active malignancy other than hcc, or serious infection.
Description

Medical condition Serious | Cardiovascular Disease Unstable | Coronary Artery Disease Unstable | Lung disease Unstable | Heart Failure, Right-Sided | Left-Sided Heart Failure | Malignant Neoplasms | Exception Liver carcinoma | Communicable Disease Serious

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C0007222
UMLS CUI [2,2]
C0443343
UMLS CUI [3,1]
C1956346
UMLS CUI [3,2]
C0443343
UMLS CUI [4,1]
C0024115
UMLS CUI [4,2]
C0443343
UMLS CUI [5]
C0235527
UMLS CUI [6]
C0023212
UMLS CUI [7]
C0006826
UMLS CUI [8,1]
C1705847
UMLS CUI [8,2]
C2239176
UMLS CUI [9,1]
C0009450
UMLS CUI [9,2]
C0205404
7. estimated creatinine clearance < 30 ml min-1 1.73 m2 surface area (bsa)
Description

Estimation of creatinine clearance by Cockcroft-Gault formula | Body Surface Area

Data type

boolean

Alias
UMLS CUI [1]
C2711451
UMLS CUI [2]
C0005902
8. hemoglobin <10 g/dl
Description

Hemoglobin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0518015
9. neutrophils <500 /μl
Description

Neutrophil count

Data type

boolean

Alias
UMLS CUI [1]
C0200633
10. platelets <50,000 /μl
Description

Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0032181
11. bilirubin >4 mg/dl
Description

Serum total bilirubin measurement

Data type

boolean

Alias
UMLS CUI [1]
C1278039
12. albumin < 2.8 g/dl
Description

Albumin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201838
13. blood clotting: international normalised ratio (inr) > 2
Description

Blood coagulation | International Normalized Ratio

Data type

boolean

Alias
UMLS CUI [1]
C0005778
UMLS CUI [2]
C0525032
14. meld >10
Description

MELD score

Data type

boolean

Alias
UMLS CUI [1]
C4048785
15. child-turcotte-pugh class b or c; or, ctp score >7
Description

Child-Pugh-Turcotte score

Data type

boolean

Alias
UMLS CUI [1]
C3854424
16. conditions that would affect the absorption of orally administered cholate used in the hepquant® test - such as, extensive intestinal resection, diabetic gastroparesis, and ileal disease or resection.
Description

Condition Affecting Absorption Cholate | Liver Function Tests | Intestinal resection Extensive | Gastroparesis due to diabetes mellitus | Ileal Diseases | Ileectomy

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0237442
UMLS CUI [1,4]
C0109497
UMLS CUI [2]
C0023901
UMLS CUI [3,1]
C1096244
UMLS CUI [3,2]
C0205231
UMLS CUI [4]
C0267176
UMLS CUI [5]
C0020875
UMLS CUI [6]
C0399935
17. concomitant use of both beta-blocker and ace inhibitor
Description

Adrenergic beta-Antagonists | Angiotensin-Converting Enzyme Inhibitors

Data type

boolean

Alias
UMLS CUI [1]
C0001645
UMLS CUI [2]
C0003015
18. subjects taking any other medications with significant drug drug interactions related to the study medications (sofosbuvir, simeprevir, or ribavirin) who cannot discontinue or substitute that medication, will be excluded.
Description

Pharmaceutical Preparations Drug Interactions Investigational New Drugs | sofosbuvir | simeprevir | Ribavirin | Pharmaceutical Preparations Discontinue Unsuccessful

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0687133
UMLS CUI [1,3]
C0013230
UMLS CUI [2]
C2976303
UMLS CUI [3]
C2605855
UMLS CUI [4]
C0035525
UMLS CUI [5,1]
C0013227
UMLS CUI [5,2]
C1444662
UMLS CUI [5,3]
C1272705
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Similar models

Eligibility Hepatitis C NCT02455167

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Hepatitis C Genotype Subtype All | Other Coding | Combined Modality Therapy | sofosbuvir | Ribavirin | simeprevir
Item
1. hcv genotype 1 infection (all subtypes and q80k a type of mutation are allowed), and have been approved by a third party payer for the fda-approved combination of sofosbuvir (sof) plus ribavirin. the study drug, simeprevir (smv)
boolean
C0019196 (UMLS CUI [1,1])
C1285573 (UMLS CUI [1,2])
C0449560 (UMLS CUI [1,3])
C0444868 (UMLS CUI [1,4])
C3846158 (UMLS CUI [2])
C0009429 (UMLS CUI [3])
C2976303 (UMLS CUI [4])
C0035525 (UMLS CUI [5])
C2605855 (UMLS CUI [6])
Liver Cirrhosis | Biopsy of liver | AST to platelet ratio index | FibroTest Score Measurement | Fibroscan | Result Liver Stiffness
Item
2. biopsy proven cirrhosis, or clinical cirrhosis with apri (ast to platelet ratio index to determine clinical cirrhosis)> 2, fibrotest > 0.75, or fibroscan > 12.5 results stiffness (kpa).
boolean
C0023890 (UMLS CUI [1])
C0193388 (UMLS CUI [2])
C4483916 (UMLS CUI [3])
C3642160 (UMLS CUI [4])
C4522043 (UMLS CUI [5])
C1274040 (UMLS CUI [6,1])
C4034374 (UMLS CUI [6,2])
MELD score
Item
3. meld 10 or less
boolean
C4048785 (UMLS CUI [1])
Life Expectancy | Transplantation of liver Absent
Item
4. expected survival without liver transplantation of >1 year
boolean
C0023671 (UMLS CUI [1])
C0023911 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Liver carcinoma | MELD score | Serial imaging | Tumor Diameter | Transplantation Anticipated
Item
5. patients with hepatocellular carcinoma (hcc) are included as long as disease meld is 10 or less, and anticipated time to transplant is >1 year. an example, might be a patient with a subcentimeter hcc who is undergoing serial imaging to document tumor growth to tumor diameter >2 cm prior to listing for transplantation (in order to secure meld exception). in this case, there could be a time lapse of 3 months or more while monitoring tumor growth, and a further time lapse of 9 months or more until the time of transplantation.
boolean
C2239176 (UMLS CUI [1])
C4048785 (UMLS CUI [2])
C0203640 (UMLS CUI [3])
C0027651 (UMLS CUI [4,1])
C1301886 (UMLS CUI [4,2])
C0040732 (UMLS CUI [5,1])
C3840775 (UMLS CUI [5,2])
TIPS | Portal vein thrombosis
Item
6. patients with tips or portal vein thrombosis may be included. -
boolean
C0339897 (UMLS CUI [1])
C0155773 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Informed Consent Unable
Item
1. inability to provide informed consent
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Hypersensitivity Investigational New Drugs | Adverse reactions Serious Investigational New Drugs
Item
2. known hypersensitivity or serious adverse reaction to any of the study drugs
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0559546 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0013230 (UMLS CUI [2,3])
Age
Item
3. age <18 or >80 years
boolean
C0001779 (UMLS CUI [1])
Pregnancy Patient Self-Report | Pregnancy Urine dipstick test
Item
4. pregnancy as determined by subject reporting and urine dipstick testing at screening.
boolean
C0032961 (UMLS CUI [1,1])
C0681906 (UMLS CUI [1,2])
C0032961 (UMLS CUI [2,1])
C0430370 (UMLS CUI [2,2])
Chronic liver disease | Chronic nonalcoholic liver disease | Alcoholic Liver Diseases | Hepatitis B | Hemochromatosis | Autoimmune liver disease
Item
5. other underlying chronic liver disease - examples that would exclude a patient from participating include but are not limited to nonalcoholic liver disease, alcoholic liver disease, hepatitis b, hemochromatosis, and autoimmune liver disease.
boolean
C0341439 (UMLS CUI [1])
C0221388 (UMLS CUI [2])
C0023896 (UMLS CUI [3])
C0019163 (UMLS CUI [4])
C0018995 (UMLS CUI [5])
C0400936 (UMLS CUI [6])
Medical condition Serious | Cardiovascular Disease Unstable | Coronary Artery Disease Unstable | Lung disease Unstable | Heart Failure, Right-Sided | Left-Sided Heart Failure | Malignant Neoplasms | Exception Liver carcinoma | Communicable Disease Serious
Item
6. serious other underlying medical condition - examples include but are not limited to unstable cardiovascular, coronary, or pulmonary disease including right and left sided heart failure, active malignancy other than hcc, or serious infection.
boolean
C3843040 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0007222 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
C1956346 (UMLS CUI [3,1])
C0443343 (UMLS CUI [3,2])
C0024115 (UMLS CUI [4,1])
C0443343 (UMLS CUI [4,2])
C0235527 (UMLS CUI [5])
C0023212 (UMLS CUI [6])
C0006826 (UMLS CUI [7])
C1705847 (UMLS CUI [8,1])
C2239176 (UMLS CUI [8,2])
C0009450 (UMLS CUI [9,1])
C0205404 (UMLS CUI [9,2])
Estimation of creatinine clearance by Cockcroft-Gault formula | Body Surface Area
Item
7. estimated creatinine clearance < 30 ml min-1 1.73 m2 surface area (bsa)
boolean
C2711451 (UMLS CUI [1])
C0005902 (UMLS CUI [2])
Hemoglobin measurement
Item
8. hemoglobin <10 g/dl
boolean
C0518015 (UMLS CUI [1])
Neutrophil count
Item
9. neutrophils <500 /μl
boolean
C0200633 (UMLS CUI [1])
Platelet Count measurement
Item
10. platelets <50,000 /μl
boolean
C0032181 (UMLS CUI [1])
Serum total bilirubin measurement
Item
11. bilirubin >4 mg/dl
boolean
C1278039 (UMLS CUI [1])
Albumin measurement
Item
12. albumin < 2.8 g/dl
boolean
C0201838 (UMLS CUI [1])
Blood coagulation | International Normalized Ratio
Item
13. blood clotting: international normalised ratio (inr) > 2
boolean
C0005778 (UMLS CUI [1])
C0525032 (UMLS CUI [2])
MELD score
Item
14. meld >10
boolean
C4048785 (UMLS CUI [1])
Child-Pugh-Turcotte score
Item
15. child-turcotte-pugh class b or c; or, ctp score >7
boolean
C3854424 (UMLS CUI [1])
Condition Affecting Absorption Cholate | Liver Function Tests | Intestinal resection Extensive | Gastroparesis due to diabetes mellitus | Ileal Diseases | Ileectomy
Item
16. conditions that would affect the absorption of orally administered cholate used in the hepquant® test - such as, extensive intestinal resection, diabetic gastroparesis, and ileal disease or resection.
boolean
C0348080 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0237442 (UMLS CUI [1,3])
C0109497 (UMLS CUI [1,4])
C0023901 (UMLS CUI [2])
C1096244 (UMLS CUI [3,1])
C0205231 (UMLS CUI [3,2])
C0267176 (UMLS CUI [4])
C0020875 (UMLS CUI [5])
C0399935 (UMLS CUI [6])
Adrenergic beta-Antagonists | Angiotensin-Converting Enzyme Inhibitors
Item
17. concomitant use of both beta-blocker and ace inhibitor
boolean
C0001645 (UMLS CUI [1])
C0003015 (UMLS CUI [2])
Pharmaceutical Preparations Drug Interactions Investigational New Drugs | sofosbuvir | simeprevir | Ribavirin | Pharmaceutical Preparations Discontinue Unsuccessful
Item
18. subjects taking any other medications with significant drug drug interactions related to the study medications (sofosbuvir, simeprevir, or ribavirin) who cannot discontinue or substitute that medication, will be excluded.
boolean
C0013227 (UMLS CUI [1,1])
C0687133 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,3])
C2976303 (UMLS CUI [2])
C2605855 (UMLS CUI [3])
C0035525 (UMLS CUI [4])
C0013227 (UMLS CUI [5,1])
C1444662 (UMLS CUI [5,2])
C1272705 (UMLS CUI [5,3])
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