ID

36005

Description

Phase III Daclatasvir, Sofosbuvir, and Ribavirin in Cirrhotic Subjects and Subjects Post-liver Transplant; ODM derived from: https://clinicaltrials.gov/show/NCT02032875

Link

https://clinicaltrials.gov/show/NCT02032875

Keywords

Versions (1)
  1. 4/9/19 4/9/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 9, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatitis C NCT02032875

English

Eligibility Hepatitis C NCT02032875

1 forms  
Criteria
Description

Criteria

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects must be able to understand and agree to comply with the prescribed dosing regimens and procedures, report for regularly scheduled study visits, and reliably communicate with study personnel about adverse events and concomitant medications
Description

Protocol Compliance | Able to communicate Research Personnel

Data type

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2,1]
C2364293
UMLS CUI [2,2]
C0035173
subjects chronically infected with hcv genotype 1, 2, 3, 4, 5, or 6 with hcv rna viral load of ≥10,000 iu/ml at screening
Description

Chronic Hepatitis C Genotype | Hepatitis C virus RNA assay

Data type

boolean

Alias
UMLS CUI [1,1]
C0524910
UMLS CUI [1,2]
C1285573
UMLS CUI [2]
C1272251
subjects may be treatment-naïve or treatment-experienced
Description

Therapy naive | Treatment Experience

Data type

boolean

Alias
UMLS CUI [1]
C0919936
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0596545
cirrhotic subjects must have cirrhosis confirmed by biopsy, fibroscan or fibrotest and aspartate aminotransferase platelet ratio index (apri) criteria as outlined in the protocol
Description

Liver Cirrhosis Biopsy | Liver Cirrhosis Fibroscan | Liver Cirrhosis FibroTest Score Measurement | Liver Cirrhosis AST to platelet ratio index Criteria

Data type

boolean

Alias
UMLS CUI [1,1]
C0023890
UMLS CUI [1,2]
C0005558
UMLS CUI [2,1]
C0023890
UMLS CUI [2,2]
C4522043
UMLS CUI [3,1]
C0023890
UMLS CUI [3,2]
C3642160
UMLS CUI [4,1]
C0023890
UMLS CUI [4,2]
C4483916
UMLS CUI [4,3]
C0243161
post-transplant subjects must be at least 3 months post-transplant with no evidence of moderate or severe rejection
Description

Study Subject Post Transplantation | Moderate cellular graft rejection Absent | Severe cellular graft rejection Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0687676
UMLS CUI [1,3]
C0040732
UMLS CUI [2,1]
C0312824
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0301946
UMLS CUI [3,2]
C0332197
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of multi-organ transplant, with the exception of dual transplantation of the liver/kidney, is prohibited
Description

Organ Transplantation multiple | Exception Transplantation Liver Kidney

Data type

boolean

Alias
UMLS CUI [1,1]
C0029216
UMLS CUI [1,2]
C0439064
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0040732
UMLS CUI [2,3]
C0545792
current or known history of cancer (with the following exceptions: in situ carcinoma of the cervix, adequately treated basal or squamous cell carcinoma of the skin, or hepatocellular carcinoma within milan criteria for transplantation) within 5 years prior to screening
Description

Malignant Neoplasms | Exception Carcinoma in situ of uterine cervix | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Liver carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0851140
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007117
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0553723
UMLS CUI [4,3]
C1522326
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C2239176
evidence of an ongoing medical condition contributing to chronic liver disease other than hcv (such as, but not limited to: hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, or toxin exposures)
Description

Medical condition Contributing Chronic liver disease | Exception Hepatitis C virus | Hemochromatosis | Hepatitis, Autoimmune | Liver disease Metabolic | Alcoholic Liver Disease | Exposure to toxin

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C1880177
UMLS CUI [1,3]
C0341439
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0220847
UMLS CUI [3]
C0018995
UMLS CUI [4]
C0241910
UMLS CUI [5,1]
C0023895
UMLS CUI [5,2]
C0311400
UMLS CUI [6]
C0023896
UMLS CUI [7]
C0040537
history of hiv infection or chronic hepatitis b virus (hbv) as documented by hbv serologies (e.g., hbsag-seropositive). subjects with resolved hbv infection may participate (e.g., hbcab-seropositive with concurrent hbsag-seronegative)
Description

HIV Infection | Chronic Hepatitis B Hepatitis B Serology | Hepatitis B Surface Antigens Seropositive | Hepatitis B resolved allowed

Data type

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2,1]
C0524909
UMLS CUI [2,2]
C0744837
UMLS CUI [3,1]
C0019168
UMLS CUI [3,2]
C0521143
UMLS CUI [4,1]
C0019163
UMLS CUI [4,2]
C1514893
UMLS CUI [4,3]
C0683607
active hospitalization for decompensated liver disease
Description

Hospitalization Decompensated liver disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C4075847
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Similar models

Eligibility Hepatitis C NCT02032875

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Item Group
C1512693 (UMLS CUI)
Protocol Compliance | Able to communicate Research Personnel
Item
subjects must be able to understand and agree to comply with the prescribed dosing regimens and procedures, report for regularly scheduled study visits, and reliably communicate with study personnel about adverse events and concomitant medications
boolean
C0525058 (UMLS CUI [1])
C2364293 (UMLS CUI [2,1])
C0035173 (UMLS CUI [2,2])
Chronic Hepatitis C Genotype | Hepatitis C virus RNA assay
Item
subjects chronically infected with hcv genotype 1, 2, 3, 4, 5, or 6 with hcv rna viral load of ≥10,000 iu/ml at screening
boolean
C0524910 (UMLS CUI [1,1])
C1285573 (UMLS CUI [1,2])
C1272251 (UMLS CUI [2])
Therapy naive | Treatment Experience
Item
subjects may be treatment-naïve or treatment-experienced
boolean
C0919936 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0596545 (UMLS CUI [2,2])
Liver Cirrhosis Biopsy | Liver Cirrhosis Fibroscan | Liver Cirrhosis FibroTest Score Measurement | Liver Cirrhosis AST to platelet ratio index Criteria
Item
cirrhotic subjects must have cirrhosis confirmed by biopsy, fibroscan or fibrotest and aspartate aminotransferase platelet ratio index (apri) criteria as outlined in the protocol
boolean
C0023890 (UMLS CUI [1,1])
C0005558 (UMLS CUI [1,2])
C0023890 (UMLS CUI [2,1])
C4522043 (UMLS CUI [2,2])
C0023890 (UMLS CUI [3,1])
C3642160 (UMLS CUI [3,2])
C0023890 (UMLS CUI [4,1])
C4483916 (UMLS CUI [4,2])
C0243161 (UMLS CUI [4,3])
Study Subject Post Transplantation | Moderate cellular graft rejection Absent | Severe cellular graft rejection Absent
Item
post-transplant subjects must be at least 3 months post-transplant with no evidence of moderate or severe rejection
boolean
C0681850 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
C0040732 (UMLS CUI [1,3])
C0312824 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0301946 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Organ Transplantation multiple | Exception Transplantation Liver Kidney
Item
history of multi-organ transplant, with the exception of dual transplantation of the liver/kidney, is prohibited
boolean
C0029216 (UMLS CUI [1,1])
C0439064 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0040732 (UMLS CUI [2,2])
C0545792 (UMLS CUI [2,3])
Malignant Neoplasms | Exception Carcinoma in situ of uterine cervix | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Liver carcinoma
Item
current or known history of cancer (with the following exceptions: in situ carcinoma of the cervix, adequately treated basal or squamous cell carcinoma of the skin, or hepatocellular carcinoma within milan criteria for transplantation) within 5 years prior to screening
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0851140 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0553723 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C2239176 (UMLS CUI [5,2])
Medical condition Contributing Chronic liver disease | Exception Hepatitis C virus | Hemochromatosis | Hepatitis, Autoimmune | Liver disease Metabolic | Alcoholic Liver Disease | Exposure to toxin
Item
evidence of an ongoing medical condition contributing to chronic liver disease other than hcv (such as, but not limited to: hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, or toxin exposures)
boolean
C3843040 (UMLS CUI [1,1])
C1880177 (UMLS CUI [1,2])
C0341439 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0220847 (UMLS CUI [2,2])
C0018995 (UMLS CUI [3])
C0241910 (UMLS CUI [4])
C0023895 (UMLS CUI [5,1])
C0311400 (UMLS CUI [5,2])
C0023896 (UMLS CUI [6])
C0040537 (UMLS CUI [7])
HIV Infection | Chronic Hepatitis B Hepatitis B Serology | Hepatitis B Surface Antigens Seropositive | Hepatitis B resolved allowed
Item
history of hiv infection or chronic hepatitis b virus (hbv) as documented by hbv serologies (e.g., hbsag-seropositive). subjects with resolved hbv infection may participate (e.g., hbcab-seropositive with concurrent hbsag-seronegative)
boolean
C0019693 (UMLS CUI [1])
C0524909 (UMLS CUI [2,1])
C0744837 (UMLS CUI [2,2])
C0019168 (UMLS CUI [3,1])
C0521143 (UMLS CUI [3,2])
C0019163 (UMLS CUI [4,1])
C1514893 (UMLS CUI [4,2])
C0683607 (UMLS CUI [4,3])
Hospitalization Decompensated liver disease
Item
active hospitalization for decompensated liver disease
boolean
C0019993 (UMLS CUI [1,1])
C4075847 (UMLS CUI [1,2])
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