ID

39611

Description

Study in Hepatitis C Virus (HCV) Infected Patients Undergoing Liver Transplantation to Evaluate a Human Monoclonal Antibody Against Hepatitis C; ODM derived from: https://clinicaltrials.gov/show/NCT01121185

Link

https://clinicaltrials.gov/show/NCT01121185

Keywords

Versions (1)
  1. 2/3/20 2/3/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 3, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility HCV Infection NCT01121185

English

Eligibility HCV Infection NCT01121185

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient ≥ 18 years of age with documented chronic hepatitis c virus infection of genotype 1a undergoing liver transplantation from either a deceased donor or living donor.
Description

Age | Chronic Hepatitis C Genotype | Transplantation of liver Cadaver donor | Transplantation of liver Living Donor

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0524910
UMLS CUI [2,2]
C1533728
UMLS CUI [3,1]
C0023911
UMLS CUI [3,2]
C0524354
UMLS CUI [4,1]
C0023911
UMLS CUI [4,2]
C0348050
patient or legal guardian/health care proxy must have read, understood and provided written informed consent and hipaa authorization after the nature of the study has been fully explained.
Description

Informed Consent | Informed Consent Guardian | Informed Consent Patient Representative

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C1274041
UMLS CUI [3,1]
C0021430
UMLS CUI [3,2]
C0030701
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
positive serology for hepatitis b surface antigen
Description

Serology positive Hepatitis B Surface Antigens

Data type

boolean

Alias
UMLS CUI [1,1]
C0242089
UMLS CUI [1,2]
C0019168
positive serology for hiv
Description

HIV Seropositivity

Data type

boolean

Alias
UMLS CUI [1]
C0019699
pregnancy or breastfeeding
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
previous history of any organ transplant
Description

Organ Transplantation

Data type

boolean

Alias
UMLS CUI [1]
C0029216
planned receipt of combined organ transplant (e.g. liver and kidney)
Description

Organ Transplantation Combined Planned | Liver Kidney Transplantation

Data type

boolean

Alias
UMLS CUI [1,1]
C0029216
UMLS CUI [1,2]
C0205195
UMLS CUI [1,3]
C1301732
UMLS CUI [2,1]
C0023884
UMLS CUI [2,2]
C0022646
UMLS CUI [2,3]
C0040732
receipt or planned receipt of immune globulin (ivig) within 90 days of enrollment
Description

Immunoglobulin, Intravenous | Intravenous Immunoglobulin Planned

Data type

boolean

Alias
UMLS CUI [1]
C0085297
UMLS CUI [2,1]
C0085297
UMLS CUI [2,2]
C1301732
history of extrahepatic malignancy and/or receiving chemotherapy within 90 days prior to enrollment with the exception of chemoembolization for hepatocellular carcinoma
Description

Malignant Neoplasms Extrahepatic | Chemotherapy | Exception Chemoembolization Liver carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C1517058
UMLS CUI [2]
C0392920
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0796679
UMLS CUI [3,3]
C2239176
hepatocellular carcinoma with tumor burden outside of the milan criteria
Description

Liver carcinoma | Tumor Burden | Criteria Specified failed

Data type

boolean

Alias
UMLS CUI [1]
C2239176
UMLS CUI [2]
C1449699
UMLS CUI [3,1]
C0243161
UMLS CUI [3,2]
C0205369
UMLS CUI [3,3]
C0231175
history of chronic renal insufficiency or creatinine > 2.5 for ≥ six months
Description

Chronic Kidney Insufficiency | Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0403447
UMLS CUI [2]
C0201976
personal or family history of deep venous thrombosis or pulmonary embolism
Description

History of Deep vein thrombosis | Family history Deep Vein Thrombosis | Personal history of pulmonary embolism | Family history of pulmonary embolism

Data type

boolean

Alias
UMLS CUI [1]
C0459853
UMLS CUI [2,1]
C0241889
UMLS CUI [2,2]
C0149871
UMLS CUI [3]
C0585968
UMLS CUI [4]
C2317597
receipt of liver allograft from hcv positive donor or hepatitis b core antibody positive donor
Description

Allograft liver Recipient | Donor Hepatitis C Virus Positive | Donor Hepatitis B core antibody positive

Data type

boolean

Alias
UMLS CUI [1,1]
C1720451
UMLS CUI [1,2]
C1709854
UMLS CUI [2,1]
C0029206
UMLS CUI [2,2]
C4330254
UMLS CUI [3,1]
C0029206
UMLS CUI [3,2]
C0262506
receipt of liver allograft donated after cardiac death of donor
Description

Allograft liver Recipient | Status post Cardiac Death Donor

Data type

boolean

Alias
UMLS CUI [1,1]
C1720451
UMLS CUI [1,2]
C1709854
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C0376297
UMLS CUI [2,3]
C0029206
receipt of any antiviral agents, licensed or investigational for hepatitis c virus within 90 days prior to enrollment
Description

Antiviral Agents Hepatitis C virus | Antiviral Agents Investigational Hepatitis C virus

Data type

boolean

Alias
UMLS CUI [1,1]
C0003451
UMLS CUI [1,2]
C0220847
UMLS CUI [2,1]
C0003451
UMLS CUI [2,2]
C1517586
UMLS CUI [2,3]
C0220847
receipt of any other investigational study product within 30 days prior to enrollment
Description

Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013230
any other condition that in the opinion of the investigator would jeopardize the safety or rights of the patient participating in the study or make it unlikely that the patient could complete the study
Description

Condition compromises Patient safety | Condition compromises Patient Rights | Patient condition Completion of clinical trial Unlikely

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C2945640
UMLS CUI [1,3]
C1113679
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C2945640
UMLS CUI [2,3]
C0030706
UMLS CUI [3,1]
C0683521
UMLS CUI [3,2]
C2732579
UMLS CUI [3,3]
C0750558
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Similar models

Eligibility HCV Infection NCT01121185

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age | Chronic Hepatitis C Genotype | Transplantation of liver Cadaver donor | Transplantation of liver Living Donor
Item
patient ≥ 18 years of age with documented chronic hepatitis c virus infection of genotype 1a undergoing liver transplantation from either a deceased donor or living donor.
boolean
C0001779 (UMLS CUI [1])
C0524910 (UMLS CUI [2,1])
C1533728 (UMLS CUI [2,2])
C0023911 (UMLS CUI [3,1])
C0524354 (UMLS CUI [3,2])
C0023911 (UMLS CUI [4,1])
C0348050 (UMLS CUI [4,2])
Informed Consent | Informed Consent Guardian | Informed Consent Patient Representative
Item
patient or legal guardian/health care proxy must have read, understood and provided written informed consent and hipaa authorization after the nature of the study has been fully explained.
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C1274041 (UMLS CUI [2,2])
C0021430 (UMLS CUI [3,1])
C0030701 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Serology positive Hepatitis B Surface Antigens
Item
positive serology for hepatitis b surface antigen
boolean
C0242089 (UMLS CUI [1,1])
C0019168 (UMLS CUI [1,2])
HIV Seropositivity
Item
positive serology for hiv
boolean
C0019699 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnancy or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Organ Transplantation
Item
previous history of any organ transplant
boolean
C0029216 (UMLS CUI [1])
Organ Transplantation Combined Planned | Liver Kidney Transplantation
Item
planned receipt of combined organ transplant (e.g. liver and kidney)
boolean
C0029216 (UMLS CUI [1,1])
C0205195 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
C0023884 (UMLS CUI [2,1])
C0022646 (UMLS CUI [2,2])
C0040732 (UMLS CUI [2,3])
Immunoglobulin, Intravenous | Intravenous Immunoglobulin Planned
Item
receipt or planned receipt of immune globulin (ivig) within 90 days of enrollment
boolean
C0085297 (UMLS CUI [1])
C0085297 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
Malignant Neoplasms Extrahepatic | Chemotherapy | Exception Chemoembolization Liver carcinoma
Item
history of extrahepatic malignancy and/or receiving chemotherapy within 90 days prior to enrollment with the exception of chemoembolization for hepatocellular carcinoma
boolean
C0006826 (UMLS CUI [1,1])
C1517058 (UMLS CUI [1,2])
C0392920 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0796679 (UMLS CUI [3,2])
C2239176 (UMLS CUI [3,3])
Liver carcinoma | Tumor Burden | Criteria Specified failed
Item
hepatocellular carcinoma with tumor burden outside of the milan criteria
boolean
C2239176 (UMLS CUI [1])
C1449699 (UMLS CUI [2])
C0243161 (UMLS CUI [3,1])
C0205369 (UMLS CUI [3,2])
C0231175 (UMLS CUI [3,3])
Chronic Kidney Insufficiency | Creatinine measurement, serum
Item
history of chronic renal insufficiency or creatinine > 2.5 for ≥ six months
boolean
C0403447 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
History of Deep vein thrombosis | Family history Deep Vein Thrombosis | Personal history of pulmonary embolism | Family history of pulmonary embolism
Item
personal or family history of deep venous thrombosis or pulmonary embolism
boolean
C0459853 (UMLS CUI [1])
C0241889 (UMLS CUI [2,1])
C0149871 (UMLS CUI [2,2])
C0585968 (UMLS CUI [3])
C2317597 (UMLS CUI [4])
Allograft liver Recipient | Donor Hepatitis C Virus Positive | Donor Hepatitis B core antibody positive
Item
receipt of liver allograft from hcv positive donor or hepatitis b core antibody positive donor
boolean
C1720451 (UMLS CUI [1,1])
C1709854 (UMLS CUI [1,2])
C0029206 (UMLS CUI [2,1])
C4330254 (UMLS CUI [2,2])
C0029206 (UMLS CUI [3,1])
C0262506 (UMLS CUI [3,2])
Allograft liver Recipient | Status post Cardiac Death Donor
Item
receipt of liver allograft donated after cardiac death of donor
boolean
C1720451 (UMLS CUI [1,1])
C1709854 (UMLS CUI [1,2])
C0231290 (UMLS CUI [2,1])
C0376297 (UMLS CUI [2,2])
C0029206 (UMLS CUI [2,3])
Antiviral Agents Hepatitis C virus | Antiviral Agents Investigational Hepatitis C virus
Item
receipt of any antiviral agents, licensed or investigational for hepatitis c virus within 90 days prior to enrollment
boolean
C0003451 (UMLS CUI [1,1])
C0220847 (UMLS CUI [1,2])
C0003451 (UMLS CUI [2,1])
C1517586 (UMLS CUI [2,2])
C0220847 (UMLS CUI [2,3])
Investigational New Drugs
Item
receipt of any other investigational study product within 30 days prior to enrollment
boolean
C0013230 (UMLS CUI [1])
Condition compromises Patient safety | Condition compromises Patient Rights | Patient condition Completion of clinical trial Unlikely
Item
any other condition that in the opinion of the investigator would jeopardize the safety or rights of the patient participating in the study or make it unlikely that the patient could complete the study
boolean
C0348080 (UMLS CUI [1,1])
C2945640 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C2945640 (UMLS CUI [2,2])
C0030706 (UMLS CUI [2,3])
C0683521 (UMLS CUI [3,1])
C2732579 (UMLS CUI [3,2])
C0750558 (UMLS CUI [3,3])
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