ID

40907

Description

Open Label Study of the Efficacy and Safety of MBL-HCV1 in Combination With Oral Direct-Acting Antivirals in Patients Undergoing Liver Transplantation for Hepatitis C; ODM derived from: https://clinicaltrials.gov/show/NCT01532908

Link

https://clinicaltrials.gov/show/NCT01532908

Keywords

Versions (1)
  1. 6/2/20 6/2/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 2, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatitis C Infection NCT01532908

English

Eligibility Hepatitis C Infection NCT01532908

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 1 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]
C1285573
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 Legal Guardian

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0023226
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
positive for hepatitis b surface antigen
Description

Hepatitis B surface antigen positive

Data type

boolean

Alias
UMLS CUI [1]
C0149709
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 | Transplantation of 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]
C0023911
UMLS CUI [3]
C0022671
receipt or planned receipt of immune globulin (ivig) within 90 days of enrollment
Description

Immunoglobulins, Intravenous | Intravenous Immunoglobulins Planned

Data type

boolean

Alias
UMLS CUI [1]
C0085297
UMLS CUI [2,1]
C0085297
UMLS CUI [2,2]
C1301732
extrahepatic malignancy not currently in remission and/or receiving systemic chemotherapy and/or radiation within 90 days prior to enrollment. exceptions include chemoembolization for hepatocellular carcinoma or cutaneous malignancies managed with local treatment
Description

Malignant Neoplasm Extrahepatic | Remission Absent | Systemic Chemotherapy | Systemic Radiation Therapy | Exception Chemoembolization Liver carcinoma | Exception Local Therapy Skin carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C1517058
UMLS CUI [2,1]
C0687702
UMLS CUI [2,2]
C0332197
UMLS CUI [3]
C1883256
UMLS CUI [4]
C2985381
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0796679
UMLS CUI [5,3]
C2239176
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C1517925
UMLS CUI [6,3]
C0699893
hepatocellular carcinoma with tumor burden outside of the milan criteria
Description

Liver carcinoma | Tumor Burden Criteria Specified

Data type

boolean

Alias
UMLS CUI [1]
C2239176
UMLS CUI [2,1]
C1449699
UMLS CUI [2,2]
C0243161
UMLS CUI [2,3]
C0205369
serum creatinine > 2.5 for > or = six months at the time of enrollment
Description

Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0201976
personal or family history (first degree relative) of deep venous thrombosis or pulmonary embolism
Description

History of Deep vein thrombosis | Family history First Degree Relative 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]
C1517194
UMLS CUI [2,3]
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

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

Data type

boolean

Alias
UMLS CUI [1,1]
C1709854
UMLS CUI [1,2]
C1720451
UMLS CUI [2,1]
C0013018
UMLS CUI [2,2]
C4330254
UMLS CUI [3,1]
C0013018
UMLS CUI [3,2]
C0262506
receipt of liver allograft donated after cardiac death of donor
Description

Recipient Cadaver allograft liver

Data type

boolean

Alias
UMLS CUI [1,1]
C1709854
UMLS CUI [1,2]
C1720130
receipt of any antiviral agents (licensed or investigational) for hepatitis c virus within 90 days prior to enrollment, except for hepatocellular carcinoma patients on treatment with sofosbuvir and ribavirin with detectable hcv rna within 60 days of liver transplantation
Description

Antiviral Agents Hepatitis C virus | Exception Sofosbuvir Liver carcinoma | Exception Ribavirin Liver carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0003451
UMLS CUI [1,2]
C0220847
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C2976303
UMLS CUI [2,3]
C2239176
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0035525
UMLS CUI [3,3]
C2239176
previous receipt of an hcv protease inhibitor (for subjects enrolling in part 1: telaprevir)
Description

Hepatitis C virus Protease Inhibitors

Data type

boolean

Alias
UMLS CUI [1,1]
C0220847
UMLS CUI [1,2]
C0033607
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
seizure disorder requiring anti-convulsant therapy
Description

Epilepsy Requirement Anticonvulsant therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0014544
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0521306
pulmonary arterial hypertension requiring sildenafil or tadalafil infusion (for subjects enrolling in part 1: telaprevir)
Description

Pulmonary arterial hypertension | Sildenafil Required | Tadalafil Required

Data type

boolean

Alias
UMLS CUI [1]
C2973725
UMLS CUI [2,1]
C0529793
UMLS CUI [2,2]
C1514873
UMLS CUI [3,1]
C1176316
UMLS CUI [3,2]
C1514873
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 At risk Patient safety | Condition At risk Patient Rights | Condition Completion of clinical trial Unlikely

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C1444641
UMLS CUI [1,3]
C1113679
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C1444641
UMLS CUI [2,3]
C0030706
UMLS CUI [3,1]
C0348080
UMLS CUI [3,2]
C2732579
UMLS CUI [3,3]
C0750558
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Similar models

Eligibility Hepatitis C Infection NCT01532908

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 1 undergoing liver transplantation from either a deceased donor or living donor.
boolean
C0001779 (UMLS CUI [1])
C0524910 (UMLS CUI [2,1])
C1285573 (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 Legal Guardian
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])
C0023226 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Hepatitis B surface antigen positive
Item
positive for hepatitis b surface antigen
boolean
C0149709 (UMLS CUI [1])
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 | Transplantation of 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])
C0023911 (UMLS CUI [2])
C0022671 (UMLS CUI [3])
Immunoglobulins, Intravenous | Intravenous Immunoglobulins 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 Neoplasm Extrahepatic | Remission Absent | Systemic Chemotherapy | Systemic Radiation Therapy | Exception Chemoembolization Liver carcinoma | Exception Local Therapy Skin carcinoma
Item
extrahepatic malignancy not currently in remission and/or receiving systemic chemotherapy and/or radiation within 90 days prior to enrollment. exceptions include chemoembolization for hepatocellular carcinoma or cutaneous malignancies managed with local treatment
boolean
C0006826 (UMLS CUI [1,1])
C1517058 (UMLS CUI [1,2])
C0687702 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C1883256 (UMLS CUI [3])
C2985381 (UMLS CUI [4])
C1705847 (UMLS CUI [5,1])
C0796679 (UMLS CUI [5,2])
C2239176 (UMLS CUI [5,3])
C1705847 (UMLS CUI [6,1])
C1517925 (UMLS CUI [6,2])
C0699893 (UMLS CUI [6,3])
Liver carcinoma | Tumor Burden Criteria Specified
Item
hepatocellular carcinoma with tumor burden outside of the milan criteria
boolean
C2239176 (UMLS CUI [1])
C1449699 (UMLS CUI [2,1])
C0243161 (UMLS CUI [2,2])
C0205369 (UMLS CUI [2,3])
Creatinine measurement, serum
Item
serum creatinine > 2.5 for > or = six months at the time of enrollment
boolean
C0201976 (UMLS CUI [1])
History of Deep vein thrombosis | Family history First Degree Relative Deep Vein Thrombosis | Personal history of pulmonary embolism | Family history of pulmonary embolism
Item
personal or family history (first degree relative) of deep venous thrombosis or pulmonary embolism
boolean
C0459853 (UMLS CUI [1])
C0241889 (UMLS CUI [2,1])
C1517194 (UMLS CUI [2,2])
C0149871 (UMLS CUI [2,3])
C0585968 (UMLS CUI [3])
C2317597 (UMLS CUI [4])
Recipient Allograft liver | 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
C1709854 (UMLS CUI [1,1])
C1720451 (UMLS CUI [1,2])
C0013018 (UMLS CUI [2,1])
C4330254 (UMLS CUI [2,2])
C0013018 (UMLS CUI [3,1])
C0262506 (UMLS CUI [3,2])
Recipient Cadaver allograft liver
Item
receipt of liver allograft donated after cardiac death of donor
boolean
C1709854 (UMLS CUI [1,1])
C1720130 (UMLS CUI [1,2])
Antiviral Agents Hepatitis C virus | Exception Sofosbuvir Liver carcinoma | Exception Ribavirin Liver carcinoma
Item
receipt of any antiviral agents (licensed or investigational) for hepatitis c virus within 90 days prior to enrollment, except for hepatocellular carcinoma patients on treatment with sofosbuvir and ribavirin with detectable hcv rna within 60 days of liver transplantation
boolean
C0003451 (UMLS CUI [1,1])
C0220847 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C2976303 (UMLS CUI [2,2])
C2239176 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0035525 (UMLS CUI [3,2])
C2239176 (UMLS CUI [3,3])
Hepatitis C virus Protease Inhibitors
Item
previous receipt of an hcv protease inhibitor (for subjects enrolling in part 1: telaprevir)
boolean
C0220847 (UMLS CUI [1,1])
C0033607 (UMLS CUI [1,2])
Investigational New Drugs
Item
receipt of any other investigational study product within 30 days prior to enrollment
boolean
C0013230 (UMLS CUI [1])
Epilepsy Requirement Anticonvulsant therapy
Item
seizure disorder requiring anti-convulsant therapy
boolean
C0014544 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0521306 (UMLS CUI [1,3])
Pulmonary arterial hypertension | Sildenafil Required | Tadalafil Required
Item
pulmonary arterial hypertension requiring sildenafil or tadalafil infusion (for subjects enrolling in part 1: telaprevir)
boolean
C2973725 (UMLS CUI [1])
C0529793 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C1176316 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
Condition At risk Patient safety | Condition At risk Patient Rights | 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])
C1444641 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
C0030706 (UMLS CUI [2,3])
C0348080 (UMLS CUI [3,1])
C2732579 (UMLS CUI [3,2])
C0750558 (UMLS CUI [3,3])
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