ID

36031

Descrizione

Grazoprevir (MK-5172)/Elbasvir (MK-8742) Versus Boceprevir/Pegylated Interferon/Ribavarin for Chronic Hepatitis C Infection (MK-5172-066); ODM derived from: https://clinicaltrials.gov/show/NCT02204475

collegamento

https://clinicaltrials.gov/show/NCT02204475

Keywords

versioni (1)
  1. 09/04/19 09/04/19 -
Titolare del copyright

See clinicaltrials.gov

Caricato su

9 aprile 2019

DOI

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Licenza

Creative Commons BY 4.0
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Eligibility Hepatitis C NCT02204475

Inglese

Eligibility Hepatitis C NCT02204475

1 moduli  
Inclusion Criteria
Descrizione

Inclusion Criteria

Alias
UMLS CUI
C1512693
has hcv rna ≥ 10,000 iu/ml at the time of screening
Descrizione

Hepatitis C virus RNA assay

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1272251
has documented chronic hcv gt 1 with no evidence of non-typeable or mixed gt infection
Descrizione

Chronic Hepatitis C Genotype determination | Absence Hepatitis C Genotype determination Unsuccessful | Absence Hepatitis C Genotype Mixed

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0524910
UMLS CUI [1,2]
C1285573
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C0019196
UMLS CUI [2,3]
C1285573
UMLS CUI [2,4]
C1272705
UMLS CUI [3,1]
C0332197
UMLS CUI [3,2]
C0019196
UMLS CUI [3,3]
C0017431
UMLS CUI [3,4]
C0205430
is cirrhotic or non-cirrhotic
Descrizione

Cirrhotic | Non-cirrhotic

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0439686
UMLS CUI [2]
C0439687
has hcv treatment status that is treatment naïve, pr null responder; pr partial responder; or prior pr relapser
Descrizione

Therapy naive | Therapy non-responder | Therapy partial responder | Recurrent disease

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0919936
UMLS CUI [2]
C0919875
UMLS CUI [3]
C4285679
UMLS CUI [4]
C0277556
if human immunodeficiency virus (hiv) co-infected (hiv-1) must be naïve to treatment with any antiretroviral therapy (art) and have no plans to initiate art treatment while participating in this trial, or be on hiv art for at least 8 weeks prior to trial entry (no changes in hiv regimen are allowed within 4 weeks of registration); must also have at least one viable antiretroviral therapy alternative beyond their current regimens in the event of hiv virologic failure and the development of antiretroviral drug resistance
Descrizione

Coinfection HIV-1 | Therapy naive Antiretroviral therapy | Alternative Quantity Antiretroviral therapy

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0275524
UMLS CUI [1,2]
C0019704
UMLS CUI [2,1]
C0919936
UMLS CUI [2,2]
C1963724
UMLS CUI [3,1]
C1523987
UMLS CUI [3,2]
C1265611
UMLS CUI [3,3]
C1963724
use an acceptable method of contraception or not be of childbearing potential
Descrizione

Use of Contraceptive methods | Childbearing Potential Absent

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1524063
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0332197
Exclusion Criteria
Descrizione

Exclusion Criteria

Alias
UMLS CUI
C0680251
has evidence of decompensated liver disease manifested by the presence of or history of ascites, esophageal or gastric variceal bleeding, hepatic encephalopathy or other signs or symptoms of advanced liver disease
Descrizione

Decompensated liver disease | Ascites | Bleeding esophageal varices | Bleeding gastric varices | Hepatic Encephalopathy | Sign or Symptom Liver diseases Advanced

Tipo di dati

boolean

Alias
UMLS CUI [1]
C4075847
UMLS CUI [2]
C0003962
UMLS CUI [3]
C0155789
UMLS CUI [4]
C0267209
UMLS CUI [5]
C0019151
UMLS CUI [6,1]
C3540840
UMLS CUI [6,2]
C0023895
UMLS CUI [6,3]
C0205179
is co-infected with hepatitis b virus (e.g., hepatitis b surface antigen [hbsag] positive)
Descrizione

HBV coinfection | Hepatitis B surface antigen positive

Tipo di dati

boolean

Alias
UMLS CUI [1]
C2242656
UMLS CUI [2]
C0149709
has a history of malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer or carcinoma in situ; or is under evaluation for other active or suspected malignancy
Descrizione

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

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0553723
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0851140
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0007099
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C1261322
UMLS CUI [6,3]
C0006826
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C1261322
UMLS CUI [7,3]
C0006826
UMLS CUI [7,4]
C0750491
has cirrhosis and liver imaging within 6 months of day 1 showing evidence of hepatocellular carcinoma (hcc) or is under evaluation for hcc
Descrizione

Liver Cirrhosis | Imaging of liver | Liver carcinoma | Evaluation Liver carcinoma

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0023890
UMLS CUI [2]
C2711860
UMLS CUI [3]
C2239176
UMLS CUI [4,1]
C1261322
UMLS CUI [4,2]
C2239176
has pre-existing psychiatric condition(s)
Descrizione

Mental disorders Pre-existing

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C2347662
has clinically-relevant drug or alcohol abuse within 12 months of screening
Descrizione

Substance Use Disorders

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0038586
is a female and is pregnant or breast-feeding, or expecting to become pregnant or donate eggs from day 1 throughout treatment and until at least 6 months after the last dose of study medication, or longer if dictated by local regulations; or is a male subject and is planning to impregnate or provide sperm donation
Descrizione

Pregnancy | Breast Feeding | Pregnancy Expected | Egg Donation Expected | Gender Reproduction Planned | Gender Sperm donation Planned

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0032961
UMLS CUI [3,2]
C1517001
UMLS CUI [4,1]
C4053456
UMLS CUI [4,2]
C1517001
UMLS CUI [5,1]
C0079399
UMLS CUI [5,2]
C0035150
UMLS CUI [5,3]
C1301732
UMLS CUI [6,1]
C0079399
UMLS CUI [6,2]
C0871414
UMLS CUI [6,3]
C1301732
has any preexisting condition or prestudy laboratory abnormality, electrocardiogram (ecg) abnormality or history of any illness, which, in the opinion of the investigator, might confound the results of the trial or pose additional risk in administering the study drug(s) to the subject
Descrizione

Pre-existing condition Interferes with Research results | Laboratory test result abnormal Interferes with Research results | Electrocardiogram abnormal Interferes with Research results | Illness Interferes with Research results | Pre-existing condition Investigational New Drugs At risk | Laboratory test result abnormal Investigational New Drugs At risk | Electrocardiogram abnormal Investigational New Drugs At risk | Illness Investigational New Drugs At risk

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0521987
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0683954
UMLS CUI [2,1]
C0438215
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0683954
UMLS CUI [3,1]
C0522055
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0683954
UMLS CUI [4,1]
C0221423
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C0683954
UMLS CUI [5,1]
C0521987
UMLS CUI [5,2]
C0013230
UMLS CUI [5,3]
C1444641
UMLS CUI [6,1]
C0438215
UMLS CUI [6,2]
C0013230
UMLS CUI [6,3]
C1444641
UMLS CUI [7,1]
C0522055
UMLS CUI [7,2]
C0013230
UMLS CUI [7,3]
C1444641
UMLS CUI [8,1]
C0221423
UMLS CUI [8,2]
C0013230
UMLS CUI [8,3]
C1444641
has a life-threatening severe ae (sae) during the screening period
Descrizione

Life Threatening Adverse Event Severe

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1517874
UMLS CUI [1,2]
C0205082
has evidence of history of chronic hepatitis not caused by hcv, including but not limited to nonalcoholic steatohepatitis (nash), drug-induced hepatitis, and autoimmune hepatitis
Descrizione

Hepatitis, Chronic | Exception Etiology HCV | Nonalcoholic Steatohepatitis | Hepatitis, Drug-Induced | Hepatitis, Autoimmune

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0019189
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0015127
UMLS CUI [2,3]
C0220847
UMLS CUI [3]
C3241937
UMLS CUI [4]
C1262760
UMLS CUI [5]
C0241910
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Similar models

Eligibility Hepatitis C NCT02204475

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
C1512693 (UMLS CUI)
Hepatitis C virus RNA assay
Item
has hcv rna ≥ 10,000 iu/ml at the time of screening
boolean
C1272251 (UMLS CUI [1])
Chronic Hepatitis C Genotype determination | Absence Hepatitis C Genotype determination Unsuccessful | Absence Hepatitis C Genotype Mixed
Item
has documented chronic hcv gt 1 with no evidence of non-typeable or mixed gt infection
boolean
C0524910 (UMLS CUI [1,1])
C1285573 (UMLS CUI [1,2])
C0332197 (UMLS CUI [2,1])
C0019196 (UMLS CUI [2,2])
C1285573 (UMLS CUI [2,3])
C1272705 (UMLS CUI [2,4])
C0332197 (UMLS CUI [3,1])
C0019196 (UMLS CUI [3,2])
C0017431 (UMLS CUI [3,3])
C0205430 (UMLS CUI [3,4])
Cirrhotic | Non-cirrhotic
Item
is cirrhotic or non-cirrhotic
boolean
C0439686 (UMLS CUI [1])
C0439687 (UMLS CUI [2])
Therapy naive | Therapy non-responder | Therapy partial responder | Recurrent disease
Item
has hcv treatment status that is treatment naïve, pr null responder; pr partial responder; or prior pr relapser
boolean
C0919936 (UMLS CUI [1])
C0919875 (UMLS CUI [2])
C4285679 (UMLS CUI [3])
C0277556 (UMLS CUI [4])
Coinfection HIV-1 | Therapy naive Antiretroviral therapy | Alternative Quantity Antiretroviral therapy
Item
if human immunodeficiency virus (hiv) co-infected (hiv-1) must be naïve to treatment with any antiretroviral therapy (art) and have no plans to initiate art treatment while participating in this trial, or be on hiv art for at least 8 weeks prior to trial entry (no changes in hiv regimen are allowed within 4 weeks of registration); must also have at least one viable antiretroviral therapy alternative beyond their current regimens in the event of hiv virologic failure and the development of antiretroviral drug resistance
boolean
C0275524 (UMLS CUI [1,1])
C0019704 (UMLS CUI [1,2])
C0919936 (UMLS CUI [2,1])
C1963724 (UMLS CUI [2,2])
C1523987 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C1963724 (UMLS CUI [3,3])
Use of Contraceptive methods | Childbearing Potential Absent
Item
use an acceptable method of contraception or not be of childbearing potential
boolean
C1524063 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Decompensated liver disease | Ascites | Bleeding esophageal varices | Bleeding gastric varices | Hepatic Encephalopathy | Sign or Symptom Liver diseases Advanced
Item
has evidence of decompensated liver disease manifested by the presence of or history of ascites, esophageal or gastric variceal bleeding, hepatic encephalopathy or other signs or symptoms of advanced liver disease
boolean
C4075847 (UMLS CUI [1])
C0003962 (UMLS CUI [2])
C0155789 (UMLS CUI [3])
C0267209 (UMLS CUI [4])
C0019151 (UMLS CUI [5])
C3540840 (UMLS CUI [6,1])
C0023895 (UMLS CUI [6,2])
C0205179 (UMLS CUI [6,3])
HBV coinfection | Hepatitis B surface antigen positive
Item
is co-infected with hepatitis b virus (e.g., hepatitis b surface antigen [hbsag] positive)
boolean
C2242656 (UMLS CUI [1])
C0149709 (UMLS CUI [2])
Malignant Neoplasms | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of uterine cervix | Exception Carcinoma in Situ | Exception Evaluation Malignant Neoplasms | Exception Evaluation Malignant Neoplasms Suspected
Item
has a history of malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer or carcinoma in situ; or is under evaluation for other active or suspected malignancy
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0007099 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C1261322 (UMLS CUI [6,2])
C0006826 (UMLS CUI [6,3])
C1705847 (UMLS CUI [7,1])
C1261322 (UMLS CUI [7,2])
C0006826 (UMLS CUI [7,3])
C0750491 (UMLS CUI [7,4])
Liver Cirrhosis | Imaging of liver | Liver carcinoma | Evaluation Liver carcinoma
Item
has cirrhosis and liver imaging within 6 months of day 1 showing evidence of hepatocellular carcinoma (hcc) or is under evaluation for hcc
boolean
C0023890 (UMLS CUI [1])
C2711860 (UMLS CUI [2])
C2239176 (UMLS CUI [3])
C1261322 (UMLS CUI [4,1])
C2239176 (UMLS CUI [4,2])
Mental disorders Pre-existing
Item
has pre-existing psychiatric condition(s)
boolean
C0004936 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
Substance Use Disorders
Item
has clinically-relevant drug or alcohol abuse within 12 months of screening
boolean
C0038586 (UMLS CUI [1])
Pregnancy | Breast Feeding | Pregnancy Expected | Egg Donation Expected | Gender Reproduction Planned | Gender Sperm donation Planned
Item
is a female and is pregnant or breast-feeding, or expecting to become pregnant or donate eggs from day 1 throughout treatment and until at least 6 months after the last dose of study medication, or longer if dictated by local regulations; or is a male subject and is planning to impregnate or provide sperm donation
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032961 (UMLS CUI [3,1])
C1517001 (UMLS CUI [3,2])
C4053456 (UMLS CUI [4,1])
C1517001 (UMLS CUI [4,2])
C0079399 (UMLS CUI [5,1])
C0035150 (UMLS CUI [5,2])
C1301732 (UMLS CUI [5,3])
C0079399 (UMLS CUI [6,1])
C0871414 (UMLS CUI [6,2])
C1301732 (UMLS CUI [6,3])
Pre-existing condition Interferes with Research results | Laboratory test result abnormal Interferes with Research results | Electrocardiogram abnormal Interferes with Research results | Illness Interferes with Research results | Pre-existing condition Investigational New Drugs At risk | Laboratory test result abnormal Investigational New Drugs At risk | Electrocardiogram abnormal Investigational New Drugs At risk | Illness Investigational New Drugs At risk
Item
has any preexisting condition or prestudy laboratory abnormality, electrocardiogram (ecg) abnormality or history of any illness, which, in the opinion of the investigator, might confound the results of the trial or pose additional risk in administering the study drug(s) to the subject
boolean
C0521987 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0683954 (UMLS CUI [1,3])
C0438215 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0683954 (UMLS CUI [2,3])
C0522055 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0683954 (UMLS CUI [3,3])
C0221423 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0683954 (UMLS CUI [4,3])
C0521987 (UMLS CUI [5,1])
C0013230 (UMLS CUI [5,2])
C1444641 (UMLS CUI [5,3])
C0438215 (UMLS CUI [6,1])
C0013230 (UMLS CUI [6,2])
C1444641 (UMLS CUI [6,3])
C0522055 (UMLS CUI [7,1])
C0013230 (UMLS CUI [7,2])
C1444641 (UMLS CUI [7,3])
C0221423 (UMLS CUI [8,1])
C0013230 (UMLS CUI [8,2])
C1444641 (UMLS CUI [8,3])
Life Threatening Adverse Event Severe
Item
has a life-threatening severe ae (sae) during the screening period
boolean
C1517874 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Hepatitis, Chronic | Exception Etiology HCV | Nonalcoholic Steatohepatitis | Hepatitis, Drug-Induced | Hepatitis, Autoimmune
Item
has evidence of history of chronic hepatitis not caused by hcv, including but not limited to nonalcoholic steatohepatitis (nash), drug-induced hepatitis, and autoimmune hepatitis
boolean
C0019189 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0015127 (UMLS CUI [2,2])
C0220847 (UMLS CUI [2,3])
C3241937 (UMLS CUI [3])
C1262760 (UMLS CUI [4])
C0241910 (UMLS CUI [5])
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