ID

35266

Description

Study of Efficacy and Safety of Grazoprevir (MK-5172)/Elbasvir (MK-8742) Combination Regimen for Treatment-Naïve Participants With Chronic Hepatitis C Virus Genotypes 1, 4, and 6 (MK-5172-060); ODM derived from: https://clinicaltrials.gov/show/NCT02105467

Link

https://clinicaltrials.gov/show/NCT02105467

Keywords

Versions (2)
  1. 2/25/19 2/25/19 -
  2. 9/20/21 9/20/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 25, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Chronic Hepatitis C Virus NCT02105467

English

Eligibility Chronic Hepatitis C Virus NCT02105467

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
documented chronic hcv gt1, gt4, or gt6 with no evidence of non-typable or mixed genotype infection (positive for anti-hcv antibody, hcv rna, or any of the listed gts at least 6 months prior to screening must be confirmed by screening lab results)
Description

Chronic Hepatitis C Genotype | Absence Infection Genotype Mixed | Hepatitis C antibody positive | Hepatitis C RNA positive | Hepatitis C virus genotype Positive

Data type

boolean

Alias
UMLS CUI [1,1]
C0524910
UMLS CUI [1,2]
C0017431
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C3714514
UMLS CUI [2,3]
C0017431
UMLS CUI [2,4]
C0205430
UMLS CUI [3]
C0281863
UMLS CUI [4]
C0855842
UMLS CUI [5,1]
C1148363
UMLS CUI [5,2]
C1514241
cirrhosis defined by: liver biopsy showing cirrhosis metavir f4; or fibroscan showing cirrhosis with a result of >12.5 kpa; or fibrosure® (fibrotest®) score of >0.75 and an aspartate aminotransferase (ast): platelet ratio index (apri) of >2
Description

Liver Cirrhosis Metavir score f4 Biopsy of liver | Liver Cirrhosis Fibroscan | Fibrosure | FibroTest Score Measurement | AST to platelet ratio index

Data type

boolean

Alias
UMLS CUI [1,1]
C0023890
UMLS CUI [1,2]
C4481041
UMLS CUI [1,3]
C0193388
UMLS CUI [2,1]
C0023890
UMLS CUI [2,2]
C4522043
UMLS CUI [3]
C1955263
UMLS CUI [4]
C3642160
UMLS CUI [5]
C4483916
absence of cirrhosis defined by: liver biopsy showing absence of cirrhosis, or fibroscan with a result of ≤12.5 kpa, or fibrosure® (fibrotest®) score of <= 0.48 and apri of <=1
Description

Liver Cirrhosis Absent Biopsy of liver | Fibroscan | Fibrosure | FibroTest Score Measurement | AST to platelet ratio index

Data type

boolean

Alias
UMLS CUI [1,1]
C0023890
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0193388
UMLS CUI [2]
C4522043
UMLS CUI [3]
C1955263
UMLS CUI [4]
C3642160
UMLS CUI [5]
C4483916
hcv treatment status of treatment naïve (naïve to all anti-hcv treatment) and can also be ineligible to take pegylated interferon
Description

Therapy naive Anti-hepatitis C (HCV) Agents | Pegylated interferon alfa Ineligible

Data type

boolean

Alias
UMLS CUI [1,1]
C0919936
UMLS CUI [1,2]
C4324240
UMLS CUI [2,1]
C0907160
UMLS CUI [2,2]
C1512714
female participant not of reproductive potential, or female of reproductive potential and agrees to avoid becoming pregnant while receiving study drug and for 14 days after the last dose of study drug (using abstinence or acceptable methods of contraception)
Description

Female infertility | Childbearing Potential Sexual Abstinence | Childbearing Potential Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1]
C0021361
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0036899
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
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. for cirrhotics, participants who are child-pugh class b or c or who have a pugh-turcotte (cpt) score >6
Description

Decompensated liver disease | Ascites | Bleeding esophageal varices | Bleeding gastric varices | Hepatic Encephalopathy | Sign or Symptom Liver disease Advanced | Study Subject Cirrhotic Child-Pugh Classification | Study Subject Cirrhotic Child-Pugh-Turcotte score

Data type

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
UMLS CUI [7,1]
C0681850
UMLS CUI [7,2]
C0439686
UMLS CUI [7,3]
C2347612
UMLS CUI [8,1]
C0681850
UMLS CUI [8,2]
C0439686
UMLS CUI [8,3]
C3854424
co-infection with hepatitis b virus or human immunodeficiency virus (hiv)
Description

HBV coinfection | HIV Coinfection

Data type

boolean

Alias
UMLS CUI [1]
C2242656
UMLS CUI [2]
C4505456
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
Description

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

Data type

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 [4,3]
C1522326
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0007099
UMLS CUI [5,3]
C1522326
UMLS CUI [6,1]
C1261322
UMLS CUI [6,2]
C1707251
UMLS CUI [7,1]
C1261322
UMLS CUI [7,2]
C0006826
UMLS CUI [7,3]
C0750491
evidence of hepatocellular carcinoma (hcc) or under evaluation for hcc
Description

Liver carcinoma | Evaluation Liver carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C2239176
UMLS CUI [2,1]
C1261322
UMLS CUI [2,2]
C2239176
currently participating or has participated in a study with an investigational compound within 30 days of signing informed consent and is not willing to refrain from participating in another such study during the course of this study
Description

Study Subject Participation Status | Compound Investigational

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C1706082
UMLS CUI [2,2]
C1517586
clinically-relevant drug or alcohol abuse within 12 months of screening
Description

Substance Use Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0038586
pregnant, breast-feeding, or expecting to conceive or donate eggs from day 1 throughout treatment and 14 days after the last dose of study medication or longer if dictated by local regulations
Description

Pregnancy | Breast Feeding | Egg Donation Expected

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C4053456
UMLS CUI [3,2]
C1517001
organ transplant (including hematopoietic stem cell transplants) other than cornea and hair
Description

Organ Transplantation | Hemopoietic stem cell transplant | Exception Keratoplasty | Exception Hair transplant procedure

Data type

boolean

Alias
UMLS CUI [1]
C0029216
UMLS CUI [2]
C0472699
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0010042
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0191626
poor venous access
Description

Poor venous access

Data type

boolean

Alias
UMLS CUI [1]
C0577866
history of gastric surgery (e.g., stapling, bypass) or history of malabsorption disorder (e.g., celiac sprue disease)
Description

Operation on stomach | Stomach Stapling | Gastric Bypass | Malabsorption Syndrome | Celiac Disease

Data type

boolean

Alias
UMLS CUI [1]
C0192398
UMLS CUI [2]
C0149701
UMLS CUI [3]
C0017125
UMLS CUI [4]
C0024523
UMLS CUI [5]
C0007570
any medical condition requiring, or likely to require, chronic systemic administration of corticosteroids, tnf antagonists, or other immunosuppressant drugs during the course of the trial
Description

Medical condition Requirement CORTICOSTEROIDS FOR SYSTEMIC USE chronic | Medical condition Requirement Tumor necrosis factor alpha inhibitors | Medical condition Requirement Immunosuppressive Agents

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C3653708
UMLS CUI [1,4]
C0205191
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C3653350
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C1514873
UMLS CUI [3,3]
C0021081
evidence of history of chronic hepatitis not caused by hcv, including but not limited to nonalcoholic steatohepatitis (nash), drug-induced hepatitis, and autoimmune hepatitis
Description

Hepatitis, Chronic | Independent of Hepatitis C virus | Nonalcoholic Steatohepatitis | Hepatitis, Drug-Induced | Hepatitis, Autoimmune

Data type

boolean

Alias
UMLS CUI [1]
C0019189
UMLS CUI [2,1]
C0332291
UMLS CUI [2,2]
C0220847
UMLS CUI [3]
C3241937
UMLS CUI [4]
C1262760
UMLS CUI [5]
C0241910
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Similar models

Eligibility Chronic Hepatitis C Virus NCT02105467

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Chronic Hepatitis C Genotype | Absence Infection Genotype Mixed | Hepatitis C antibody positive | Hepatitis C RNA positive | Hepatitis C virus genotype Positive
Item
documented chronic hcv gt1, gt4, or gt6 with no evidence of non-typable or mixed genotype infection (positive for anti-hcv antibody, hcv rna, or any of the listed gts at least 6 months prior to screening must be confirmed by screening lab results)
boolean
C0524910 (UMLS CUI [1,1])
C0017431 (UMLS CUI [1,2])
C0332197 (UMLS CUI [2,1])
C3714514 (UMLS CUI [2,2])
C0017431 (UMLS CUI [2,3])
C0205430 (UMLS CUI [2,4])
C0281863 (UMLS CUI [3])
C0855842 (UMLS CUI [4])
C1148363 (UMLS CUI [5,1])
C1514241 (UMLS CUI [5,2])
Liver Cirrhosis Metavir score f4 Biopsy of liver | Liver Cirrhosis Fibroscan | Fibrosure | FibroTest Score Measurement | AST to platelet ratio index
Item
cirrhosis defined by: liver biopsy showing cirrhosis metavir f4; or fibroscan showing cirrhosis with a result of >12.5 kpa; or fibrosure® (fibrotest®) score of >0.75 and an aspartate aminotransferase (ast): platelet ratio index (apri) of >2
boolean
C0023890 (UMLS CUI [1,1])
C4481041 (UMLS CUI [1,2])
C0193388 (UMLS CUI [1,3])
C0023890 (UMLS CUI [2,1])
C4522043 (UMLS CUI [2,2])
C1955263 (UMLS CUI [3])
C3642160 (UMLS CUI [4])
C4483916 (UMLS CUI [5])
Liver Cirrhosis Absent Biopsy of liver | Fibroscan | Fibrosure | FibroTest Score Measurement | AST to platelet ratio index
Item
absence of cirrhosis defined by: liver biopsy showing absence of cirrhosis, or fibroscan with a result of ≤12.5 kpa, or fibrosure® (fibrotest®) score of <= 0.48 and apri of <=1
boolean
C0023890 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0193388 (UMLS CUI [1,3])
C4522043 (UMLS CUI [2])
C1955263 (UMLS CUI [3])
C3642160 (UMLS CUI [4])
C4483916 (UMLS CUI [5])
Therapy naive Anti-hepatitis C (HCV) Agents | Pegylated interferon alfa Ineligible
Item
hcv treatment status of treatment naïve (naïve to all anti-hcv treatment) and can also be ineligible to take pegylated interferon
boolean
C0919936 (UMLS CUI [1,1])
C4324240 (UMLS CUI [1,2])
C0907160 (UMLS CUI [2,1])
C1512714 (UMLS CUI [2,2])
Female infertility | Childbearing Potential Sexual Abstinence | Childbearing Potential Contraceptive methods
Item
female participant not of reproductive potential, or female of reproductive potential and agrees to avoid becoming pregnant while receiving study drug and for 14 days after the last dose of study drug (using abstinence or acceptable methods of contraception)
boolean
C0021361 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0036899 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Decompensated liver disease | Ascites | Bleeding esophageal varices | Bleeding gastric varices | Hepatic Encephalopathy | Sign or Symptom Liver disease Advanced | Study Subject Cirrhotic Child-Pugh Classification | Study Subject Cirrhotic Child-Pugh-Turcotte score
Item
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. for cirrhotics, participants who are child-pugh class b or c or who have a pugh-turcotte (cpt) score >6
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])
C0681850 (UMLS CUI [7,1])
C0439686 (UMLS CUI [7,2])
C2347612 (UMLS CUI [7,3])
C0681850 (UMLS CUI [8,1])
C0439686 (UMLS CUI [8,2])
C3854424 (UMLS CUI [8,3])
HBV coinfection | HIV Coinfection
Item
co-infection with hepatitis b virus or human immunodeficiency virus (hiv)
boolean
C2242656 (UMLS CUI [1])
C4505456 (UMLS CUI [2])
Malignant Neoplasms | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of uterine cervix Treated | Exception Carcinoma in Situ Treated | Evaluation Cancer Other | Evaluation Malignant Neoplasms Suspected
Item
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])
C1522326 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0007099 (UMLS CUI [5,2])
C1522326 (UMLS CUI [5,3])
C1261322 (UMLS CUI [6,1])
C1707251 (UMLS CUI [6,2])
C1261322 (UMLS CUI [7,1])
C0006826 (UMLS CUI [7,2])
C0750491 (UMLS CUI [7,3])
Liver carcinoma | Evaluation Liver carcinoma
Item
evidence of hepatocellular carcinoma (hcc) or under evaluation for hcc
boolean
C2239176 (UMLS CUI [1])
C1261322 (UMLS CUI [2,1])
C2239176 (UMLS CUI [2,2])
Study Subject Participation Status | Compound Investigational
Item
currently participating or has participated in a study with an investigational compound within 30 days of signing informed consent and is not willing to refrain from participating in another such study during the course of this study
boolean
C2348568 (UMLS CUI [1])
C1706082 (UMLS CUI [2,1])
C1517586 (UMLS CUI [2,2])
Substance Use Disorders
Item
clinically-relevant drug or alcohol abuse within 12 months of screening
boolean
C0038586 (UMLS CUI [1])
Pregnancy | Breast Feeding | Egg Donation Expected
Item
pregnant, breast-feeding, or expecting to conceive or donate eggs from day 1 throughout treatment and 14 days after the last dose of study medication or longer if dictated by local regulations
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C4053456 (UMLS CUI [3,1])
C1517001 (UMLS CUI [3,2])
Organ Transplantation | Hemopoietic stem cell transplant | Exception Keratoplasty | Exception Hair transplant procedure
Item
organ transplant (including hematopoietic stem cell transplants) other than cornea and hair
boolean
C0029216 (UMLS CUI [1])
C0472699 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0010042 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0191626 (UMLS CUI [4,2])
Poor venous access
Item
poor venous access
boolean
C0577866 (UMLS CUI [1])
Operation on stomach | Stomach Stapling | Gastric Bypass | Malabsorption Syndrome | Celiac Disease
Item
history of gastric surgery (e.g., stapling, bypass) or history of malabsorption disorder (e.g., celiac sprue disease)
boolean
C0192398 (UMLS CUI [1])
C0149701 (UMLS CUI [2])
C0017125 (UMLS CUI [3])
C0024523 (UMLS CUI [4])
C0007570 (UMLS CUI [5])
Medical condition Requirement CORTICOSTEROIDS FOR SYSTEMIC USE chronic | Medical condition Requirement Tumor necrosis factor alpha inhibitors | Medical condition Requirement Immunosuppressive Agents
Item
any medical condition requiring, or likely to require, chronic systemic administration of corticosteroids, tnf antagonists, or other immunosuppressant drugs during the course of the trial
boolean
C3843040 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C3653708 (UMLS CUI [1,3])
C0205191 (UMLS CUI [1,4])
C3843040 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C3653350 (UMLS CUI [2,3])
C3843040 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C0021081 (UMLS CUI [3,3])
Hepatitis, Chronic | Independent of Hepatitis C virus | Nonalcoholic Steatohepatitis | Hepatitis, Drug-Induced | Hepatitis, Autoimmune
Item
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])
C0332291 (UMLS CUI [2,1])
C0220847 (UMLS CUI [2,2])
C3241937 (UMLS CUI [3])
C1262760 (UMLS CUI [4])
C0241910 (UMLS CUI [5])
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