ID

36043

Description

Study of Grazoprevir (MK-5172) + Elbasvir (MK-8742) + Ribavirin in Participants With Chronic Hepatitis C Who Failed Prior Direct-Acting Antiviral Therapy (MK-5172-048); ODM derived from: https://clinicaltrials.gov/show/NCT02105454

Link

https://clinicaltrials.gov/show/NCT02105454

Keywords

Versions (1)
  1. 4/11/19 4/11/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 11, 2019

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License

Creative Commons BY 4.0
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Eligibility Hepatitis C Virus NCT02105454

English

Eligibility Hepatitis C Virus NCT02105454

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
documented chronic hcv gt1 infection (with no evidence of non-typable or mixed genotype)
Description

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

Data type

boolean

Alias
UMLS CUI [1,1]
C0524910
UMLS CUI [1,2]
C1533728
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C1533728
UMLS CUI [2,3]
C1272705
UMLS CUI [3,1]
C0332197
UMLS CUI [3,2]
C1148363
UMLS CUI [3,3]
C0205430
absence of cirrhosis, or cirrhosis with these criteria: metavir f4, or fibroscan with result >12.5 kpa, or fibrosure® (fibrotest®) score of >0.75 + aspartate aminotransferase (ast): platelet ratio index (apri) of >2- prior regimen containing an approved daa (boceprevir, telaprevir, simeprevir, or sofosbuvir), pegylated interferon, and/or rbv
Description

Liver Cirrhosis Absent | Liver Cirrhosis Criteria | Metavir score | Fibroscan | FibroTest Score Measurement | AST to platelet ratio index | DIRECT ACTING ANTIVIRALS | boceprevir | telaprevir | simeprevir | sofosbuvir | PEGINTERFERON | Ribavirin

Data type

boolean

Alias
UMLS CUI [1,1]
C0023890
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0023890
UMLS CUI [2,2]
C0243161
UMLS CUI [3]
C3888527
UMLS CUI [4]
C4522043
UMLS CUI [5]
C3642160
UMLS CUI [6]
C4483916
UMLS CUI [7]
C3653501
UMLS CUI [8]
C1738934
UMLS CUI [9]
C1876229
UMLS CUI [10]
C2605855
UMLS CUI [11]
C2976303
UMLS CUI [12]
C0982327
UMLS CUI [13]
C0035525
participants of reproductive potential must agree to remain truly abstinent or use (or have their partner use) 2 acceptable methods of birth control from at least 2 weeks prior to day 1 and continue until at least 6 months after last dose of study drug, or longer if dictated by local regulations
Description

Females & males of reproductive potential Sexual Abstinence | Females & males of reproductive potential Contraceptive methods Quantity | Females & males of reproductive potential Partner Contraceptive methods Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C4034483
UMLS CUI [1,2]
C0036899
UMLS CUI [2,1]
C4034483
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C1265611
UMLS CUI [3,1]
C4034483
UMLS CUI [3,2]
C0682323
UMLS CUI [3,3]
C0700589
UMLS CUI [3,4]
C1265611
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
received any hcv regimen containing a daa with the exception of boceprevir, telaprevir, simeprevir, or sofosbuvir in combination with pegylated interferon and/or rbv
Description

DIRECT ACTING ANTIVIRALS Hepatitis C | Exception Boceprevir | Exception Telaprevir | Exception Simeprevir | Exception Sofosbuvir | Exception PEGINTERFERON | Exception Ribavirin

Data type

boolean

Alias
UMLS CUI [1,1]
C3653501
UMLS CUI [1,2]
C0019196
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1738934
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1876229
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C2605855
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C2976303
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0982327
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C0035525
evidence of decompensated liver disease or cirrhosis
Description

Decompensated liver disease | Liver Cirrhosis

Data type

boolean

Alias
UMLS CUI [1]
C4075847
UMLS CUI [2]
C0023890
co-infected 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]
C4062778
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 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 | Exception Carcinoma in Situ | Exception Evaluation Cancer Other | Exception Evaluation Cancer Other 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 [5,1]
C1705847
UMLS CUI [5,2]
C0007099
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C1261322
UMLS CUI [6,3]
C1707251
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C1261322
UMLS CUI [7,3]
C1707251
UMLS CUI [7,4]
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 | Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
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 or sperm from at least 2 weeks prior to day 1 and continue throughout treatment and follow up, or longer if dictated by local regulations
Description

Pregnancy | Breast Feeding | Ovum Receive Expected | Sperm Receive Expected | Egg Donation Expected | Sperm donation Expected

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0029974
UMLS CUI [3,2]
C1514756
UMLS CUI [3,3]
C1517001
UMLS CUI [4,1]
C0037868
UMLS CUI [4,2]
C1514756
UMLS CUI [4,3]
C1517001
UMLS CUI [5,1]
C4053456
UMLS CUI [5,2]
C1517001
UMLS CUI [6,1]
C0871414
UMLS CUI [6,2]
C1517001
male participant whose female partner (s) is/are pregnant
Description

Gender Partner Pregnancy

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0682323
UMLS CUI [1,3]
C0032961
organ transplants (including hematopoietic stem cell transplants) other than cornea and hair
Description

Organ Transplantation | Hemopoietic stem cell transplant | Exception Cornea transplant | Exception Hair transplant

Data type

boolean

Alias
UMLS CUI [1]
C0029216
UMLS CUI [2]
C0472699
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0080251
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 disorders (e.g., celiac sprue disease)
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C0192398
UMLS CUI [2]
C0149701
UMLS CUI [3]
C0017125
UMLS CUI [4]
C0024523
UMLS CUI [5]
C0007570
hemoglobinopathy, including, but not limited to, thalassemia major
Description

Hemoglobinopathy | Thalassaemia major

Data type

boolean

Alias
UMLS CUI [1]
C0019045
UMLS CUI [2]
C0002875
any medical condition requiring, or likely to require, chronic systemic administration of corticosteroids during the course of the trial
Description

Medical condition Requirement CORTICOSTEROIDS FOR SYSTEMIC USE chronic

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C3653708
UMLS CUI [1,4]
C0205191
evidence or 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 | Absence Cause HCV | Nonalcoholic Steatohepatitis | Hepatitis, Drug-Induced | Hepatitis, Autoimmune

Data type

boolean

Alias
UMLS CUI [1]
C0019189
UMLS CUI [2,1]
C0332197
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 Virus NCT02105454

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Chronic Hepatitis C Genotype determination | Absence Hepatitis C virus genotype determination Unsuccessful | Absence Hepatitis C virus genotype Mixed
Item
documented chronic hcv gt1 infection (with no evidence of non-typable or mixed genotype)
boolean
C0524910 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
C0332197 (UMLS CUI [2,1])
C1533728 (UMLS CUI [2,2])
C1272705 (UMLS CUI [2,3])
C0332197 (UMLS CUI [3,1])
C1148363 (UMLS CUI [3,2])
C0205430 (UMLS CUI [3,3])
Liver Cirrhosis Absent | Liver Cirrhosis Criteria | Metavir score | Fibroscan | FibroTest Score Measurement | AST to platelet ratio index | DIRECT ACTING ANTIVIRALS | boceprevir | telaprevir | simeprevir | sofosbuvir | PEGINTERFERON | Ribavirin
Item
absence of cirrhosis, or cirrhosis with these criteria: metavir f4, or fibroscan with result >12.5 kpa, or fibrosure® (fibrotest®) score of >0.75 + aspartate aminotransferase (ast): platelet ratio index (apri) of >2- prior regimen containing an approved daa (boceprevir, telaprevir, simeprevir, or sofosbuvir), pegylated interferon, and/or rbv
boolean
C0023890 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0023890 (UMLS CUI [2,1])
C0243161 (UMLS CUI [2,2])
C3888527 (UMLS CUI [3])
C4522043 (UMLS CUI [4])
C3642160 (UMLS CUI [5])
C4483916 (UMLS CUI [6])
C3653501 (UMLS CUI [7])
C1738934 (UMLS CUI [8])
C1876229 (UMLS CUI [9])
C2605855 (UMLS CUI [10])
C2976303 (UMLS CUI [11])
C0982327 (UMLS CUI [12])
C0035525 (UMLS CUI [13])
Females & males of reproductive potential Sexual Abstinence | Females & males of reproductive potential Contraceptive methods Quantity | Females & males of reproductive potential Partner Contraceptive methods Quantity
Item
participants of reproductive potential must agree to remain truly abstinent or use (or have their partner use) 2 acceptable methods of birth control from at least 2 weeks prior to day 1 and continue until at least 6 months after last dose of study drug, or longer if dictated by local regulations
boolean
C4034483 (UMLS CUI [1,1])
C0036899 (UMLS CUI [1,2])
C4034483 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C4034483 (UMLS CUI [3,1])
C0682323 (UMLS CUI [3,2])
C0700589 (UMLS CUI [3,3])
C1265611 (UMLS CUI [3,4])
Item Group
C0680251 (UMLS CUI)
DIRECT ACTING ANTIVIRALS Hepatitis C | Exception Boceprevir | Exception Telaprevir | Exception Simeprevir | Exception Sofosbuvir | Exception PEGINTERFERON | Exception Ribavirin
Item
received any hcv regimen containing a daa with the exception of boceprevir, telaprevir, simeprevir, or sofosbuvir in combination with pegylated interferon and/or rbv
boolean
C3653501 (UMLS CUI [1,1])
C0019196 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C1738934 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C1876229 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C2605855 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C2976303 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C0982327 (UMLS CUI [6,2])
C1705847 (UMLS CUI [7,1])
C0035525 (UMLS CUI [7,2])
Decompensated liver disease | Liver Cirrhosis
Item
evidence of decompensated liver disease or cirrhosis
boolean
C4075847 (UMLS CUI [1])
C0023890 (UMLS CUI [2])
HBV coinfection | HIV coinfection
Item
co-infected with hepatitis b virus or human immunodeficiency virus (hiv)
boolean
C2242656 (UMLS CUI [1])
C4062778 (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 Cancer Other | Exception Evaluation Cancer Other 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 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])
C1707251 (UMLS CUI [6,3])
C1705847 (UMLS CUI [7,1])
C1261322 (UMLS CUI [7,2])
C1707251 (UMLS CUI [7,3])
C0750491 (UMLS CUI [7,4])
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 | Investigational New Drugs
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])
C0013230 (UMLS CUI [2])
Substance Use Disorders
Item
clinically-relevant drug or alcohol abuse within 12 months of screening
boolean
C0038586 (UMLS CUI [1])
Pregnancy | Breast Feeding | Ovum Receive Expected | Sperm Receive Expected | Egg Donation Expected | Sperm donation Expected
Item
pregnant, breast-feeding, or expecting to conceive or donate eggs or sperm from at least 2 weeks prior to day 1 and continue throughout treatment and follow up, or longer if dictated by local regulations
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0029974 (UMLS CUI [3,1])
C1514756 (UMLS CUI [3,2])
C1517001 (UMLS CUI [3,3])
C0037868 (UMLS CUI [4,1])
C1514756 (UMLS CUI [4,2])
C1517001 (UMLS CUI [4,3])
C4053456 (UMLS CUI [5,1])
C1517001 (UMLS CUI [5,2])
C0871414 (UMLS CUI [6,1])
C1517001 (UMLS CUI [6,2])
Gender Partner Pregnancy
Item
male participant whose female partner (s) is/are pregnant
boolean
C0079399 (UMLS CUI [1,1])
C0682323 (UMLS CUI [1,2])
C0032961 (UMLS CUI [1,3])
Organ Transplantation | Hemopoietic stem cell transplant | Exception Cornea transplant | Exception Hair transplant
Item
organ transplants (including hematopoietic stem cell transplants) other than cornea and hair
boolean
C0029216 (UMLS CUI [1])
C0472699 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0080251 (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 sprue
Item
history of gastric surgery (e.g., stapling, bypass) or history of malabsorption disorders (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])
Hemoglobinopathy | Thalassaemia major
Item
hemoglobinopathy, including, but not limited to, thalassemia major
boolean
C0019045 (UMLS CUI [1])
C0002875 (UMLS CUI [2])
Medical condition Requirement CORTICOSTEROIDS FOR SYSTEMIC USE chronic
Item
any medical condition requiring, or likely to require, chronic systemic administration of corticosteroids 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])
Hepatitis, Chronic | Absence Cause HCV | Nonalcoholic Steatohepatitis | Hepatitis, Drug-Induced | Hepatitis, Autoimmune
Item
evidence or 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])
C0332197 (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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