ID

36021

Beskrivning

Study of Grazoprevir (MK-5172) and Elbasvir (MK-8742) in Japanese Participants With Chronic Hepatitis C (MK-5172-058); ODM derived from: https://clinicaltrials.gov/show/NCT02203149

Länk

https://clinicaltrials.gov/show/NCT02203149

Nyckelord

Versioner (1)
  1. 2019-04-09 2019-04-09 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

9 april 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Hepatitis C NCT02203149

Engelsk

Eligibility Hepatitis C NCT02203149

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
has documented chronic japanese hcv genotype (gt) 1 with no evidence of non-typeable or mixed gt infection
Beskrivning

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

Datatyp

boolean

Alias
UMLS CUI [1]
C1556094
UMLS CUI [2,1]
C0524910
UMLS CUI [2,2]
C1285573
UMLS CUI [3,1]
C0332197
UMLS CUI [3,2]
C0019196
UMLS CUI [3,3]
C1285573
UMLS CUI [3,4]
C1272705
UMLS CUI [4,1]
C0332197
UMLS CUI [4,2]
C0019196
UMLS CUI [4,3]
C0017431
UMLS CUI [4,4]
C0205430
is treatment-naïve, or intolerant or non-responder to prior anti-hcv ifn-based treatment without direct acting antiviral (daa) therapy, prior ifn-based treatment with daa therapy, or prior daa therapy
Beskrivning

Therapy naive | Intolerance Interferon Anti-HCV Agents | Therapy non-responder Interferon Anti-HCV Agents | Intolerance Interferon DIRECT ACTING ANTIVIRALS | Therapy non-responder Interferon DIRECT ACTING ANTIVIRALS | Intolerance DIRECT ACTING ANTIVIRALS | Therapy non-responder DIRECT ACTING ANTIVIRALS

Datatyp

boolean

Alias
UMLS CUI [1]
C0919936
UMLS CUI [2,1]
C0231199
UMLS CUI [2,2]
C3652465
UMLS CUI [2,3]
C4324239
UMLS CUI [3,1]
C0919875
UMLS CUI [3,2]
C3652465
UMLS CUI [3,3]
C4324239
UMLS CUI [4,1]
C0231199
UMLS CUI [4,2]
C3652465
UMLS CUI [4,3]
C3653501
UMLS CUI [5,1]
C0919875
UMLS CUI [5,2]
C3652465
UMLS CUI [5,3]
C3653501
UMLS CUI [6,1]
C0231199
UMLS CUI [6,2]
C3653501
UMLS CUI [7,1]
C0919875
UMLS CUI [7,2]
C3653501
agrees to the use of contraception if a female of reproductive potential
Beskrivning

Childbearing Potential Contraceptive methods

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
Exclusion Criteria
Beskrivning

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
Beskrivning

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

Datatyp

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 coinfected with hepatitis b virus or human immunodeficiency virus (hiv)
Beskrivning

HBV coinfection | HIV coinfection

Datatyp

boolean

Alias
UMLS CUI [1]
C2242656
UMLS CUI [2]
C4062778
has a history of malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or carcinoma in situ
Beskrivning

Malignant Neoplasms | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in Situ

Datatyp

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]
C0007099
has cirrhosis and liver imaging within 6 months of day 1 showing evidence of hepatocellular carcinoma (hcc) or is under evaluation for hcc (part 2 only)
Beskrivning

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

Datatyp

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 clinically-relevant drug or alcohol abuse within 12 months of screening
Beskrivning

Substance Use Disorders

Datatyp

boolean

Alias
UMLS CUI [1]
C0038586
is a female and is pregnant or breast-feeding, or expecting to conceive or donate eggs from day 1 and continue throughout treatment and follow-up (or longer if dictated by local regulations)
Beskrivning

Pregnancy | Breast Feeding | Pregnancy Expected | Egg Donation Expected

Datatyp

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
has any of the following conditions:
Beskrivning

Condition Any

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C1552551
organ transplants (including hematopoietic stem cell transplants) other than cornea and hair
Beskrivning

Organ Transplantation | Hemopoietic stem cell transplant | Exception Transplanted cornea | Exception Hair transplant

Datatyp

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
Beskrivning

Poor venous access

Datatyp

boolean

Alias
UMLS CUI [1]
C0577866
history of gastric surgery (e.g., stapling, bypass) or subject with a history of malabsorption disorders (e.g., celiac sprue disease)
Beskrivning

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

Datatyp

boolean

Alias
UMLS CUI [1]
C0192398
UMLS CUI [2]
C0149701
UMLS CUI [3]
C0017125
UMLS CUI [4]
C0024523
UMLS CUI [5]
C0007570
history of a medical/surgical condition that resulted in hospitalization within the 3 months prior to enrollment, other than for minor elective procedures
Beskrivning

Medical condition Resulting in Hospitalization | Exception Minor Surgical Procedures elective

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0332294
UMLS CUI [1,3]
C0019993
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0038904
UMLS CUI [2,3]
C0439608
medical/surgical conditions that may result in a need for hospitalization during the period of the study
Beskrivning

Medical condition Requirement Hospitalization

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0019993
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
Beskrivning

Medical condition Requirement CORTICOSTEROIDS FOR SYSTEMIC USE chronic | Medical condition Requirement TNF Blocker | Medical condition Requirement Immunosuppressive Agents

Datatyp

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]
C2343929
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C1514873
UMLS CUI [3,3]
C0021081
has chronic hepatitis not caused by hcv, including but not limited to nonalcoholic steatohepatitis (nash), drug-induced hepatitis, and autoimmune hepatitis
Beskrivning

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

Datatyp

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 NCT02203149

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Japanese | Chronic Hepatitis C Genotype determination | Absence Hepatitis C Genotype determination Unsuccessful | Absence Hepatitis C Genotype Mixed
Item
has documented chronic japanese hcv genotype (gt) 1 with no evidence of non-typeable or mixed gt infection
boolean
C1556094 (UMLS CUI [1])
C0524910 (UMLS CUI [2,1])
C1285573 (UMLS CUI [2,2])
C0332197 (UMLS CUI [3,1])
C0019196 (UMLS CUI [3,2])
C1285573 (UMLS CUI [3,3])
C1272705 (UMLS CUI [3,4])
C0332197 (UMLS CUI [4,1])
C0019196 (UMLS CUI [4,2])
C0017431 (UMLS CUI [4,3])
C0205430 (UMLS CUI [4,4])
Therapy naive | Intolerance Interferon Anti-HCV Agents | Therapy non-responder Interferon Anti-HCV Agents | Intolerance Interferon DIRECT ACTING ANTIVIRALS | Therapy non-responder Interferon DIRECT ACTING ANTIVIRALS | Intolerance DIRECT ACTING ANTIVIRALS | Therapy non-responder DIRECT ACTING ANTIVIRALS
Item
is treatment-naïve, or intolerant or non-responder to prior anti-hcv ifn-based treatment without direct acting antiviral (daa) therapy, prior ifn-based treatment with daa therapy, or prior daa therapy
boolean
C0919936 (UMLS CUI [1])
C0231199 (UMLS CUI [2,1])
C3652465 (UMLS CUI [2,2])
C4324239 (UMLS CUI [2,3])
C0919875 (UMLS CUI [3,1])
C3652465 (UMLS CUI [3,2])
C4324239 (UMLS CUI [3,3])
C0231199 (UMLS CUI [4,1])
C3652465 (UMLS CUI [4,2])
C3653501 (UMLS CUI [4,3])
C0919875 (UMLS CUI [5,1])
C3652465 (UMLS CUI [5,2])
C3653501 (UMLS CUI [5,3])
C0231199 (UMLS CUI [6,1])
C3653501 (UMLS CUI [6,2])
C0919875 (UMLS CUI [7,1])
C3653501 (UMLS CUI [7,2])
Childbearing Potential Contraceptive methods
Item
agrees to the use of contraception if a female of reproductive potential
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
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 | HIV coinfection
Item
is coinfected 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
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 carcinoma in situ
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])
C0007099 (UMLS CUI [4,2])
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 (part 2 only)
boolean
C0023890 (UMLS CUI [1])
C2711860 (UMLS CUI [2])
C2239176 (UMLS CUI [3])
C1261322 (UMLS CUI [4,1])
C2239176 (UMLS CUI [4,2])
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
Item
is a female and is pregnant or breast-feeding, or expecting to conceive or donate eggs from 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])
C0032961 (UMLS CUI [3,1])
C1517001 (UMLS CUI [3,2])
C4053456 (UMLS CUI [4,1])
C1517001 (UMLS CUI [4,2])
Condition Any
Item
has any of the following conditions:
boolean
C0348080 (UMLS CUI [1,1])
C1552551 (UMLS CUI [1,2])
Organ Transplantation | Hemopoietic stem cell transplant | Exception Transplanted cornea | 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 Disease
Item
history of gastric surgery (e.g., stapling, bypass) or subject with a 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])
Medical condition Resulting in Hospitalization | Exception Minor Surgical Procedures elective
Item
history of a medical/surgical condition that resulted in hospitalization within the 3 months prior to enrollment, other than for minor elective procedures
boolean
C3843040 (UMLS CUI [1,1])
C0332294 (UMLS CUI [1,2])
C0019993 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0038904 (UMLS CUI [2,2])
C0439608 (UMLS CUI [2,3])
Medical condition Requirement Hospitalization
Item
medical/surgical conditions that may result in a need for hospitalization during the period of the study
boolean
C3843040 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0019993 (UMLS CUI [1,3])
Medical condition Requirement CORTICOSTEROIDS FOR SYSTEMIC USE chronic | Medical condition Requirement TNF Blocker | 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])
C2343929 (UMLS CUI [2,3])
C3843040 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C0021081 (UMLS CUI [3,3])
Hepatitis, Chronic | Exception Etiology HCV | Nonalcoholic Steatohepatitis | Hepatitis, Drug-Induced | Hepatitis, Autoimmune
Item
has 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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