ID

39679

Beschreibung

Efficacy and Safety of Grazoprevir (MK-5172), Elbasvir (MK-8742), and Sofosbuvir for Chronic Infection With Hepatitis C Virus Genotypes 1 and 3 (MK-5172-074); ODM derived from: https://clinicaltrials.gov/show/NCT02133131

Link

https://clinicaltrials.gov/show/NCT02133131

Stichworte

Versionen (1)
  1. 09.02.20 09.02.20 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

9. Februar 2020

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Hepatitis C NCT02133131

Englisch

Eligibility Hepatitis C NCT02133131

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
has hcv rna ≥10,000 iu/ml in peripheral blood at the time of screening
Beschreibung

Hepatitis C virus RNA assay Peripheral blood

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1272251
UMLS CUI [1,2]
C0229664
has documented chronic hcv gt1 or gt3 infection
Beschreibung

Chronic Hepatitis C Genotype

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0524910
UMLS CUI [1,2]
C1533728
has either negative or positive history of liver cirrhosis based on liver biopsy, fibroscan, or fibrosure ® (fibrotest®)
Beschreibung

Liver Cirrhosis Negative Biopsy of liver | Liver Cirrhosis Positive Biopsy of liver | Liver Cirrhosis Negative Fibroscan | Liver Cirrhosis Positive Fibroscan | Liver Cirrhosis Negative Fibrosure | Liver Cirrhosis Positive Fibrosure | Liver Cirrhosis Negative FibroTest Score Measurement | Liver Cirrhosis Positive FibroTest Score Measurement

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0023890
UMLS CUI [1,2]
C1513916
UMLS CUI [1,3]
C0193388
UMLS CUI [2,1]
C0023890
UMLS CUI [2,2]
C1514241
UMLS CUI [2,3]
C0193388
UMLS CUI [3,1]
C0023890
UMLS CUI [3,2]
C1513916
UMLS CUI [3,3]
C4522043
UMLS CUI [4,1]
C0023890
UMLS CUI [4,2]
C1514241
UMLS CUI [4,3]
C4522043
UMLS CUI [5,1]
C0023890
UMLS CUI [5,2]
C1513916
UMLS CUI [5,3]
C1955263
UMLS CUI [6,1]
C0023890
UMLS CUI [6,2]
C1514241
UMLS CUI [6,3]
C1955263
UMLS CUI [7,1]
C0023890
UMLS CUI [7,2]
C1513916
UMLS CUI [7,3]
C3642160
UMLS CUI [8,1]
C0023890
UMLS CUI [8,2]
C1514241
UMLS CUI [8,3]
C3642160
is treatment naïve to all anti-hcv treatment
Beschreibung

Anti-hepatitis C (HCV) Agents Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C4324240
UMLS CUI [1,2]
C0332197
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
has evidence of decompensated liver disease
Beschreibung

Decompensated liver disease

Datentyp

boolean

Alias
UMLS CUI [1]
C4075847
is coinfected with hepatitis b virus (e.g. hepatitis b surface antigen positive) or human immunodeficiency virus
Beschreibung

HBV coinfection | Hepatitis B surface antigen positive | Human immunodeficiency virus (HIV) coinfection

Datentyp

boolean

Alias
UMLS CUI [1]
C2242656
UMLS CUI [2]
C0149709
UMLS CUI [3]
C4062778
has a history of malignancy ≤5 years prior to signing informed consent, or is under evaluation for other active or suspected malignancy
Beschreibung

Malignant Neoplasms | Evaluation Malignant Neoplasm | Evaluation Malignant Neoplasm Suspected

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1261322
UMLS CUI [2,2]
C0006826
UMLS CUI [3,1]
C1261322
UMLS CUI [3,2]
C0006826
UMLS CUI [3,3]
C0750491
has cirrhosis and liver imaging within 6 months of day 1 showing evidence of hepatocellular carcinoma (hcc) or is under evaluation for hcc
Beschreibung

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

Datentyp

boolean

Alias
UMLS CUI [1]
C0023890
UMLS CUI [2,1]
C2239176
UMLS CUI [2,2]
C2711860
UMLS CUI [3,1]
C1261322
UMLS CUI [3,2]
C2239176
has clinically-relevant drug or alcohol abuse within 12 months of screening
Beschreibung

Substance Use Disorders

Datentyp

boolean

Alias
UMLS CUI [1]
C0038586
has any of the following conditions: organ transplants other than cornea and hair, poor venous access that precludes routine peripheral blood sampling, history of gastric surgery or malabsorption disorders, or any medical condition requiring, or likely to require, chronic systemic administration of corticosteroids during the course of the trial
Beschreibung

Organ Transplantation | Exception Cornea transplant | Exception Hair transplant | Poor venous access Excludes Peripheral blood Sampling | Operation on stomach | Malabsorption Syndrome | Medical condition Requirement CORTICOSTEROIDS FOR SYSTEMIC USE

Datentyp

boolean

Alias
UMLS CUI [1]
C0029216
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1384683
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0191626
UMLS CUI [4,1]
C0577866
UMLS CUI [4,2]
C0332196
UMLS CUI [4,3]
C0229664
UMLS CUI [4,4]
C0870078
UMLS CUI [5]
C0192398
UMLS CUI [6]
C0024523
UMLS CUI [7,1]
C3843040
UMLS CUI [7,2]
C1514873
UMLS CUI [7,3]
C3653708
has a history of chronic hepatitis not caused by hcv
Beschreibung

Hepatitis, Chronic | Etiology Except Hepatitis C virus

Datentyp

boolean

Alias
UMLS CUI [1]
C0019189
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0332300
UMLS CUI [2,3]
C0220847
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Ähnliche Modelle

Eligibility Hepatitis C NCT02133131

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Hepatitis C virus RNA assay Peripheral blood
Item
has hcv rna ≥10,000 iu/ml in peripheral blood at the time of screening
boolean
C1272251 (UMLS CUI [1,1])
C0229664 (UMLS CUI [1,2])
Chronic Hepatitis C Genotype
Item
has documented chronic hcv gt1 or gt3 infection
boolean
C0524910 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
Liver Cirrhosis Negative Biopsy of liver | Liver Cirrhosis Positive Biopsy of liver | Liver Cirrhosis Negative Fibroscan | Liver Cirrhosis Positive Fibroscan | Liver Cirrhosis Negative Fibrosure | Liver Cirrhosis Positive Fibrosure | Liver Cirrhosis Negative FibroTest Score Measurement | Liver Cirrhosis Positive FibroTest Score Measurement
Item
has either negative or positive history of liver cirrhosis based on liver biopsy, fibroscan, or fibrosure ® (fibrotest®)
boolean
C0023890 (UMLS CUI [1,1])
C1513916 (UMLS CUI [1,2])
C0193388 (UMLS CUI [1,3])
C0023890 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
C0193388 (UMLS CUI [2,3])
C0023890 (UMLS CUI [3,1])
C1513916 (UMLS CUI [3,2])
C4522043 (UMLS CUI [3,3])
C0023890 (UMLS CUI [4,1])
C1514241 (UMLS CUI [4,2])
C4522043 (UMLS CUI [4,3])
C0023890 (UMLS CUI [5,1])
C1513916 (UMLS CUI [5,2])
C1955263 (UMLS CUI [5,3])
C0023890 (UMLS CUI [6,1])
C1514241 (UMLS CUI [6,2])
C1955263 (UMLS CUI [6,3])
C0023890 (UMLS CUI [7,1])
C1513916 (UMLS CUI [7,2])
C3642160 (UMLS CUI [7,3])
C0023890 (UMLS CUI [8,1])
C1514241 (UMLS CUI [8,2])
C3642160 (UMLS CUI [8,3])
Anti-hepatitis C (HCV) Agents Absent
Item
is treatment naïve to all anti-hcv treatment
boolean
C4324240 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Decompensated liver disease
Item
has evidence of decompensated liver disease
boolean
C4075847 (UMLS CUI [1])
HBV coinfection | Hepatitis B surface antigen positive | Human immunodeficiency virus (HIV) coinfection
Item
is coinfected with hepatitis b virus (e.g. hepatitis b surface antigen positive) or human immunodeficiency virus
boolean
C2242656 (UMLS CUI [1])
C0149709 (UMLS CUI [2])
C4062778 (UMLS CUI [3])
Malignant Neoplasms | Evaluation Malignant Neoplasm | Evaluation Malignant Neoplasm Suspected
Item
has a history of malignancy ≤5 years prior to signing informed consent, or is under evaluation for other active or suspected malignancy
boolean
C0006826 (UMLS CUI [1])
C1261322 (UMLS CUI [2,1])
C0006826 (UMLS CUI [2,2])
C1261322 (UMLS CUI [3,1])
C0006826 (UMLS CUI [3,2])
C0750491 (UMLS CUI [3,3])
Liver Cirrhosis | Liver carcinoma Imaging of liver | 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])
C2239176 (UMLS CUI [2,1])
C2711860 (UMLS CUI [2,2])
C1261322 (UMLS CUI [3,1])
C2239176 (UMLS CUI [3,2])
Substance Use Disorders
Item
has clinically-relevant drug or alcohol abuse within 12 months of screening
boolean
C0038586 (UMLS CUI [1])
Organ Transplantation | Exception Cornea transplant | Exception Hair transplant | Poor venous access Excludes Peripheral blood Sampling | Operation on stomach | Malabsorption Syndrome | Medical condition Requirement CORTICOSTEROIDS FOR SYSTEMIC USE
Item
has any of the following conditions: organ transplants other than cornea and hair, poor venous access that precludes routine peripheral blood sampling, history of gastric surgery or malabsorption disorders, or any medical condition requiring, or likely to require, chronic systemic administration of corticosteroids during the course of the trial
boolean
C0029216 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1384683 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0191626 (UMLS CUI [3,2])
C0577866 (UMLS CUI [4,1])
C0332196 (UMLS CUI [4,2])
C0229664 (UMLS CUI [4,3])
C0870078 (UMLS CUI [4,4])
C0192398 (UMLS CUI [5])
C0024523 (UMLS CUI [6])
C3843040 (UMLS CUI [7,1])
C1514873 (UMLS CUI [7,2])
C3653708 (UMLS CUI [7,3])
Hepatitis, Chronic | Etiology Except Hepatitis C virus
Item
has a history of chronic hepatitis not caused by hcv
boolean
C0019189 (UMLS CUI [1])
C0015127 (UMLS CUI [2,1])
C0332300 (UMLS CUI [2,2])
C0220847 (UMLS CUI [2,3])
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