Information:
Fel:
ID
15267
Beskrivning
Efficacy and Safety of Combination Grazoprevir (MK-5172)/Elbasvir (MK-8742) Versus Sofosbuvir + Pegylated Interferon + Ribavirin in Hepatitis C Virus Genotype 1, 4 or 6 Infection; ODM derived from: https://clinicaltrials.gov/show/NCT02358044
Länk
https://clinicaltrials.gov/show/NCT02358044
Nyckelord
Versioner (1)
- 2016-05-24 2016-05-24 -
Uppladdad den
24 maj 2016
DOI
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Licens
Creative Commons BY 4.0
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Eligibility Hepatitis C NCT02358044
Eligibility Hepatitis C NCT02358044
- StudyEvent: Eligibility
Similar models
Eligibility Hepatitis C NCT02358044
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Body Weight
Item
weigh ≥ 40 kg and ≤125 kg
boolean
C0005910 (UMLS CUI [1])
Chronic hepatitis C virus genotype 1 Communicable Diseases | Hepatitis C virus genotype 4 chronic Communicable Diseases | Hepatitis C virus genotype 6 chronic Communicable Diseases
Item
documented chronic hcv gt1, gt4, or gt6 infection
boolean
C3805156 (UMLS CUI [1,1])
C0009450 (UMLS CUI [1,2])
C3532922 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C0009450 (UMLS CUI [2,3])
C3532924 (UMLS CUI [3,1])
C0205191 (UMLS CUI [3,2])
C0009450 (UMLS CUI [3,3])
C0009450 (UMLS CUI [1,2])
C3532922 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C0009450 (UMLS CUI [2,3])
C3532924 (UMLS CUI [3,1])
C0205191 (UMLS CUI [3,2])
C0009450 (UMLS CUI [3,3])
Liver Cirrhosis | Liver Cirrhosis Absent | Biopsy of liver | Fibrosure
Item
cirrhosis/absence of cirrhosis defined by liver biopsy, fibroscan, or fibrosure®
boolean
C0023890 (UMLS CUI [1])
C0023890 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0193388 (UMLS CUI [3])
C1955263 (UMLS CUI [4])
C0023890 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0193388 (UMLS CUI [3])
C1955263 (UMLS CUI [4])
Therapy naive | PEGINTERFERON/RIBAVIRIN Therapy non-responder | PEGINTERFERON/RIBAVIRIN Partial responder to therapy | PEGINTERFERON/RIBAVIRIN Relapse Previous
Item
either treatment naïve or pr null responder, pr partial responder, or pr prior relapser
boolean
C0919936 (UMLS CUI [1])
C1875630 (UMLS CUI [2,1])
C0919875 (UMLS CUI [2,2])
C1875630 (UMLS CUI [3,1])
C1740822 (UMLS CUI [3,2])
C1875630 (UMLS CUI [4,1])
C0035020 (UMLS CUI [4,2])
C0205156 (UMLS CUI [4,3])
C1875630 (UMLS CUI [2,1])
C0919875 (UMLS CUI [2,2])
C1875630 (UMLS CUI [3,1])
C1740822 (UMLS CUI [3,2])
C1875630 (UMLS CUI [4,1])
C0035020 (UMLS CUI [4,2])
C0205156 (UMLS CUI [4,3])
Contraceptive methods Willing | Investigational New Drugs
Item
participant and partner both agree to use at least use at least 2 effective methods of contraception from at least 2 weeks prior to day 1 and continue until up to 6 months after last dose of study drug, or longer if dictated by local regulations
boolean
C0700589 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
C0013230 (UMLS CUI [2])
C0600109 (UMLS CUI [1,2])
C0013230 (UMLS CUI [2])
Decompensated cirrhosis
Item
has evidence of decompensated liver disease
boolean
C1619727 (UMLS CUI [1])
HBV coinfection | Hepatitis B surface antigen positive | Coinfection HIV
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])
C0275524 (UMLS CUI [3,1])
C0019682 (UMLS CUI [3,2])
C0149709 (UMLS CUI [2])
C0275524 (UMLS CUI [3,1])
C0019682 (UMLS CUI [3,2])
Malignant Neoplasms | Informed Consent | Evaluation Malignant Neoplasms
Item
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])
C0021430 (UMLS CUI [2])
C0220825 (UMLS CUI [3,1])
C0006826 (UMLS CUI [3,2])
C0021430 (UMLS CUI [2])
C0220825 (UMLS CUI [3,1])
C0006826 (UMLS CUI [3,2])
Liver carcinoma | Liver Cirrhosis | 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
C2239176 (UMLS CUI [1])
C0023890 (UMLS CUI [2])
C2711860 (UMLS CUI [3])
C0220825 (UMLS CUI [4,1])
C2239176 (UMLS CUI [4,2])
C0023890 (UMLS CUI [2])
C2711860 (UMLS CUI [3])
C0220825 (UMLS CUI [4,1])
C2239176 (UMLS CUI [4,2])
Immune System Diseases | Organ Transplantation | Cornea | Hair | Poor venous access | Peripheral blood specimen | Operation on stomach | Malabsorption Syndrome | systemic steroids chronic | Hepatitis, Chronic Etiology aspects Hepatitis C virus
Item
has any of the following conditions: immunologically-mediated disease, 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, history of chronic hepatitis not caused by hcv
boolean
C0021053 (UMLS CUI [1])
C0029216 (UMLS CUI [2])
C0010031 (UMLS CUI [3])
C0018494 (UMLS CUI [4])
C0577866 (UMLS CUI [5])
C1292451 (UMLS CUI [6])
C0192398 (UMLS CUI [7])
C0024523 (UMLS CUI [8])
C2825233 (UMLS CUI [9,1])
C0205191 (UMLS CUI [9,2])
C0019189 (UMLS CUI [10,1])
C0015127 (UMLS CUI [10,2])
C0220847 (UMLS CUI [10,3])
C0029216 (UMLS CUI [2])
C0010031 (UMLS CUI [3])
C0018494 (UMLS CUI [4])
C0577866 (UMLS CUI [5])
C1292451 (UMLS CUI [6])
C0192398 (UMLS CUI [7])
C0024523 (UMLS CUI [8])
C2825233 (UMLS CUI [9,1])
C0205191 (UMLS CUI [9,2])
C0019189 (UMLS CUI [10,1])
C0015127 (UMLS CUI [10,2])
C0220847 (UMLS CUI [10,3])