ID

15267

Description

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

Link

https://clinicaltrials.gov/show/NCT02358044

Keywords

Versions (1)
  1. 5/24/16 5/24/16 -
Uploaded on

May 24, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatitis C NCT02358044

English

Eligibility Hepatitis C NCT02358044

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
weigh ≥ 40 kg and ≤125 kg
Description

Body Weight

Data type

boolean

Alias
UMLS CUI [1]
C0005910
documented chronic hcv gt1, gt4, or gt6 infection
Description

Chronic hepatitis C virus genotype 1 Communicable Diseases | Hepatitis C virus genotype 4 chronic Communicable Diseases | Hepatitis C virus genotype 6 chronic Communicable Diseases

Data type

boolean

Alias
UMLS CUI [1,1]
C3805156
UMLS CUI [1,2]
C0009450
UMLS CUI [2,1]
C3532922
UMLS CUI [2,2]
C0205191
UMLS CUI [2,3]
C0009450
UMLS CUI [3,1]
C3532924
UMLS CUI [3,2]
C0205191
UMLS CUI [3,3]
C0009450
cirrhosis/absence of cirrhosis defined by liver biopsy, fibroscan, or fibrosure®
Description

Liver Cirrhosis | Liver Cirrhosis Absent | Biopsy of liver | Fibrosure

Data type

boolean

Alias
UMLS CUI [1]
C0023890
UMLS CUI [2,1]
C0023890
UMLS CUI [2,2]
C0332197
UMLS CUI [3]
C0193388
UMLS CUI [4]
C1955263
either treatment naïve or pr null responder, pr partial responder, or pr prior relapser
Description

Therapy naive | PEGINTERFERON/RIBAVIRIN Therapy non-responder | PEGINTERFERON/RIBAVIRIN Partial responder to therapy | PEGINTERFERON/RIBAVIRIN Relapse Previous

Data type

boolean

Alias
UMLS CUI [1]
C0919936
UMLS CUI [2,1]
C1875630
UMLS CUI [2,2]
C0919875
UMLS CUI [3,1]
C1875630
UMLS CUI [3,2]
C1740822
UMLS CUI [4,1]
C1875630
UMLS CUI [4,2]
C0035020
UMLS CUI [4,3]
C0205156
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
Description

Contraceptive methods Willing | Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C0600109
UMLS CUI [2]
C0013230
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
has evidence of decompensated liver disease
Description

Decompensated cirrhosis

Data type

boolean

Alias
UMLS CUI [1]
C1619727
is coinfected with hepatitis b virus (e.g. hepatitis b surface antigen positive) or human immunodeficiency virus
Description

HBV coinfection | Hepatitis B surface antigen positive | Coinfection HIV

Data type

boolean

Alias
UMLS CUI [1]
C2242656
UMLS CUI [2]
C0149709
UMLS CUI [3,1]
C0275524
UMLS CUI [3,2]
C0019682
history of malignancy ≤5 years prior to signing informed consent, or is under evaluation for other active or suspected malignancy
Description

Malignant Neoplasms | Informed Consent | Evaluation Malignant Neoplasms

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0021430
UMLS CUI [3,1]
C0220825
UMLS CUI [3,2]
C0006826
has cirrhosis and liver imaging within 6 months of day 1 showing evidence of hepatocellular carcinoma (hcc) or is under evaluation for hcc
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C2239176
UMLS CUI [2]
C0023890
UMLS CUI [3]
C2711860
UMLS CUI [4,1]
C0220825
UMLS CUI [4,2]
C2239176
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
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C0021053
UMLS CUI [2]
C0029216
UMLS CUI [3]
C0010031
UMLS CUI [4]
C0018494
UMLS CUI [5]
C0577866
UMLS CUI [6]
C1292451
UMLS CUI [7]
C0192398
UMLS CUI [8]
C0024523
UMLS CUI [9,1]
C2825233
UMLS CUI [9,2]
C0205191
UMLS CUI [10,1]
C0019189
UMLS CUI [10,2]
C0015127
UMLS CUI [10,3]
C0220847
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Similar models

Eligibility Hepatitis C NCT02358044

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
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])
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])
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])
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])
Item Group
C0680251 (UMLS CUI)
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])
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])
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])
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])
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