ID

39695

Beschrijving

Efficacy and Safety Study of PEG-rIL-29 Plus Ribavirin to Treat Chronic Hepatitis C Virus Infection; ODM derived from: https://clinicaltrials.gov/show/NCT01001754

Link

https://clinicaltrials.gov/show/NCT01001754

Trefwoorden

Versies (1)
  1. 10-02-20 10-02-20 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

10 februari 2020

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Hepatitis C, Chronic NCT01001754

Engels

Eligibility Hepatitis C, Chronic NCT01001754

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
no prior therapy for chronic hcv, other than up to 2 weeks of single-agent therapy with a direct-acting antiviral agent, including but not limited to, a protease or polymerase inhibitor
Beschrijving

Prior Therapy Absent Chronic Hepatitis C | Exception DIRECT ACTING ANTIVIRAL Single | Exception Protease Inhibitor | Exception RNA Polymerase Inhibitor

Datatype

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0524910
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C3653501
UMLS CUI [2,3]
C0205171
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0033607
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C1514669
hcv genotype 1, 2, 3, or 4
Beschrijving

Hepatitis C Genotype

Datatype

boolean

Alias
UMLS CUI [1,1]
C0019196
UMLS CUI [1,2]
C1533728
hcv rna ≥100,000 iu/ml
Beschrijving

Hepatitis C virus RNA assay

Datatype

boolean

Alias
UMLS CUI [1]
C1272251
alt and ast ≤5.0 × uln
Beschrijving

Alanine aminotransferase measurement | Aspartate aminotransferase measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0201836
UMLS CUI [2]
C0201899
documented absence of cirrhosis
Beschrijving

Liver Cirrhosis Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0023890
UMLS CUI [1,2]
C0332197
able to comprehend the investigational nature of this study and sign an informed consent form
Beschrijving

Study Protocol Comprehension | Informed Consent

Datatype

boolean

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C0162340
UMLS CUI [2]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
mixed genotype hcv infection
Beschrijving

Hepatitis C Genotype Mixed

Datatype

boolean

Alias
UMLS CUI [1,1]
C0019196
UMLS CUI [1,2]
C4272868
UMLS CUI [1,3]
C0205430
current or prior history of decompensated liver disease
Beschrijving

Decompensated liver disease

Datatype

boolean

Alias
UMLS CUI [1]
C4075847
received any investigational drug, including a direct-acting antiviral agent, within 60 days prior to receiving study drug
Beschrijving

Investigational New Drugs Recent | DIRECT ACTING ANTIVIRALS Recent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C0332185
UMLS CUI [2,1]
C3653501
UMLS CUI [2,2]
C0332185
positive test for hepatitis b surface antigen, human immunodeficiency virus (hiv)-1, or hiv2 antibody at screening
Beschrijving

Hepatitis B surface antigen positive | HIV-1 antibody Positive | Serum antibody hiv-2 Positive

Datatype

boolean

Alias
UMLS CUI [1]
C0149709
UMLS CUI [2,1]
C0369497
UMLS CUI [2,2]
C1514241
UMLS CUI [3,1]
C3469372
UMLS CUI [3,2]
C1514241
active substance abuse, such as alcohol, or inhaled or injected drugs, within 6 months
Beschrijving

Substance Use Disorders

Datatype

boolean

Alias
UMLS CUI [1]
C0038586
additional inclusion and exclusion criteria are specified in the protocol.
Beschrijving

Eligibility Criteria Study Protocol

Datatype

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348563
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Similar models

Eligibility Hepatitis C, Chronic NCT01001754

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Prior Therapy Absent Chronic Hepatitis C | Exception DIRECT ACTING ANTIVIRAL Single | Exception Protease Inhibitor | Exception RNA Polymerase Inhibitor
Item
no prior therapy for chronic hcv, other than up to 2 weeks of single-agent therapy with a direct-acting antiviral agent, including but not limited to, a protease or polymerase inhibitor
boolean
C1514463 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0524910 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C3653501 (UMLS CUI [2,2])
C0205171 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0033607 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C1514669 (UMLS CUI [4,2])
Hepatitis C Genotype
Item
hcv genotype 1, 2, 3, or 4
boolean
C0019196 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
Hepatitis C virus RNA assay
Item
hcv rna ≥100,000 iu/ml
boolean
C1272251 (UMLS CUI [1])
Alanine aminotransferase measurement | Aspartate aminotransferase measurement
Item
alt and ast ≤5.0 × uln
boolean
C0201836 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
Liver Cirrhosis Absent
Item
documented absence of cirrhosis
boolean
C0023890 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Study Protocol Comprehension | Informed Consent
Item
able to comprehend the investigational nature of this study and sign an informed consent form
boolean
C2348563 (UMLS CUI [1,1])
C0162340 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Hepatitis C Genotype Mixed
Item
mixed genotype hcv infection
boolean
C0019196 (UMLS CUI [1,1])
C4272868 (UMLS CUI [1,2])
C0205430 (UMLS CUI [1,3])
Decompensated liver disease
Item
current or prior history of decompensated liver disease
boolean
C4075847 (UMLS CUI [1])
Investigational New Drugs Recent | DIRECT ACTING ANTIVIRALS Recent
Item
received any investigational drug, including a direct-acting antiviral agent, within 60 days prior to receiving study drug
boolean
C0013230 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C3653501 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
Hepatitis B surface antigen positive | HIV-1 antibody Positive | Serum antibody hiv-2 Positive
Item
positive test for hepatitis b surface antigen, human immunodeficiency virus (hiv)-1, or hiv2 antibody at screening
boolean
C0149709 (UMLS CUI [1])
C0369497 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
C3469372 (UMLS CUI [3,1])
C1514241 (UMLS CUI [3,2])
Substance Use Disorders
Item
active substance abuse, such as alcohol, or inhaled or injected drugs, within 6 months
boolean
C0038586 (UMLS CUI [1])
Eligibility Criteria Study Protocol
Item
additional inclusion and exclusion criteria are specified in the protocol.
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
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