ID

39695

Description

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

Keywords

Versions (1)
  1. 2/10/20 2/10/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 10, 2020

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Hepatitis C, Chronic NCT01001754

English

Eligibility Hepatitis C, Chronic NCT01001754

1 forms  
Inclusion Criteria
Description

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
Description

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

Data type

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
Description

Hepatitis C Genotype

Data type

boolean

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

Hepatitis C virus RNA assay

Data type

boolean

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

Alanine aminotransferase measurement | Aspartate aminotransferase measurement

Data type

boolean

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

Liver Cirrhosis Absent

Data type

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
Description

Study Protocol Comprehension | Informed Consent

Data type

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
mixed genotype hcv infection
Description

Hepatitis C Genotype Mixed

Data type

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
Description

Decompensated liver disease

Data type

boolean

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

Investigational New Drugs Recent | DIRECT ACTING ANTIVIRALS Recent

Data type

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
Description

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

Data type

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
Description

Substance Use Disorders

Data type

boolean

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

Eligibility Criteria Study Protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348563
Back to the top of the page

Similar models

Eligibility Hepatitis C, Chronic NCT01001754

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial