ID

39724

Description

This Trial Evaluates Safety, Pharmacokinetic Profile and Anti-viral Response of BI 207127 and BI 201335 for Patients With Chronic Hepatitis C; ODM derived from: https://clinicaltrials.gov/show/NCT01528735

Link

https://clinicaltrials.gov/show/NCT01528735

Keywords

Versions (1)
  1. 2/12/20 2/12/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 12, 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 NCT01528735

English

Eligibility Hepatitis C, Chronic NCT01528735

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
chronic hepatitis c, diagnosed by positive anti-hepatitis c virus(hcv) antibodies and detected hcv ribonucleic acid(rna) at screening in addition to:
Description

Hepatitis C, Chronic | Hepatitis C Antibodies Positive | Hepatitis C virus RNA Detected

Data type

boolean

Alias
UMLS CUI [1]
C0524910
UMLS CUI [2,1]
C0166049
UMLS CUI [2,2]
C1514241
UMLS CUI [3,1]
C0369335
UMLS CUI [3,2]
C0442726
1. positive anti-hcv antibodies or detected hcv rna at least 6 months prior to screening; or,
Description

Hepatitis C Antibodies Positive Timespan | Hepatitis C virus RNA Detected Timespan

Data type

boolean

Alias
UMLS CUI [1,1]
C0166049
UMLS CUI [1,2]
C1514241
UMLS CUI [1,3]
C0872291
UMLS CUI [2,1]
C0369335
UMLS CUI [2,2]
C0442726
UMLS CUI [2,3]
C0872291
2. liver biopsy consistent with chronic hcv infection.
Description

Biopsy of liver Consistent with Chronic Hepatitis C

Data type

boolean

Alias
UMLS CUI [1,1]
C0193388
UMLS CUI [1,2]
C0332290
UMLS CUI [1,3]
C0524910
hcv infection of genotype 1 confirmed by genotypic testing at screening
Description

Hepatitis C Genotype | Hepatitis virus genotyping

Data type

boolean

Alias
UMLS CUI [1,1]
C0019196
UMLS CUI [1,2]
C1533728
UMLS CUI [2]
C2368162
therapy-naïve to interferon, pegylated interferon, ribavirin or any antiviral /
Description

Interferon Absent | PEGINTERFERON Absent | Ribavirin Absent | Antiviral Agents Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C3652465
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0982327
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0035525
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0003451
UMLS CUI [4,2]
C0332197
immunomodulatory drug for acute or chronic hcv infection.
Description

Immunomodulatory agent Hepatitis C | Immunomodulatory agent Chronic Hepatitis C

Data type

boolean

Alias
UMLS CUI [1,1]
C0005525
UMLS CUI [1,2]
C0019196
UMLS CUI [2,1]
C0005525
UMLS CUI [2,2]
C0524910
plasma hcv rna = 100,000 iu/ml at screening
Description

Hepatitis C virus RNA assay Plasma

Data type

boolean

Alias
UMLS CUI [1,1]
C1272251
UMLS CUI [1,2]
C0032105
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
hepatitis c infection of mixed genotype (1/2, 1/3, and 1/4) diagnosed by genotypic testing at screening
Description

Hepatitis C Genotype Mixed | Hepatitis virus genotyping

Data type

boolean

Alias
UMLS CUI [1,1]
C0019196
UMLS CUI [1,2]
C4272868
UMLS CUI [1,3]
C0205430
UMLS CUI [2]
C2368162
human immunodeficiency virus (hiv) co-infection
Description

Human immunodeficiency virus (HIV) coinfection

Data type

boolean

Alias
UMLS CUI [1]
C4062778
decompensated liver disease, or history of decompensated liver disease
Description

Decompensated liver disease

Data type

boolean

Alias
UMLS CUI [1]
C4075847
body weight < 40 or > 125 kg at screening
Description

Body Weight

Data type

boolean

Alias
UMLS CUI [1]
C0005910
hemoglobin <12.0g/dl for women and <13.0g/dl for men at screening
Description

Hemoglobin measurement | Gender

Data type

boolean

Alias
UMLS CUI [1]
C0518015
UMLS CUI [2]
C0079399
white blood cell count <3000 cells/mm3 at screening
Description

White Blood Cell Count procedure

Data type

boolean

Alias
UMLS CUI [1]
C0023508
absolute neutrophil count < 1,500 cells/mm3 at screening
Description

Absolute neutrophil count

Data type

boolean

Alias
UMLS CUI [1]
C0948762
platelet count < 90,000 /mm3 at screening
Description

Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0032181
serum creatinine > 1.5xupper limit of normal range(uln) or creatinine clearance =50 ml/min at screening
Description

Serum creatinine raised | Creatinine clearance measurement

Data type

boolean

Alias
UMLS CUI [1]
C0700225
UMLS CUI [2]
C0373595
Back to the top of the page

Similar models

Eligibility Hepatitis C, Chronic NCT01528735

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Hepatitis C, Chronic | Hepatitis C Antibodies Positive | Hepatitis C virus RNA Detected
Item
chronic hepatitis c, diagnosed by positive anti-hepatitis c virus(hcv) antibodies and detected hcv ribonucleic acid(rna) at screening in addition to:
boolean
C0524910 (UMLS CUI [1])
C0166049 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
C0369335 (UMLS CUI [3,1])
C0442726 (UMLS CUI [3,2])
Hepatitis C Antibodies Positive Timespan | Hepatitis C virus RNA Detected Timespan
Item
1. positive anti-hcv antibodies or detected hcv rna at least 6 months prior to screening; or,
boolean
C0166049 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
C0872291 (UMLS CUI [1,3])
C0369335 (UMLS CUI [2,1])
C0442726 (UMLS CUI [2,2])
C0872291 (UMLS CUI [2,3])
Biopsy of liver Consistent with Chronic Hepatitis C
Item
2. liver biopsy consistent with chronic hcv infection.
boolean
C0193388 (UMLS CUI [1,1])
C0332290 (UMLS CUI [1,2])
C0524910 (UMLS CUI [1,3])
Hepatitis C Genotype | Hepatitis virus genotyping
Item
hcv infection of genotype 1 confirmed by genotypic testing at screening
boolean
C0019196 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
C2368162 (UMLS CUI [2])
Interferon Absent | PEGINTERFERON Absent | Ribavirin Absent | Antiviral Agents Absent
Item
therapy-naïve to interferon, pegylated interferon, ribavirin or any antiviral /
boolean
C3652465 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0982327 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0035525 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0003451 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Immunomodulatory agent Hepatitis C | Immunomodulatory agent Chronic Hepatitis C
Item
immunomodulatory drug for acute or chronic hcv infection.
boolean
C0005525 (UMLS CUI [1,1])
C0019196 (UMLS CUI [1,2])
C0005525 (UMLS CUI [2,1])
C0524910 (UMLS CUI [2,2])
Hepatitis C virus RNA assay Plasma
Item
plasma hcv rna = 100,000 iu/ml at screening
boolean
C1272251 (UMLS CUI [1,1])
C0032105 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Hepatitis C Genotype Mixed | Hepatitis virus genotyping
Item
hepatitis c infection of mixed genotype (1/2, 1/3, and 1/4) diagnosed by genotypic testing at screening
boolean
C0019196 (UMLS CUI [1,1])
C4272868 (UMLS CUI [1,2])
C0205430 (UMLS CUI [1,3])
C2368162 (UMLS CUI [2])
Human immunodeficiency virus (HIV) coinfection
Item
human immunodeficiency virus (hiv) co-infection
boolean
C4062778 (UMLS CUI [1])
Decompensated liver disease
Item
decompensated liver disease, or history of decompensated liver disease
boolean
C4075847 (UMLS CUI [1])
Body Weight
Item
body weight < 40 or > 125 kg at screening
boolean
C0005910 (UMLS CUI [1])
Hemoglobin measurement | Gender
Item
hemoglobin <12.0g/dl for women and <13.0g/dl for men at screening
boolean
C0518015 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
White Blood Cell Count procedure
Item
white blood cell count <3000 cells/mm3 at screening
boolean
C0023508 (UMLS CUI [1])
Absolute neutrophil count
Item
absolute neutrophil count < 1,500 cells/mm3 at screening
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
platelet count < 90,000 /mm3 at screening
boolean
C0032181 (UMLS CUI [1])
Serum creatinine raised | Creatinine clearance measurement
Item
serum creatinine > 1.5xupper limit of normal range(uln) or creatinine clearance =50 ml/min at screening
boolean
C0700225 (UMLS CUI [1])
C0373595 (UMLS CUI [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