ID

40910

Description

TMC649128HPC1002 - a Trial inGenotype 1 Hepatitis C Virus (HCV) - Infected Participants to Determine the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of TMC649128, Alone and Combined With Pegylated Interferon + Ribavirin; ODM derived from: https://clinicaltrials.gov/show/NCT01391117

Link

https://clinicaltrials.gov/show/NCT01391117

Keywords

Versions (1)
  1. 6/3/20 6/3/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 3, 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 :

  • Newest
  • Oldest
  • Popular
  • Newest
    • Newest
    • Oldest
    • Popular

No comments

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

Eligibility Hepatitis C Virus NCT01391117

English

Eligibility Hepatitis C Virus NCT01391117

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
documented chronic (> 6 months) genotype 1a or 1b hepatitis c virus (hcv) infection
Description

Chronic Hepatitis C Genotype

Data type

boolean

Alias
UMLS CUI [1,1]
C0524910
UMLS CUI [1,2]
C1533728
treatment-naive volunteer, meaning never received (peg)ifn, rbv or any other approved or investigational treatment for chronic hcv infection (panels 1, 2, 3 or 4) or volunteer is a documented prior non-responder or relapser subject to previous treatment regimens (ifn/rbv or pegylated ifn/rbv) but has stopped this treatment at least 6 months before screening
Description

Therapy naive | Interferon Absent Chronic Hepatitis C | PEGINTERFERON Absent Chronic Hepatitis C | Ribavirin Absent Chronic Hepatitis C | Investigational Therapy Absent Chronic Hepatitis C | Therapy non-responder | Relapse | Interferon | Ribavirin | PEGINTERFERON/RIBAVIRIN | Prior Therapy Discontinued

Data type

boolean

Alias
UMLS CUI [1]
C0919936
UMLS CUI [2,1]
C3652465
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0524910
UMLS CUI [3,1]
C0982327
UMLS CUI [3,2]
C0332197
UMLS CUI [3,3]
C0524910
UMLS CUI [4,1]
C0035525
UMLS CUI [4,2]
C0332197
UMLS CUI [4,3]
C0524910
UMLS CUI [5,1]
C0949266
UMLS CUI [5,2]
C0332197
UMLS CUI [5,3]
C0524910
UMLS CUI [6]
C0919875
UMLS CUI [7]
C0035020
UMLS CUI [8]
C3652465
UMLS CUI [9]
C0035525
UMLS CUI [10]
C1875630
UMLS CUI [11,1]
C1514463
UMLS CUI [11,2]
C1444662
volunteer has never received a hcv polymerase inhibitor and hcv protease inhibitor treatment was stopped since at least one year (panels 1, 2 or 3)
Description

HCV Polymerase Inhibitor Absent | HCV Protease Inhibitor Discontinued

Data type

boolean

Alias
UMLS CUI [1,1]
C0220847
UMLS CUI [1,2]
C1335439
UMLS CUI [1,3]
C1999216
UMLS CUI [1,4]
C0332197
UMLS CUI [2,1]
C0220847
UMLS CUI [2,2]
C0033607
UMLS CUI [2,3]
C1444662
volunteer with hcv plasma rna levels of > 100,000 iu/ml at screening
Description

Plasma Hepatitis C virus RNA assay

Data type

boolean

Alias
UMLS CUI [1,1]
C0032105
UMLS CUI [1,2]
C1272251
body mass index of 18.0 to 35.0 kg/m2
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
healthy based on a medical evaluation including medical history, physical examination, blood tests, vital signs, and electrocardiogram.
Description

Healthy Volunteer Evaluation | Medical History | Physical Examination | Hematologic Tests | Vital signs | Electrocardiography

Data type

boolean

Alias
UMLS CUI [1,1]
C1708335
UMLS CUI [1,2]
C1261322
UMLS CUI [2]
C0262926
UMLS CUI [3]
C0031809
UMLS CUI [4]
C0018941
UMLS CUI [5]
C0518766
UMLS CUI [6]
C1623258
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
evidence of liver cirrhosis
Description

Liver Cirrhosis

Data type

boolean

Alias
UMLS CUI [1]
C0023890
historical liver biopsy graded as liver cirrhosis or evidence for the presence of oesophageal varices or a transient elastography (fibroscan) result of more than 14.6 kpa within 2 years prior to screening
Description

Liver Cirrhosis Biopsy of liver | Esophageal Varices | Fibroscan Result

Data type

boolean

Alias
UMLS CUI [1,1]
C0023890
UMLS CUI [1,2]
C0193388
UMLS CUI [2]
C0014867
UMLS CUI [3,1]
C4522043
UMLS CUI [3,2]
C1274040
evidence of decompensated liver disease defined as prior history or current evidence of ascites, hepatic encephalopathy, bleeding oesophageal or gastric varices
Description

Decompensated liver disease | Ascites | Hepatic Encephalopathy | Bleeding esophageal varices | Bleeding gastric varices

Data type

boolean

Alias
UMLS CUI [1]
C4075847
UMLS CUI [2]
C0003962
UMLS CUI [3]
C0019151
UMLS CUI [4]
C0155789
UMLS CUI [5]
C0267209
evidence of renal dysfunction, documented by an estimated creatinine clearance below 70 ml/min
Description

Renal dysfunction | Estimated creatinine clearance

Data type

boolean

Alias
UMLS CUI [1]
C3279454
UMLS CUI [2]
C1273051
evidence of any other cause of significant liver disease in addition to hepatitis c, this may include but is not limited to hepatitis b, drug- or alcohol-related cirrhosis, autoimmune hepatitis, hemochromatosis, wilson's disease, non-alcoholic steatohepatitis, or primary biliary cirrhosis
Description

Liver disease In addition to Hepatitis C | Etiology aspects | Hepatitis B | Drug-induced cirrhosis of liver | Liver Cirrhosis, Alcoholic | Hepatitis, Autoimmune | Hemochromatosis | Hepatolenticular Degeneration | Nonalcoholic Steatohepatitis | Primary biliary cirrhosis

Data type

boolean

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0332287
UMLS CUI [1,3]
C0019196
UMLS CUI [2]
C0015127
UMLS CUI [3]
C0019163
UMLS CUI [4]
C1960179
UMLS CUI [5]
C0023891
UMLS CUI [6]
C0241910
UMLS CUI [7]
C0018995
UMLS CUI [8]
C0019202
UMLS CUI [9]
C3241937
UMLS CUI [10]
C0008312
volunteer with diagnosed or suspected hepatocellular carcinoma
Description

Liver carcinoma | Liver carcinoma Suspected

Data type

boolean

Alias
UMLS CUI [1]
C2239176
UMLS CUI [2,1]
C2239176
UMLS CUI [2,2]
C0750491
volunteer receiving or having received any treatment for hcv during the 6 months before screening
Description

Therapy Hepatitis C

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0019196
volunteer coinfected with human immunodeficiency virus-1 (hiv-1) or hiv-2, or hepatitis a or b virus infection, or clinically active tuberculosis at study screening.
Description

Coinfection HIV-1 | Coinfection HIV-2 | Hepatitis A | Hepatitis B | Tuberculosis

Data type

boolean

Alias
UMLS CUI [1,1]
C0275524
UMLS CUI [1,2]
C0019704
UMLS CUI [2,1]
C0275524
UMLS CUI [2,2]
C0019707
UMLS CUI [3]
C0019159
UMLS CUI [4]
C0019163
UMLS CUI [5]
C0041296
Back to the top of the page

Similar models

Eligibility Hepatitis C Virus NCT01391117

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Chronic Hepatitis C Genotype
Item
documented chronic (> 6 months) genotype 1a or 1b hepatitis c virus (hcv) infection
boolean
C0524910 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
Therapy naive | Interferon Absent Chronic Hepatitis C | PEGINTERFERON Absent Chronic Hepatitis C | Ribavirin Absent Chronic Hepatitis C | Investigational Therapy Absent Chronic Hepatitis C | Therapy non-responder | Relapse | Interferon | Ribavirin | PEGINTERFERON/RIBAVIRIN | Prior Therapy Discontinued
Item
treatment-naive volunteer, meaning never received (peg)ifn, rbv or any other approved or investigational treatment for chronic hcv infection (panels 1, 2, 3 or 4) or volunteer is a documented prior non-responder or relapser subject to previous treatment regimens (ifn/rbv or pegylated ifn/rbv) but has stopped this treatment at least 6 months before screening
boolean
C0919936 (UMLS CUI [1])
C3652465 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0524910 (UMLS CUI [2,3])
C0982327 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0524910 (UMLS CUI [3,3])
C0035525 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0524910 (UMLS CUI [4,3])
C0949266 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C0524910 (UMLS CUI [5,3])
C0919875 (UMLS CUI [6])
C0035020 (UMLS CUI [7])
C3652465 (UMLS CUI [8])
C0035525 (UMLS CUI [9])
C1875630 (UMLS CUI [10])
C1514463 (UMLS CUI [11,1])
C1444662 (UMLS CUI [11,2])
HCV Polymerase Inhibitor Absent | HCV Protease Inhibitor Discontinued
Item
volunteer has never received a hcv polymerase inhibitor and hcv protease inhibitor treatment was stopped since at least one year (panels 1, 2 or 3)
boolean
C0220847 (UMLS CUI [1,1])
C1335439 (UMLS CUI [1,2])
C1999216 (UMLS CUI [1,3])
C0332197 (UMLS CUI [1,4])
C0220847 (UMLS CUI [2,1])
C0033607 (UMLS CUI [2,2])
C1444662 (UMLS CUI [2,3])
Plasma Hepatitis C virus RNA assay
Item
volunteer with hcv plasma rna levels of > 100,000 iu/ml at screening
boolean
C0032105 (UMLS CUI [1,1])
C1272251 (UMLS CUI [1,2])
Body mass index
Item
body mass index of 18.0 to 35.0 kg/m2
boolean
C1305855 (UMLS CUI [1])
Healthy Volunteer Evaluation | Medical History | Physical Examination | Hematologic Tests | Vital signs | Electrocardiography
Item
healthy based on a medical evaluation including medical history, physical examination, blood tests, vital signs, and electrocardiogram.
boolean
C1708335 (UMLS CUI [1,1])
C1261322 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2])
C0031809 (UMLS CUI [3])
C0018941 (UMLS CUI [4])
C0518766 (UMLS CUI [5])
C1623258 (UMLS CUI [6])
Item Group
C0680251 (UMLS CUI)
Liver Cirrhosis
Item
evidence of liver cirrhosis
boolean
C0023890 (UMLS CUI [1])
Liver Cirrhosis Biopsy of liver | Esophageal Varices | Fibroscan Result
Item
historical liver biopsy graded as liver cirrhosis or evidence for the presence of oesophageal varices or a transient elastography (fibroscan) result of more than 14.6 kpa within 2 years prior to screening
boolean
C0023890 (UMLS CUI [1,1])
C0193388 (UMLS CUI [1,2])
C0014867 (UMLS CUI [2])
C4522043 (UMLS CUI [3,1])
C1274040 (UMLS CUI [3,2])
Decompensated liver disease | Ascites | Hepatic Encephalopathy | Bleeding esophageal varices | Bleeding gastric varices
Item
evidence of decompensated liver disease defined as prior history or current evidence of ascites, hepatic encephalopathy, bleeding oesophageal or gastric varices
boolean
C4075847 (UMLS CUI [1])
C0003962 (UMLS CUI [2])
C0019151 (UMLS CUI [3])
C0155789 (UMLS CUI [4])
C0267209 (UMLS CUI [5])
Renal dysfunction | Estimated creatinine clearance
Item
evidence of renal dysfunction, documented by an estimated creatinine clearance below 70 ml/min
boolean
C3279454 (UMLS CUI [1])
C1273051 (UMLS CUI [2])
Liver disease In addition to Hepatitis C | Etiology aspects | Hepatitis B | Drug-induced cirrhosis of liver | Liver Cirrhosis, Alcoholic | Hepatitis, Autoimmune | Hemochromatosis | Hepatolenticular Degeneration | Nonalcoholic Steatohepatitis | Primary biliary cirrhosis
Item
evidence of any other cause of significant liver disease in addition to hepatitis c, this may include but is not limited to hepatitis b, drug- or alcohol-related cirrhosis, autoimmune hepatitis, hemochromatosis, wilson's disease, non-alcoholic steatohepatitis, or primary biliary cirrhosis
boolean
C0023895 (UMLS CUI [1,1])
C0332287 (UMLS CUI [1,2])
C0019196 (UMLS CUI [1,3])
C0015127 (UMLS CUI [2])
C0019163 (UMLS CUI [3])
C1960179 (UMLS CUI [4])
C0023891 (UMLS CUI [5])
C0241910 (UMLS CUI [6])
C0018995 (UMLS CUI [7])
C0019202 (UMLS CUI [8])
C3241937 (UMLS CUI [9])
C0008312 (UMLS CUI [10])
Liver carcinoma | Liver carcinoma Suspected
Item
volunteer with diagnosed or suspected hepatocellular carcinoma
boolean
C2239176 (UMLS CUI [1])
C2239176 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
Therapy Hepatitis C
Item
volunteer receiving or having received any treatment for hcv during the 6 months before screening
boolean
C0087111 (UMLS CUI [1,1])
C0019196 (UMLS CUI [1,2])
Coinfection HIV-1 | Coinfection HIV-2 | Hepatitis A | Hepatitis B | Tuberculosis
Item
volunteer coinfected with human immunodeficiency virus-1 (hiv-1) or hiv-2, or hepatitis a or b virus infection, or clinically active tuberculosis at study screening.
boolean
C0275524 (UMLS CUI [1,1])
C0019704 (UMLS CUI [1,2])
C0275524 (UMLS CUI [2,1])
C0019707 (UMLS CUI [2,2])
C0019159 (UMLS CUI [3])
C0019163 (UMLS CUI [4])
C0041296 (UMLS CUI [5])
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