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

Lien

https://clinicaltrials.gov/show/NCT01391117

Mots-clés

Versions (1)
  1. 03/06/2020 03/06/2020 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

3 juin 2020

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Hepatitis C Virus NCT01391117

Anglais

Eligibility Hepatitis C Virus NCT01391117

1 Formulaires  
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

Type de données

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

Type de données

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

Type de données

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

Type de données

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

Type de données

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

Type de données

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

Type de données

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

Type de données

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

Type de données

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

Type de données

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

Type de données

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

Type de données

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

Type de données

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

Type de données

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
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Similar models

Eligibility Hepatitis C Virus NCT01391117

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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])
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