ID

15273

Description

A Study to Assess the Efficacy and Safety of the Combination of Simeprevir and Daclatasvir in Chronic Hepatitis C Genotype 1b-Infected Participants; ODM derived from: https://clinicaltrials.gov/show/NCT02268864

Link

https://clinicaltrials.gov/show/NCT02268864

Keywords

Versions (3)
  1. 5/24/16 5/24/16 -
  2. 5/24/16 5/24/16 -
  3. 5/24/16 5/24/16 -
Uploaded on

May 24, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatitis C, Chronic NCT02268864

English

Eligibility Hepatitis C, Chronic NCT02268864

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
participant must have chronic hepatitis c virus (hcv) genotype 1b infection confirmed at screening
Description

Chronic infectious disease Hepatitis C virus genotype 1b

Data type

boolean

Alias
UMLS CUI [1,1]
C0151317
UMLS CUI [1,2]
C3495940
participant must have hcv ribonucleic acid (rna) greater than (>) 10,000 international unit per milliliter (iu/ml) at screening
Description

HCV viral load

Data type

boolean

Alias
UMLS CUI [1]
C1868902
participant must have documented fibrosis stage at screening (or between screening and day 1 [baseline]). liver disease will be staged based on one of the following methods. a) shear wave elastography (fibroscan) within less than or equal to (<=) 6 months before screening or between screening and day 1 (baseline). metavir f3 > 9.6 kilopascals (kpa) and the cut-off for cirrhosis is greater than or equal to (>=) 14.6 kpa. b) a biopsy documenting metavir f3-f4. biopsy performed within the 24 months before screening will be accepted for participants with metavir score f3. for cirrhotic participants (metavir score f4) a biopsy performed at any previous time is acceptable
Description

Fibrosis stage | Liver diseases Tumor Stage Classification | Transient elastography | Metavir score | Liver Cirrhosis | Biopsy

Data type

boolean

Alias
UMLS CUI [1]
C1954435
UMLS CUI [2,1]
C0023895
UMLS CUI [2,2]
C0178759
UMLS CUI [3]
C2748260
UMLS CUI [4]
C3888527
UMLS CUI [5]
C0023890
UMLS CUI [6]
C0005558
participants who have cirrhosis must have an hepatic imaging procedure (ultrasound, computed tomography [ct] scan or magnetic resonance imaging [mri]) within 6 months prior to the screening visit (or between screening and day 1) with no findings suspicious for hepatocellular carcinoma
Description

Liver Cirrhosis | Imaging of liver | Ultrasonics (sound) | X-Ray Computed Tomography | Magnetic Resonance Imaging | Liver carcinoma Absent

Data type

boolean

Alias
UMLS CUI [1]
C0023890
UMLS CUI [2]
C2711860
UMLS CUI [3]
C1456803
UMLS CUI [4]
C0040405
UMLS CUI [5]
C0024485
UMLS CUI [6,1]
C2239176
UMLS CUI [6,2]
C0332197
participant must have a body mass index (bmi) >= 18 kilogram per meter^2 (kg/m^2)
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
participant must be treatment naive (that is, have not received prior treatment for hcv with any approved or investigational drug)
Description

Therapy naive | Hepatitis C virus | Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0919936
UMLS CUI [2]
C0220847
UMLS CUI [3]
C0013230
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
participant has co-infection with hcv of another genotype; a) participant who has hcv genotype 1b has coinfection with hcv of a genotype other than genotype 1b
Description

HCV coinfection | Hepatitis C virus genotype

Data type

boolean

Alias
UMLS CUI [1]
C1698259
UMLS CUI [2]
C1148363
chronic hcv genotype 1b-infected participant who has the presence of genetic variants coding for the ns5a-y93h and/or l31m/v amino acid substitutions at screening
Description

Hepatitis C virus genotype 1b positive | Genetic variant assessment | Amino Acid Substitution

Data type

boolean

Alias
UMLS CUI [1]
C3495940
UMLS CUI [2]
C3263354
UMLS CUI [3]
C0525038
participant has evidence of current or previous episodes of hepatic decompensation (including controlled or uncontrolled ascites, bleeding varices or hepatic encephalopathy)
Description

hepatic; decompensation Episode | Ascites | Bleeding varices | Hepatic Encephalopathy

Data type

boolean

Alias
UMLS CUI [1,1]
C1394798
UMLS CUI [1,2]
C0332189
UMLS CUI [2]
C0003962
UMLS CUI [3]
C0333106
UMLS CUI [4]
C0019151
participant has chronic liver disease of a non-hcv etiology (including but not limited to hemochromatosis, wilson's disease, alfa 1-antitrypsin deficiency, cholangitis, drug- or alcohol-related liver disease, primary biliary cirrhosis)
Description

Chronic liver disease Etiology aspects Hepatitis C virus | Hemochromatosis | Hepatolenticular Degeneration | alpha 1-Antitrypsin Deficiency | Cholangitis | Liver diseases Due to Substance Use Disorders | Primary biliary cirrhosis

Data type

boolean

Alias
UMLS CUI [1,1]
C0341439
UMLS CUI [1,2]
C0015127
UMLS CUI [1,3]
C0220847
UMLS CUI [2]
C0018995
UMLS CUI [3]
C0019202
UMLS CUI [4]
C0221757
UMLS CUI [5]
C0008311
UMLS CUI [6,1]
C0023895
UMLS CUI [6,2]
C0678226
UMLS CUI [6,3]
C0038586
UMLS CUI [7]
C0008312
participant has any other uncontrolled clinically significant disease or clinically significant findings during screening that in the opinion of the investigator could compromise the participants' safety or could interfere with the participant participating in and completing the study
Description

Disease At risk patient safety | Disease Study Subject Participation Status Compliance behavior Limited

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1444641
UMLS CUI [1,3]
C1113679
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C2348568
UMLS CUI [2,3]
C1321605
UMLS CUI [2,4]
C0439801
participant has coinfection with hepatitis a or hepatitis b virus (hepatitis a antibody immunoglobulin m [igm] or hepatitis b surface antigen [hbsag] positive at screening)
Description

Coinfection Hepatitis A Virus | HBV coinfection | Hepatitis A virus IgM antibody Positive | Hepatitis B surface antigen positive

Data type

boolean

Alias
UMLS CUI [1,1]
C0275524
UMLS CUI [1,2]
C0376325
UMLS CUI [2]
C2242656
UMLS CUI [3,1]
C0369327
UMLS CUI [3,2]
C1446409
UMLS CUI [4]
C0149709
participant has received a solid organ transplant
Description

Solid organ transplant

Data type

boolean

Alias
UMLS CUI [1]
C0730400
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Similar models

Eligibility Hepatitis C, Chronic NCT02268864

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Chronic infectious disease Hepatitis C virus genotype 1b
Item
participant must have chronic hepatitis c virus (hcv) genotype 1b infection confirmed at screening
boolean
C0151317 (UMLS CUI [1,1])
C3495940 (UMLS CUI [1,2])
HCV viral load
Item
participant must have hcv ribonucleic acid (rna) greater than (>) 10,000 international unit per milliliter (iu/ml) at screening
boolean
C1868902 (UMLS CUI [1])
Fibrosis stage | Liver diseases Tumor Stage Classification | Transient elastography | Metavir score | Liver Cirrhosis | Biopsy
Item
participant must have documented fibrosis stage at screening (or between screening and day 1 [baseline]). liver disease will be staged based on one of the following methods. a) shear wave elastography (fibroscan) within less than or equal to (<=) 6 months before screening or between screening and day 1 (baseline). metavir f3 > 9.6 kilopascals (kpa) and the cut-off for cirrhosis is greater than or equal to (>=) 14.6 kpa. b) a biopsy documenting metavir f3-f4. biopsy performed within the 24 months before screening will be accepted for participants with metavir score f3. for cirrhotic participants (metavir score f4) a biopsy performed at any previous time is acceptable
boolean
C1954435 (UMLS CUI [1])
C0023895 (UMLS CUI [2,1])
C0178759 (UMLS CUI [2,2])
C2748260 (UMLS CUI [3])
C3888527 (UMLS CUI [4])
C0023890 (UMLS CUI [5])
C0005558 (UMLS CUI [6])
Liver Cirrhosis | Imaging of liver | Ultrasonics (sound) | X-Ray Computed Tomography | Magnetic Resonance Imaging | Liver carcinoma Absent
Item
participants who have cirrhosis must have an hepatic imaging procedure (ultrasound, computed tomography [ct] scan or magnetic resonance imaging [mri]) within 6 months prior to the screening visit (or between screening and day 1) with no findings suspicious for hepatocellular carcinoma
boolean
C0023890 (UMLS CUI [1])
C2711860 (UMLS CUI [2])
C1456803 (UMLS CUI [3])
C0040405 (UMLS CUI [4])
C0024485 (UMLS CUI [5])
C2239176 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
Body mass index
Item
participant must have a body mass index (bmi) >= 18 kilogram per meter^2 (kg/m^2)
boolean
C1305855 (UMLS CUI [1])
Therapy naive | Hepatitis C virus | Investigational New Drugs
Item
participant must be treatment naive (that is, have not received prior treatment for hcv with any approved or investigational drug)
boolean
C0919936 (UMLS CUI [1])
C0220847 (UMLS CUI [2])
C0013230 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
HCV coinfection | Hepatitis C virus genotype
Item
participant has co-infection with hcv of another genotype; a) participant who has hcv genotype 1b has coinfection with hcv of a genotype other than genotype 1b
boolean
C1698259 (UMLS CUI [1])
C1148363 (UMLS CUI [2])
Hepatitis C virus genotype 1b positive | Genetic variant assessment | Amino Acid Substitution
Item
chronic hcv genotype 1b-infected participant who has the presence of genetic variants coding for the ns5a-y93h and/or l31m/v amino acid substitutions at screening
boolean
C3495940 (UMLS CUI [1])
C3263354 (UMLS CUI [2])
C0525038 (UMLS CUI [3])
hepatic; decompensation Episode | Ascites | Bleeding varices | Hepatic Encephalopathy
Item
participant has evidence of current or previous episodes of hepatic decompensation (including controlled or uncontrolled ascites, bleeding varices or hepatic encephalopathy)
boolean
C1394798 (UMLS CUI [1,1])
C0332189 (UMLS CUI [1,2])
C0003962 (UMLS CUI [2])
C0333106 (UMLS CUI [3])
C0019151 (UMLS CUI [4])
Chronic liver disease Etiology aspects Hepatitis C virus | Hemochromatosis | Hepatolenticular Degeneration | alpha 1-Antitrypsin Deficiency | Cholangitis | Liver diseases Due to Substance Use Disorders | Primary biliary cirrhosis
Item
participant has chronic liver disease of a non-hcv etiology (including but not limited to hemochromatosis, wilson's disease, alfa 1-antitrypsin deficiency, cholangitis, drug- or alcohol-related liver disease, primary biliary cirrhosis)
boolean
C0341439 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
C0220847 (UMLS CUI [1,3])
C0018995 (UMLS CUI [2])
C0019202 (UMLS CUI [3])
C0221757 (UMLS CUI [4])
C0008311 (UMLS CUI [5])
C0023895 (UMLS CUI [6,1])
C0678226 (UMLS CUI [6,2])
C0038586 (UMLS CUI [6,3])
C0008312 (UMLS CUI [7])
Disease At risk patient safety | Disease Study Subject Participation Status Compliance behavior Limited
Item
participant has any other uncontrolled clinically significant disease or clinically significant findings during screening that in the opinion of the investigator could compromise the participants' safety or could interfere with the participant participating in and completing the study
boolean
C0012634 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
C0012634 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C1321605 (UMLS CUI [2,3])
C0439801 (UMLS CUI [2,4])
Coinfection Hepatitis A Virus | HBV coinfection | Hepatitis A virus IgM antibody Positive | Hepatitis B surface antigen positive
Item
participant has coinfection with hepatitis a or hepatitis b virus (hepatitis a antibody immunoglobulin m [igm] or hepatitis b surface antigen [hbsag] positive at screening)
boolean
C0275524 (UMLS CUI [1,1])
C0376325 (UMLS CUI [1,2])
C2242656 (UMLS CUI [2])
C0369327 (UMLS CUI [3,1])
C1446409 (UMLS CUI [3,2])
C0149709 (UMLS CUI [4])
Solid organ transplant
Item
participant has received a solid organ transplant
boolean
C0730400 (UMLS CUI [1])
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