ID

15269

Description

Study to Assess Efficacy, Safety, Tolerability and Pharmacokinetics of Simeprevir, Daclatasvir and Sofosbuvir in Treatment-naive Participants With Chronic Hepatitis C Virus Genotype 1 Infection; ODM derived from: https://clinicaltrials.gov/show/NCT02349048

Link

https://clinicaltrials.gov/show/NCT02349048

Keywords

Versions (2)
  1. 5/24/16 5/24/16 -
  2. 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 Virus NCT02349048

English

Eligibility Hepatitis C Virus NCT02349048

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
hcv genotype 1 infection and hcv rna plasma level greater than (>) 10,000 international units per milliliter (iu/ml), both determined at screening
Description

Hepatitis C virus genotype 1 Communicable Disease | HCV viral load Plasma Level

Data type

boolean

Alias
UMLS CUI [1,1]
C3532919
UMLS CUI [1,2]
C0009450
UMLS CUI [2,1]
C1868902
UMLS CUI [2,2]
C0032105
UMLS CUI [2,3]
C0441889
participants of arm a should have evidence of early stages of liver fibrosis, defined by a fibrosure score less than or equal to (<=) 0.48 and aspartate aminotransferase to platelet ratio index (apri) score <=1
Description

Protocol Treatment Arm | Fibrosis, Liver Early stage | FibroTest Score Measurement | Aspartate aminotransferase measurement Platelet Count measurement Ratio Index

Data type

boolean

Alias
UMLS CUI [1]
C1522541
UMLS CUI [2,1]
C0239946
UMLS CUI [2,2]
C2363430
UMLS CUI [3]
C3642160
UMLS CUI [4,1]
C0201899
UMLS CUI [4,2]
C0032181
UMLS CUI [4,3]
C0456603
UMLS CUI [4,4]
C0918012
participants of arm b should have evidence of cirrhosis, defined by a fibrosure score >0.75 and apri score >2, or a previous (historical) biopsy documenting a metavir score f4. in addition, participants should have absence of esophageal varices or presence of small (grade 1) esophageal varices determined by upper gastrointestinal endoscopy, and absence of findings indicative of hepatocellular carcinoma in an ultrasonography
Description

Protocol Treatment Arm | Liver Cirrhosis | FibroTest Score Measurement | Aspartate aminotransferase measurement Platelet Count measurement Ratio Index | Biopsy Previous | Metavir score | Esophageal Varices Absent | Grade I esophageal varices | Esophagogastroduodenoscopy | Liver carcinoma Absent | Ultrasonography

Data type

boolean

Alias
UMLS CUI [1]
C1522541
UMLS CUI [2]
C0023890
UMLS CUI [3]
C3642160
UMLS CUI [4,1]
C0201899
UMLS CUI [4,2]
C0032181
UMLS CUI [4,3]
C0456603
UMLS CUI [4,4]
C0918012
UMLS CUI [5,1]
C0005558
UMLS CUI [5,2]
C0205156
UMLS CUI [6]
C3888527
UMLS CUI [7,1]
C0014867
UMLS CUI [7,2]
C0332197
UMLS CUI [8]
C0940116
UMLS CUI [9]
C0079304
UMLS CUI [10,1]
C2239176
UMLS CUI [10,2]
C0332197
UMLS CUI [11]
C0041618
hcv treatment-naive, defined as not having received treatment with any approved or investigational drug for chronic hcv infection
Description

Therapy naive Hepatitis C virus | Therapeutic procedure Investigational New Drugs Hepatitis C, Chronic

Data type

boolean

Alias
UMLS CUI [1,1]
C0919936
UMLS CUI [1,2]
C0220847
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0013230
UMLS CUI [2,3]
C0524910
pegylated interferon (pegifn) and ribavirin (rbv) eligible, defined as not having any contraindication to the use of pegifn and rbv, in line with the prescribing information for each compound
Description

pegylated interferon alfa | Ribavirin | Medical contraindication pegylated interferon alfa Ribavirin

Data type

boolean

Alias
UMLS CUI [1]
C0907160
UMLS CUI [2]
C0035525
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C0907160
UMLS CUI [3,3]
C0035525
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
a. main study:
Description

Study Main

Data type

boolean

Alias
UMLS CUI [1,1]
C2603343
UMLS CUI [1,2]
C1542147
co-infection with hcv of another genotype than genotype 1 and/or human immunodeficiency virus (hiv) type 1 or 2 (positive hiv-1 or hiv 2 antibody test at screening)
Description

HCV coinfection | Hepatitis C virus genotype | Coinfection HIV-1 | Coinfection Human immunodeficiency virus 2 (HIV-2) | HIV-1 Antibody Measurement Positive | HIV-2 Antibody Measurement Positive

Data type

boolean

Alias
UMLS CUI [1]
C1698259
UMLS CUI [2]
C1148363
UMLS CUI [3,1]
C0275524
UMLS CUI [3,2]
C0019704
UMLS CUI [4,1]
C0275524
UMLS CUI [4,2]
C0019707
UMLS CUI [5,1]
C0373916
UMLS CUI [5,2]
C1446409
UMLS CUI [6,1]
C0373917
UMLS CUI [6,2]
C1446409
any evidence of liver disease of non-hcv etiology. this includes, but is not limited to, acute hepatitis a infection, hepatitis b infection (hepatitis b surface antigen positive), drug- or alcohol-related liver disease, autoimmune hepatitis, hemochromatosis, wilson's disease, alpha-1 antitrypsin deficiency, non-alcoholic steatohepatitis, primary biliary cirrhosis, or any other non-hcv liver disease considered clinically significant by the investigator
Description

Liver diseases Etiology aspects Hepatitis C virus | Hepatitis A - current infection | Hepatitis B | Hepatitis B surface antigen positive | Liver diseases Due to Substance Use Disorders | Hepatitis, Autoimmune | Hemochromatosis | Hepatolenticular Degeneration | alpha 1-Antitrypsin Deficiency | Nonalcoholic Steatohepatitis | Primary biliary cirrhosis

Data type

boolean

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0015127
UMLS CUI [1,3]
C0220847
UMLS CUI [2]
C0588457
UMLS CUI [3]
C0019163
UMLS CUI [4]
C0149709
UMLS CUI [5,1]
C0023895
UMLS CUI [5,2]
C0678226
UMLS CUI [5,3]
C0038586
UMLS CUI [6]
C0241910
UMLS CUI [7]
C0018995
UMLS CUI [8]
C0019202
UMLS CUI [9]
C0221757
UMLS CUI [10]
C3241937
UMLS CUI [11]
C0008312
evidence of clinical hepatic decompensation or presence of grade 2/3 esophageal varices
Description

hepatic; decompensation | grade of esophageal varices

Data type

boolean

Alias
UMLS CUI [1]
C1394798
UMLS CUI [2]
C0940115
any of the protocol defined laboratory abnormalities
Description

LABORATORY ABNORMALITIES

Data type

boolean

Alias
UMLS CUI [1]
C1853129
b. sub-study:
Description

Study Subtype

Data type

boolean

Alias
UMLS CUI [1,1]
C2603343
UMLS CUI [1,2]
C0449560
presence of coagulopathy (hemophilia) or hemoglobinopathy (including sickle cell disease, thalassemia)
Description

Blood Coagulation Disorders | Hemophilia | Hemoglobinopathies | Anemia, Sickle Cell | Thalassemia

Data type

boolean

Alias
UMLS CUI [1]
C0005779
UMLS CUI [2]
C0684275
UMLS CUI [3]
C0019045
UMLS CUI [4]
C0002895
UMLS CUI [5]
C0039730
use of any anti-coagulant (for example, warfarin, heparin) or anti-platelet medications within 1 week of the screening visit
Description

Anticoagulants | Warfarin | Heparin | Antiplatelet Agents

Data type

boolean

Alias
UMLS CUI [1]
C0003280
UMLS CUI [2]
C0043031
UMLS CUI [3]
C0019134
UMLS CUI [4]
C0085826
any of the protocol defined laboratory abnormalities
Description

LABORATORY ABNORMALITIES

Data type

boolean

Alias
UMLS CUI [1]
C1853129
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Similar models

Eligibility Hepatitis C Virus NCT02349048

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Hepatitis C virus genotype 1 Communicable Disease | HCV viral load Plasma Level
Item
hcv genotype 1 infection and hcv rna plasma level greater than (>) 10,000 international units per milliliter (iu/ml), both determined at screening
boolean
C3532919 (UMLS CUI [1,1])
C0009450 (UMLS CUI [1,2])
C1868902 (UMLS CUI [2,1])
C0032105 (UMLS CUI [2,2])
C0441889 (UMLS CUI [2,3])
Protocol Treatment Arm | Fibrosis, Liver Early stage | FibroTest Score Measurement | Aspartate aminotransferase measurement Platelet Count measurement Ratio Index
Item
participants of arm a should have evidence of early stages of liver fibrosis, defined by a fibrosure score less than or equal to (<=) 0.48 and aspartate aminotransferase to platelet ratio index (apri) score <=1
boolean
C1522541 (UMLS CUI [1])
C0239946 (UMLS CUI [2,1])
C2363430 (UMLS CUI [2,2])
C3642160 (UMLS CUI [3])
C0201899 (UMLS CUI [4,1])
C0032181 (UMLS CUI [4,2])
C0456603 (UMLS CUI [4,3])
C0918012 (UMLS CUI [4,4])
Protocol Treatment Arm | Liver Cirrhosis | FibroTest Score Measurement | Aspartate aminotransferase measurement Platelet Count measurement Ratio Index | Biopsy Previous | Metavir score | Esophageal Varices Absent | Grade I esophageal varices | Esophagogastroduodenoscopy | Liver carcinoma Absent | Ultrasonography
Item
participants of arm b should have evidence of cirrhosis, defined by a fibrosure score >0.75 and apri score >2, or a previous (historical) biopsy documenting a metavir score f4. in addition, participants should have absence of esophageal varices or presence of small (grade 1) esophageal varices determined by upper gastrointestinal endoscopy, and absence of findings indicative of hepatocellular carcinoma in an ultrasonography
boolean
C1522541 (UMLS CUI [1])
C0023890 (UMLS CUI [2])
C3642160 (UMLS CUI [3])
C0201899 (UMLS CUI [4,1])
C0032181 (UMLS CUI [4,2])
C0456603 (UMLS CUI [4,3])
C0918012 (UMLS CUI [4,4])
C0005558 (UMLS CUI [5,1])
C0205156 (UMLS CUI [5,2])
C3888527 (UMLS CUI [6])
C0014867 (UMLS CUI [7,1])
C0332197 (UMLS CUI [7,2])
C0940116 (UMLS CUI [8])
C0079304 (UMLS CUI [9])
C2239176 (UMLS CUI [10,1])
C0332197 (UMLS CUI [10,2])
C0041618 (UMLS CUI [11])
Therapy naive Hepatitis C virus | Therapeutic procedure Investigational New Drugs Hepatitis C, Chronic
Item
hcv treatment-naive, defined as not having received treatment with any approved or investigational drug for chronic hcv infection
boolean
C0919936 (UMLS CUI [1,1])
C0220847 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C0524910 (UMLS CUI [2,3])
pegylated interferon alfa | Ribavirin | Medical contraindication pegylated interferon alfa Ribavirin
Item
pegylated interferon (pegifn) and ribavirin (rbv) eligible, defined as not having any contraindication to the use of pegifn and rbv, in line with the prescribing information for each compound
boolean
C0907160 (UMLS CUI [1])
C0035525 (UMLS CUI [2])
C1301624 (UMLS CUI [3,1])
C0907160 (UMLS CUI [3,2])
C0035525 (UMLS CUI [3,3])
Item Group
C0680251 (UMLS CUI)
Study Main
Item
a. main study:
boolean
C2603343 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
HCV coinfection | Hepatitis C virus genotype | Coinfection HIV-1 | Coinfection Human immunodeficiency virus 2 (HIV-2) | HIV-1 Antibody Measurement Positive | HIV-2 Antibody Measurement Positive
Item
co-infection with hcv of another genotype than genotype 1 and/or human immunodeficiency virus (hiv) type 1 or 2 (positive hiv-1 or hiv 2 antibody test at screening)
boolean
C1698259 (UMLS CUI [1])
C1148363 (UMLS CUI [2])
C0275524 (UMLS CUI [3,1])
C0019704 (UMLS CUI [3,2])
C0275524 (UMLS CUI [4,1])
C0019707 (UMLS CUI [4,2])
C0373916 (UMLS CUI [5,1])
C1446409 (UMLS CUI [5,2])
C0373917 (UMLS CUI [6,1])
C1446409 (UMLS CUI [6,2])
Liver diseases Etiology aspects Hepatitis C virus | Hepatitis A - current infection | Hepatitis B | Hepatitis B surface antigen positive | Liver diseases Due to Substance Use Disorders | Hepatitis, Autoimmune | Hemochromatosis | Hepatolenticular Degeneration | alpha 1-Antitrypsin Deficiency | Nonalcoholic Steatohepatitis | Primary biliary cirrhosis
Item
any evidence of liver disease of non-hcv etiology. this includes, but is not limited to, acute hepatitis a infection, hepatitis b infection (hepatitis b surface antigen positive), drug- or alcohol-related liver disease, autoimmune hepatitis, hemochromatosis, wilson's disease, alpha-1 antitrypsin deficiency, non-alcoholic steatohepatitis, primary biliary cirrhosis, or any other non-hcv liver disease considered clinically significant by the investigator
boolean
C0023895 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
C0220847 (UMLS CUI [1,3])
C0588457 (UMLS CUI [2])
C0019163 (UMLS CUI [3])
C0149709 (UMLS CUI [4])
C0023895 (UMLS CUI [5,1])
C0678226 (UMLS CUI [5,2])
C0038586 (UMLS CUI [5,3])
C0241910 (UMLS CUI [6])
C0018995 (UMLS CUI [7])
C0019202 (UMLS CUI [8])
C0221757 (UMLS CUI [9])
C3241937 (UMLS CUI [10])
C0008312 (UMLS CUI [11])
hepatic; decompensation | grade of esophageal varices
Item
evidence of clinical hepatic decompensation or presence of grade 2/3 esophageal varices
boolean
C1394798 (UMLS CUI [1])
C0940115 (UMLS CUI [2])
LABORATORY ABNORMALITIES
Item
any of the protocol defined laboratory abnormalities
boolean
C1853129 (UMLS CUI [1])
Study Subtype
Item
b. sub-study:
boolean
C2603343 (UMLS CUI [1,1])
C0449560 (UMLS CUI [1,2])
Blood Coagulation Disorders | Hemophilia | Hemoglobinopathies | Anemia, Sickle Cell | Thalassemia
Item
presence of coagulopathy (hemophilia) or hemoglobinopathy (including sickle cell disease, thalassemia)
boolean
C0005779 (UMLS CUI [1])
C0684275 (UMLS CUI [2])
C0019045 (UMLS CUI [3])
C0002895 (UMLS CUI [4])
C0039730 (UMLS CUI [5])
Anticoagulants | Warfarin | Heparin | Antiplatelet Agents
Item
use of any anti-coagulant (for example, warfarin, heparin) or anti-platelet medications within 1 week of the screening visit
boolean
C0003280 (UMLS CUI [1])
C0043031 (UMLS CUI [2])
C0019134 (UMLS CUI [3])
C0085826 (UMLS CUI [4])
LABORATORY ABNORMALITIES
Item
any of the protocol defined laboratory abnormalities
boolean
C1853129 (UMLS CUI [1])
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