ID

36060

Beschreibung

An Efficacy, Safety and Pharmacokinetics Study of Simeprevir, Daclatasvir and Sofosbuvir in Participants With Chronic Hepatitis C Virus Genotype 1 or 4 Infection and Decompensated Liver Disease; ODM derived from: https://clinicaltrials.gov/show/NCT02262728

Link

https://clinicaltrials.gov/show/NCT02262728

Stichworte

Versionen (2)
  1. 12.04.19 12.04.19 -
  2. 20.09.21 20.09.21 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

12. April 2019

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Hepatitis C, Chronic NCT02262728

Englisch

Eligibility Hepatitis C, Chronic NCT02262728

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
documented chronic hepatitis c virus (hcv) infection: diagnosis of hcv more than (>) 6 months before the screening visit, either by detectable hcv ribonucleic acid (rna), a hcv positive antibody or the presence of histological changes consistent with chronic hepatitis
Beschreibung

Chronic Hepatitis C Disease length | Hepatitis C virus RNA Detectable | Hepatitis C antibody positive | Change Histological Consistent with Chronic Hepatitis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0524910
UMLS CUI [1,2]
C0872146
UMLS CUI [2,1]
C0369335
UMLS CUI [2,2]
C3830527
UMLS CUI [3]
C0281863
UMLS CUI [4,1]
C0392747
UMLS CUI [4,2]
C0205462
UMLS CUI [4,3]
C0332290
UMLS CUI [4,4]
C0019189
hcv genotype 1 or 4 infection and hcv rna plasma level >10,000 international unit per milliliter (iu/ml)
Beschreibung

Hepatitis C Genotype determination | Hepatitis C virus RNA assay

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0019196
UMLS CUI [1,2]
C1533728
UMLS CUI [2]
C1272251
presence of cirrhosis, which is defined as a fibroscan with a result of >14.5 kilopascals (kpa) at screening
Beschreibung

Liver Cirrhosis | Fibroscan

Datentyp

boolean

Alias
UMLS CUI [1]
C0023890
UMLS CUI [2]
C4522043
hcv treatment-naive participants: participant has not received treatment with any approved or investigational drug for the treatment of hcv infection and hcv treatment-experienced participants: participant has had at least 1 documented previous course of a non-direct-acting antiviral agent (daa), interferon (ifn)-based hcv therapy (with or without ribavirin [rbv]). last dose in this previous course should have occurred at least 2 months prior to screening
Beschreibung

Therapy naive | Hepatitis C Untreated | Therapeutic procedure Experience Hepatitis C | DIRECT ACTING ANTIVIRALS Absent | Interferon | Ribavirin | Ribavirin Absent

Datentyp

boolean

Alias
UMLS CUI [1]
C0919936
UMLS CUI [2,1]
C0019196
UMLS CUI [2,2]
C0332155
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C0596545
UMLS CUI [3,3]
C0019196
UMLS CUI [4,1]
C3653501
UMLS CUI [4,2]
C0332197
UMLS CUI [5]
C3652465
UMLS CUI [6]
C0035525
UMLS CUI [7,1]
C0035525
UMLS CUI [7,2]
C0332197
decompensated liver disease: panel 1: child pugh a (mild hepatic impairment) with evidence of portal hypertension [confirmed by the presence of esophageal varices on gastroscopy or hepatic venous pressure gradient (hvpg) greater than or equal to (>=) 10 millimeter of mercury (mm hg)], panel 2: child-pugh b (moderate hepatic impairment)
Beschreibung

Decompensated liver disease | Child-Pugh Classification | Hepatic impairment Mild | Hypertension, Portal | Esophageal Varices Endoscopy of stomach | Hepatic venous pressure gradient | Child-Pugh Classification | Hepatic impairment Moderate

Datentyp

boolean

Alias
UMLS CUI [1]
C4075847
UMLS CUI [2]
C2347612
UMLS CUI [3,1]
C0948807
UMLS CUI [3,2]
C2945599
UMLS CUI [4]
C0020541
UMLS CUI [5,1]
C0014867
UMLS CUI [5,2]
C0017195
UMLS CUI [6]
C4049263
UMLS CUI [7]
C2347612
UMLS CUI [8,1]
C0948807
UMLS CUI [8,2]
C0205081
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
co-infection with any hcv genotype
Beschreibung

HCV coinfection Genotype

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1698259
UMLS CUI [1,2]
C1533728
co-infection with human immunodeficiency virus (hiv)-1 or -2 (positive hiv-1 or hiv-2 antibodies test at screening)
Beschreibung

Coinfection HIV-1 | Coinfection HIV-2 | Serum HIV-1 antibody test Positive | Serum antibody hiv-2 Positive

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0275524
UMLS CUI [1,2]
C0019704
UMLS CUI [2,1]
C0275524
UMLS CUI [2,2]
C0019707
UMLS CUI [3,1]
C2208696
UMLS CUI [3,2]
C1514241
UMLS CUI [4,1]
C3469372
UMLS CUI [4,2]
C1514241
co-infection with hepatitis b virus (hepatitis b surface antigen [hbsag] positive)
Beschreibung

HBV coinfection | Hepatitis B surface antigen positive

Datentyp

boolean

Alias
UMLS CUI [1]
C2242656
UMLS CUI [2]
C0149709
any evidence of liver disease of non-hcv etiology. this includes, but is not limited to, acute hepatitis a infection, 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
Beschreibung

Liver diseases | Etiology Absent Hepatitis C virus | Hepatitis A | Drug-Induced Liver Disease | Alcoholic Liver Diseases | Hepatitis, Autoimmune | Hemochromatosis | Hepatolenticular Degeneration | alpha 1-Antitrypsin Deficiency | Nonalcoholic Steatohepatitis | Primary biliary cirrhosis

Datentyp

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0220847
UMLS CUI [3]
C0019159
UMLS CUI [4]
C0860207
UMLS CUI [5]
C0023896
UMLS CUI [6]
C0241910
UMLS CUI [7]
C0018995
UMLS CUI [8]
C0019202
UMLS CUI [9]
C0221757
UMLS CUI [10]
C3241937
UMLS CUI [11]
C0008312
use of any disallowed therapies before the planned first dose of study drugs
Beschreibung

Therapy Illicit

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0332266
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Eligibility Hepatitis C, Chronic NCT02262728

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Chronic Hepatitis C Disease length | Hepatitis C virus RNA Detectable | Hepatitis C antibody positive | Change Histological Consistent with Chronic Hepatitis
Item
documented chronic hepatitis c virus (hcv) infection: diagnosis of hcv more than (>) 6 months before the screening visit, either by detectable hcv ribonucleic acid (rna), a hcv positive antibody or the presence of histological changes consistent with chronic hepatitis
boolean
C0524910 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C0369335 (UMLS CUI [2,1])
C3830527 (UMLS CUI [2,2])
C0281863 (UMLS CUI [3])
C0392747 (UMLS CUI [4,1])
C0205462 (UMLS CUI [4,2])
C0332290 (UMLS CUI [4,3])
C0019189 (UMLS CUI [4,4])
Hepatitis C Genotype determination | Hepatitis C virus RNA assay
Item
hcv genotype 1 or 4 infection and hcv rna plasma level >10,000 international unit per milliliter (iu/ml)
boolean
C0019196 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
C1272251 (UMLS CUI [2])
Liver Cirrhosis | Fibroscan
Item
presence of cirrhosis, which is defined as a fibroscan with a result of >14.5 kilopascals (kpa) at screening
boolean
C0023890 (UMLS CUI [1])
C4522043 (UMLS CUI [2])
Therapy naive | Hepatitis C Untreated | Therapeutic procedure Experience Hepatitis C | DIRECT ACTING ANTIVIRALS Absent | Interferon | Ribavirin | Ribavirin Absent
Item
hcv treatment-naive participants: participant has not received treatment with any approved or investigational drug for the treatment of hcv infection and hcv treatment-experienced participants: participant has had at least 1 documented previous course of a non-direct-acting antiviral agent (daa), interferon (ifn)-based hcv therapy (with or without ribavirin [rbv]). last dose in this previous course should have occurred at least 2 months prior to screening
boolean
C0919936 (UMLS CUI [1])
C0019196 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
C0087111 (UMLS CUI [3,1])
C0596545 (UMLS CUI [3,2])
C0019196 (UMLS CUI [3,3])
C3653501 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C3652465 (UMLS CUI [5])
C0035525 (UMLS CUI [6])
C0035525 (UMLS CUI [7,1])
C0332197 (UMLS CUI [7,2])
Decompensated liver disease | Child-Pugh Classification | Hepatic impairment Mild | Hypertension, Portal | Esophageal Varices Endoscopy of stomach | Hepatic venous pressure gradient | Child-Pugh Classification | Hepatic impairment Moderate
Item
decompensated liver disease: panel 1: child pugh a (mild hepatic impairment) with evidence of portal hypertension [confirmed by the presence of esophageal varices on gastroscopy or hepatic venous pressure gradient (hvpg) greater than or equal to (>=) 10 millimeter of mercury (mm hg)], panel 2: child-pugh b (moderate hepatic impairment)
boolean
C4075847 (UMLS CUI [1])
C2347612 (UMLS CUI [2])
C0948807 (UMLS CUI [3,1])
C2945599 (UMLS CUI [3,2])
C0020541 (UMLS CUI [4])
C0014867 (UMLS CUI [5,1])
C0017195 (UMLS CUI [5,2])
C4049263 (UMLS CUI [6])
C2347612 (UMLS CUI [7])
C0948807 (UMLS CUI [8,1])
C0205081 (UMLS CUI [8,2])
Item Group
C0680251 (UMLS CUI)
HCV coinfection Genotype
Item
co-infection with any hcv genotype
boolean
C1698259 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
Coinfection HIV-1 | Coinfection HIV-2 | Serum HIV-1 antibody test Positive | Serum antibody hiv-2 Positive
Item
co-infection with human immunodeficiency virus (hiv)-1 or -2 (positive hiv-1 or hiv-2 antibodies test at screening)
boolean
C0275524 (UMLS CUI [1,1])
C0019704 (UMLS CUI [1,2])
C0275524 (UMLS CUI [2,1])
C0019707 (UMLS CUI [2,2])
C2208696 (UMLS CUI [3,1])
C1514241 (UMLS CUI [3,2])
C3469372 (UMLS CUI [4,1])
C1514241 (UMLS CUI [4,2])
HBV coinfection | Hepatitis B surface antigen positive
Item
co-infection with hepatitis b virus (hepatitis b surface antigen [hbsag] positive)
boolean
C2242656 (UMLS CUI [1])
C0149709 (UMLS CUI [2])
Liver diseases | Etiology Absent Hepatitis C virus | Hepatitis A | Drug-Induced Liver Disease | Alcoholic Liver Diseases | 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, 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])
C0015127 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0220847 (UMLS CUI [2,3])
C0019159 (UMLS CUI [3])
C0860207 (UMLS CUI [4])
C0023896 (UMLS CUI [5])
C0241910 (UMLS CUI [6])
C0018995 (UMLS CUI [7])
C0019202 (UMLS CUI [8])
C0221757 (UMLS CUI [9])
C3241937 (UMLS CUI [10])
C0008312 (UMLS CUI [11])
Therapy Illicit
Item
use of any disallowed therapies before the planned first dose of study drugs
boolean
C0087111 (UMLS CUI [1,1])
C0332266 (UMLS CUI [1,2])
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