ID

39676

Beskrivning

UNITY 2: A Study of an Investigational Treatment Regimen of DCV+ASV+BMS-791325 in a Fixed Dose Combination (the DCV 3DAA (Direct Acting Antiviral) Regimen) With or Without RBV for 12 Weeks for the Treatment of Chronic Hepatitis C Virus(HCV)Genotype 1 Infection in Subjects With Compensated Cirrhosis; ODM derived from: https://clinicaltrials.gov/show/NCT01973049

Länk

https://clinicaltrials.gov/show/NCT01973049

Nyckelord

Versioner (1)
  1. 2020-02-09 2020-02-09 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

9 februari 2020

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Eligibility Hepatitis C NCT01973049

Engelsk

Eligibility Hepatitis C NCT01973049

1 Formulär  
Criteria
Beskrivning

Criteria

Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects chronically infected with hcv genotype 1
Beskrivning

Chronic Hepatitis C Genotype

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0524910
UMLS CUI [1,2]
C1533728
subjects with compensated cirrhosis
Beskrivning

Compensated cirrhosis

Datatyp

boolean

Alias
UMLS CUI [1]
C1608426
hcv rna ≥ 10,000 iu/ml at screening
Beskrivning

Hepatitis C virus RNA assay

Datatyp

boolean

Alias
UMLS CUI [1]
C1272251
treatment-naïve subjects with no previous exposure to an interferon formulation (ie, ifnα, pegifnα), ribavirin (rbv), or hcv direct acting antivirals (daa) (protease, polymerase inhibitor, etc.)
Beskrivning

Study Subjects Therapy naive | Interferon Absent | Interferon-alpha Absent | Peginterferon alfa-2a Absent | Peginterferon alfa-2b Absent | Ribavirin Absent | HCV DIRECT ACTING ANTIVIRALS Absent | Protease Inhibitors Absent | RNA dependent RNA Polymerase Inhibitors Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0919936
UMLS CUI [2,1]
C3652465
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0002199
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0391001
UMLS CUI [4,2]
C0332197
UMLS CUI [5,1]
C0796545
UMLS CUI [5,2]
C0332197
UMLS CUI [6,1]
C0035525
UMLS CUI [6,2]
C0332197
UMLS CUI [7,1]
C0220847
UMLS CUI [7,2]
C3653501
UMLS CUI [7,3]
C0332197
UMLS CUI [8,1]
C0033607
UMLS CUI [8,2]
C0332197
UMLS CUI [9,1]
C3883351
UMLS CUI [9,2]
C0332197
treatment-experienced subjects are eligible including exposure to anti-hcv agents of a mechanistic class other than those contained in the daclatasvir (dcv) / asunaprevir (asv) /bms-791325 triple regimen is permitted. examples of permitted agents include, but are not limited to nucleoside/nucleotide inhibitors of nonstructural protein 5b (ns5b) polymerase, inhibitors of cyclophilin, or inhibitors of microrna.
Beskrivning

Study Subjects Therapy Experience | Anti-hepatitis C (HCV) Agents | Exception Daclatasvir | Exception Asunaprevir | Exception BMS-791325 | Nucleoside inhibitor | Nucleotide inhibitors | Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor | Cyclophilin inhibitors | MicroRNA inhibitors

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0596545
UMLS CUI [2]
C4324240
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C3252090
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C3491974
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C3852614
UMLS CUI [6]
C0597104
UMLS CUI [7,1]
C0028630
UMLS CUI [7,2]
C0243077
UMLS CUI [8]
C4020255
UMLS CUI [9,1]
C0917877
UMLS CUI [9,2]
C0243077
UMLS CUI [10,1]
C1101610
UMLS CUI [10,2]
C0243077
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects without cirrhosis
Beskrivning

Liver Cirrhosis Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0023890
UMLS CUI [1,2]
C0332197
liver or any other organ transplant
Beskrivning

Transplantation of liver | Organ Transplantation

Datatyp

boolean

Alias
UMLS CUI [1]
C0023911
UMLS CUI [2]
C0029216
current or known history of cancer within 5 years prior to screening
Beskrivning

Malignant Neoplasms

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
documented or suspected hepatocellular carcinoma(hcc)
Beskrivning

Liver carcinoma | Liver carcinoma Suspected

Datatyp

boolean

Alias
UMLS CUI [1]
C2239176
UMLS CUI [2,1]
C2239176
UMLS CUI [2,2]
C0750491
evidence of decompensated liver disease including, but not limited to, radiologic criteria, a history or presence of ascites, bleeding varices, or hepatic encephalopathy
Beskrivning

Decompensated liver disease Radiology | Ascites | Bleeding varices | Hepatic Encephalopathy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C4075847
UMLS CUI [1,2]
C0043299
UMLS CUI [2]
C0003962
UMLS CUI [3]
C0333106
UMLS CUI [4]
C0019151
Tillbaka till toppen

Similar models

Eligibility Hepatitis C NCT01973049

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Item Group
C1512693 (UMLS CUI)
Chronic Hepatitis C Genotype
Item
subjects chronically infected with hcv genotype 1
boolean
C0524910 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
Compensated cirrhosis
Item
subjects with compensated cirrhosis
boolean
C1608426 (UMLS CUI [1])
Hepatitis C virus RNA assay
Item
hcv rna ≥ 10,000 iu/ml at screening
boolean
C1272251 (UMLS CUI [1])
Study Subjects Therapy naive | Interferon Absent | Interferon-alpha Absent | Peginterferon alfa-2a Absent | Peginterferon alfa-2b Absent | Ribavirin Absent | HCV DIRECT ACTING ANTIVIRALS Absent | Protease Inhibitors Absent | RNA dependent RNA Polymerase Inhibitors Absent
Item
treatment-naïve subjects with no previous exposure to an interferon formulation (ie, ifnα, pegifnα), ribavirin (rbv), or hcv direct acting antivirals (daa) (protease, polymerase inhibitor, etc.)
boolean
C0681850 (UMLS CUI [1,1])
C0919936 (UMLS CUI [1,2])
C3652465 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0002199 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0391001 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0796545 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C0035525 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
C0220847 (UMLS CUI [7,1])
C3653501 (UMLS CUI [7,2])
C0332197 (UMLS CUI [7,3])
C0033607 (UMLS CUI [8,1])
C0332197 (UMLS CUI [8,2])
C3883351 (UMLS CUI [9,1])
C0332197 (UMLS CUI [9,2])
Study Subjects Therapy Experience | Anti-hepatitis C (HCV) Agents | Exception Daclatasvir | Exception Asunaprevir | Exception BMS-791325 | Nucleoside inhibitor | Nucleotide inhibitors | Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor | Cyclophilin inhibitors | MicroRNA inhibitors
Item
treatment-experienced subjects are eligible including exposure to anti-hcv agents of a mechanistic class other than those contained in the daclatasvir (dcv) / asunaprevir (asv) /bms-791325 triple regimen is permitted. examples of permitted agents include, but are not limited to nucleoside/nucleotide inhibitors of nonstructural protein 5b (ns5b) polymerase, inhibitors of cyclophilin, or inhibitors of microrna.
boolean
C0681850 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0596545 (UMLS CUI [1,3])
C4324240 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C3252090 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C3491974 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C3852614 (UMLS CUI [5,2])
C0597104 (UMLS CUI [6])
C0028630 (UMLS CUI [7,1])
C0243077 (UMLS CUI [7,2])
C4020255 (UMLS CUI [8])
C0917877 (UMLS CUI [9,1])
C0243077 (UMLS CUI [9,2])
C1101610 (UMLS CUI [10,1])
C0243077 (UMLS CUI [10,2])
Item Group
C0680251 (UMLS CUI)
Liver Cirrhosis Absent
Item
subjects without cirrhosis
boolean
C0023890 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Transplantation of liver | Organ Transplantation
Item
liver or any other organ transplant
boolean
C0023911 (UMLS CUI [1])
C0029216 (UMLS CUI [2])
Malignant Neoplasms
Item
current or known history of cancer within 5 years prior to screening
boolean
C0006826 (UMLS CUI [1])
Liver carcinoma | Liver carcinoma Suspected
Item
documented or suspected hepatocellular carcinoma(hcc)
boolean
C2239176 (UMLS CUI [1])
C2239176 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
Decompensated liver disease Radiology | Ascites | Bleeding varices | Hepatic Encephalopathy
Item
evidence of decompensated liver disease including, but not limited to, radiologic criteria, a history or presence of ascites, bleeding varices, or hepatic encephalopathy
boolean
C4075847 (UMLS CUI [1,1])
C0043299 (UMLS CUI [1,2])
C0003962 (UMLS CUI [2])
C0333106 (UMLS CUI [3])
C0019151 (UMLS CUI [4])
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

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