ID

39676

Description

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

Link

https://clinicaltrials.gov/show/NCT01973049

Keywords

Versions (1)
  1. 2/9/20 2/9/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 9, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatitis C NCT01973049

English

Eligibility Hepatitis C NCT01973049

1 forms  
Criteria
Description

Criteria

Inclusion Criteria
Description

Inclusion Criteria

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

Chronic Hepatitis C Genotype

Data type

boolean

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

Compensated cirrhosis

Data type

boolean

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

Hepatitis C virus RNA assay

Data type

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.)
Description

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

Data type

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.
Description

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

Data type

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
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects without cirrhosis
Description

Liver Cirrhosis Absent

Data type

boolean

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

Transplantation of liver | Organ Transplantation

Data type

boolean

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

Malignant Neoplasms

Data type

boolean

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

Liver carcinoma | Liver carcinoma Suspected

Data type

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
Description

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

Data type

boolean

Alias
UMLS CUI [1,1]
C4075847
UMLS CUI [1,2]
C0043299
UMLS CUI [2]
C0003962
UMLS CUI [3]
C0333106
UMLS CUI [4]
C0019151
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Similar models

Eligibility Hepatitis C NCT01973049

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
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