ID

44602

Description

A Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Ombitasvir/ABT-450/Ritonavir Co-administered With Ribavirin (RBV) in Adults With Genotype 4 Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis (AGATE-1); ODM derived from: https://clinicaltrials.gov/show/NCT02265237

Lien

https://clinicaltrials.gov/show/NCT02265237

Mots-clés

Versions (2)
  1. 03/06/2020 03/06/2020 -
  2. 27/09/2021 27/09/2021 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

27 septembre 2021

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
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Eligibility Hepatitis C Virus NCT02265237

Anglais

Eligibility Hepatitis C Virus NCT02265237

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects must meet one of the following:
Description

Inclusion criteria Quantity Fulfill

Type de données

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C1550543
treatment-naive (subject has never received antiviral treatment for hepatitis c infection) or for arms a, b, and c:
Description

Therapy naive | Antiviral Therapy Absent Hepatitis C | Protocol Arm Roman letter

Type de données

boolean

Alias
UMLS CUI [1]
C0919936
UMLS CUI [2,1]
C0280274
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0019196
UMLS CUI [3,1]
C1522541
UMLS CUI [3,2]
C0439102
treatment experienced (prior null responders, partial responders or relapsers to ifn/rbv)
Description

Therapy Received | Interferon | Ribavirin | Therapy non-responder | Partial responder to therapy | Relapse

Type de données

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C1514756
UMLS CUI [2]
C3652465
UMLS CUI [3]
C0035525
UMLS CUI [4]
C0919875
UMLS CUI [5]
C1740822
UMLS CUI [6]
C0035020
for arm d:
Description

Protocol Arm Roman letter

Type de données

boolean

Alias
UMLS CUI [1,1]
C1522541
UMLS CUI [1,2]
C0439102
treatment experienced (prior sofosbuvir (sof) breakthrough/non-responder or prior sof relapser to sof/pegifn/rbv or sof/rbv)
Description

Therapy Received | sofosbuvir | PEGINTERFERON | Ribavirin | Breakthrough | Therapy non-responder | Relapse

Type de données

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C1514756
UMLS CUI [2]
C2976303
UMLS CUI [3]
C0982327
UMLS CUI [4]
C0035525
UMLS CUI [5]
C3666010
UMLS CUI [6]
C0919875
UMLS CUI [7]
C0035020
subject has plasma hcv rna > 1000 iu/ml at screening
Description

Plasma Hepatitis C virus RNA assay

Type de données

boolean

Alias
UMLS CUI [1,1]
C0032105
UMLS CUI [1,2]
C1272251
chronic hcv genotype 4 infection with cirrhosis
Description

Chronic Hepatitis C Genotype | Liver Cirrhosis

Type de données

boolean

Alias
UMLS CUI [1,1]
C0524910
UMLS CUI [1,2]
C1533728
UMLS CUI [2]
C0023890
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
positive test result at screening for hepatitis b surface antigen (hbsag) or anti-human immunodeficiency virus antibody (hiv ab).
Description

Hepatitis B surface antigen positive | HIV antibody positive

Type de données

boolean

Alias
UMLS CUI [1]
C0149709
UMLS CUI [2]
C0920548
current enrollment in another interventional clinical study, previous enrollment in this study, or previous use of any protease inhibitor, non-nucleoside polymerase inhibitor, or nonstructural viral protein (ns) 5a inhibitor, either investigational or commercially available (including previous exposure to abt-450 or ombitasvir), or receipt of any investigational product within 6 weeks prior to study drug administration. prior use of any direct-acting antiviral will not be allowed, except for arm d where prior experience with the nucleoside polymerase inhibitor, sofosbuvir with pegifn/rbv or sof with rbv is required.
Description

Study Subject Participation Status | Interventional Study | Protease Inhibitors | Other Coding | Hepatitis C Virus NS5A Inhibitor | Exposure to ABT-450 | Exposure to Ombitasvir | Investigational New Drugs | DIRECT ACTING ANTIVIRALS

Type de données

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C3274035
UMLS CUI [3]
C0033607
UMLS CUI [4]
C3846158
UMLS CUI [5]
C3883357
UMLS CUI [6,1]
C0332157
UMLS CUI [6,2]
C3712108
UMLS CUI [7,1]
C0332157
UMLS CUI [7,2]
C3852670
UMLS CUI [8]
C0013230
UMLS CUI [9]
C3653501
any current or past clinical evidence of child-pugh b or c classification or clinical history of liver decompensation including ascites, variceal bleeding, or hepatic encephalopathy.
Description

Child-Pugh Classification | Hepatic decompensation | Ascites | Bleeding varices | Hepatic Encephalopathy

Type de données

boolean

Alias
UMLS CUI [1]
C4050412
UMLS CUI [2]
C1394798
UMLS CUI [3]
C0003962
UMLS CUI [4]
C0333106
UMLS CUI [5]
C0019151
confirmed presence of hepatocellular carcinoma.
Description

Liver carcinoma

Type de données

boolean

Alias
UMLS CUI [1]
C2239176
any cause of liver disease other than chronic hcv infection.
Description

Liver disease | Cause Except Chronic Hepatitis C

Type de données

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0332300
UMLS CUI [2,3]
C0524910
abnormal laboratory tests.
Description

Laboratory test result abnormal

Type de données

boolean

Alias
UMLS CUI [1]
C0438215
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Similar models

Eligibility Hepatitis C Virus NCT02265237

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Inclusion criteria Quantity Fulfill
Item
subjects must meet one of the following:
boolean
C1512693 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
Therapy naive | Antiviral Therapy Absent Hepatitis C | Protocol Arm Roman letter
Item
treatment-naive (subject has never received antiviral treatment for hepatitis c infection) or for arms a, b, and c:
boolean
C0919936 (UMLS CUI [1])
C0280274 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0019196 (UMLS CUI [2,3])
C1522541 (UMLS CUI [3,1])
C0439102 (UMLS CUI [3,2])
Therapy Received | Interferon | Ribavirin | Therapy non-responder | Partial responder to therapy | Relapse
Item
treatment experienced (prior null responders, partial responders or relapsers to ifn/rbv)
boolean
C0087111 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C3652465 (UMLS CUI [2])
C0035525 (UMLS CUI [3])
C0919875 (UMLS CUI [4])
C1740822 (UMLS CUI [5])
C0035020 (UMLS CUI [6])
Protocol Arm Roman letter
Item
for arm d:
boolean
C1522541 (UMLS CUI [1,1])
C0439102 (UMLS CUI [1,2])
Therapy Received | sofosbuvir | PEGINTERFERON | Ribavirin | Breakthrough | Therapy non-responder | Relapse
Item
treatment experienced (prior sofosbuvir (sof) breakthrough/non-responder or prior sof relapser to sof/pegifn/rbv or sof/rbv)
boolean
C0087111 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C2976303 (UMLS CUI [2])
C0982327 (UMLS CUI [3])
C0035525 (UMLS CUI [4])
C3666010 (UMLS CUI [5])
C0919875 (UMLS CUI [6])
C0035020 (UMLS CUI [7])
Plasma Hepatitis C virus RNA assay
Item
subject has plasma hcv rna > 1000 iu/ml at screening
boolean
C0032105 (UMLS CUI [1,1])
C1272251 (UMLS CUI [1,2])
Chronic Hepatitis C Genotype | Liver Cirrhosis
Item
chronic hcv genotype 4 infection with cirrhosis
boolean
C0524910 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
C0023890 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Hepatitis B surface antigen positive | HIV antibody positive
Item
positive test result at screening for hepatitis b surface antigen (hbsag) or anti-human immunodeficiency virus antibody (hiv ab).
boolean
C0149709 (UMLS CUI [1])
C0920548 (UMLS CUI [2])
Study Subject Participation Status | Interventional Study | Protease Inhibitors | Other Coding | Hepatitis C Virus NS5A Inhibitor | Exposure to ABT-450 | Exposure to Ombitasvir | Investigational New Drugs | DIRECT ACTING ANTIVIRALS
Item
current enrollment in another interventional clinical study, previous enrollment in this study, or previous use of any protease inhibitor, non-nucleoside polymerase inhibitor, or nonstructural viral protein (ns) 5a inhibitor, either investigational or commercially available (including previous exposure to abt-450 or ombitasvir), or receipt of any investigational product within 6 weeks prior to study drug administration. prior use of any direct-acting antiviral will not be allowed, except for arm d where prior experience with the nucleoside polymerase inhibitor, sofosbuvir with pegifn/rbv or sof with rbv is required.
boolean
C2348568 (UMLS CUI [1])
C3274035 (UMLS CUI [2])
C0033607 (UMLS CUI [3])
C3846158 (UMLS CUI [4])
C3883357 (UMLS CUI [5])
C0332157 (UMLS CUI [6,1])
C3712108 (UMLS CUI [6,2])
C0332157 (UMLS CUI [7,1])
C3852670 (UMLS CUI [7,2])
C0013230 (UMLS CUI [8])
C3653501 (UMLS CUI [9])
Child-Pugh Classification | Hepatic decompensation | Ascites | Bleeding varices | Hepatic Encephalopathy
Item
any current or past clinical evidence of child-pugh b or c classification or clinical history of liver decompensation including ascites, variceal bleeding, or hepatic encephalopathy.
boolean
C4050412 (UMLS CUI [1])
C1394798 (UMLS CUI [2])
C0003962 (UMLS CUI [3])
C0333106 (UMLS CUI [4])
C0019151 (UMLS CUI [5])
Liver carcinoma
Item
confirmed presence of hepatocellular carcinoma.
boolean
C2239176 (UMLS CUI [1])
Liver disease | Cause Except Chronic Hepatitis C
Item
any cause of liver disease other than chronic hcv infection.
boolean
C0023895 (UMLS CUI [1])
C0015127 (UMLS CUI [2,1])
C0332300 (UMLS CUI [2,2])
C0524910 (UMLS CUI [2,3])
Laboratory test result abnormal
Item
abnormal laboratory tests.
boolean
C0438215 (UMLS CUI [1])
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