ID

40999

Description

Open-Label, Bridging Study of Telaprevir in Treatment-Naïve and Treatment-Experienced Russian Patients With Genotype 1 Chronic Hepatitis C; ODM derived from: https://clinicaltrials.gov/show/NCT01498068

Link

https://clinicaltrials.gov/show/NCT01498068

Keywords

Versions (1)
  1. 6/9/20 6/9/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 9, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Genotype 1 Chronic Hepatitis C NCT01498068

English

Eligibility Genotype 1 Chronic Hepatitis C NCT01498068

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
participant has genotype 1 chronic hepatitis c with hcv rna level >1000 iu/ml
Description

Chronic Hepatitis C Genotype | Hepatitis C virus RNA assay

Data type

boolean

Alias
UMLS CUI [1,1]
C0524910
UMLS CUI [1,2]
C1533728
UMLS CUI [2]
C1272251
participant is either treatment-naïve and did not receive any previous treatment with any approved or investigational drug or drug regimen for the treatment of hepatitis c, or participant is treatment-experienced who did not achieve sustained virologic response (svr) 24 weeks after at least 1 prior course of peg-ifn/rbv therapy (null-responder, partial-responder or viral relapse)
Description

Therapy naive | Hepatitis C Untreated | Therapy Received | Sustained Virologic Response failed | Status post Course Quantity | PEGINTERFERON/RIBAVIRIN | Therapy non-responder | Therapy partial responder | Viral Relapse

Data type

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]
C1514756
UMLS CUI [4,1]
C4050171
UMLS CUI [4,2]
C0231175
UMLS CUI [5,1]
C0231290
UMLS CUI [5,2]
C0750729
UMLS CUI [5,3]
C1265611
UMLS CUI [6]
C1875630
UMLS CUI [7]
C0919875
UMLS CUI [8]
C4285679
UMLS CUI [9]
C4053867
participant must have documentation of liver biopsy or fibroscan within 2 years before the screening visit or agree to have a biopsy or fibroscan within the screening period unless histological cirrhosis was demonstrated by a biopsy or fibroscan > 2 years ago prior to screening
Description

Biopsy of liver | Fibroscan

Data type

boolean

Alias
UMLS CUI [1]
C0193388
UMLS CUI [2]
C4522043
a female participant of childbearing potential and a nonvasectomized male participant who has a female partner of childbearing potential must agree to the use of 2 effective methods of birth control from screening until 6 months (female participant ) or 7 months (male participant) after the last dose of rbv
Description

Childbearing Potential Contraceptive methods Quantity | Gender Partner Childbearing Potential Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0682323
UMLS CUI [2,3]
C3831118
UMLS CUI [2,4]
C0700589
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior non-responder that is classified as a viral breakthrough participant
Description

Therapy non-responder Previous | Classification Viral Breakthrough

Data type

boolean

Alias
UMLS CUI [1,1]
C0919875
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C0008902
UMLS CUI [2,2]
C4053869
participant is infected or co-infected with hcv of another genotype than genotype 1
Description

Hepatitis C Genotype | HCV coinfection Genotype

Data type

boolean

Alias
UMLS CUI [1,1]
C0019196
UMLS CUI [1,2]
C1533728
UMLS CUI [2,1]
C1698259
UMLS CUI [2,2]
C1533728
participant has history of decompensated liver disease or shows evidence of significant liver disease in addition to hepatitis c
Description

Decompensated liver disease | Liver disease In addition to Hepatitis C

Data type

boolean

Alias
UMLS CUI [1]
C4075847
UMLS CUI [2,1]
C0023895
UMLS CUI [2,2]
C0332287
UMLS CUI [2,3]
C0019196
participant has human immunodeficiency virus (hiv) or hepatitis b virus (hbv) co-infection
Description

HIV coinfection | HBV coinfection

Data type

boolean

Alias
UMLS CUI [1]
C4062778
UMLS CUI [2]
C2242656
participant has active malignant disease or history of malignant disease within the past 5 years (with the exception of treated basal cell carcinoma or hepatocellular carcinoma
Description

Malignant disease | Exception Basal cell carcinoma Treated | Exception Liver carcinoma Treated

Data type

boolean

Alias
UMLS CUI [1]
C0442867
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C2239176
UMLS CUI [3,3]
C1522326
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Similar models

Eligibility Genotype 1 Chronic Hepatitis C NCT01498068

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Chronic Hepatitis C Genotype | Hepatitis C virus RNA assay
Item
participant has genotype 1 chronic hepatitis c with hcv rna level >1000 iu/ml
boolean
C0524910 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
C1272251 (UMLS CUI [2])
Therapy naive | Hepatitis C Untreated | Therapy Received | Sustained Virologic Response failed | Status post Course Quantity | PEGINTERFERON/RIBAVIRIN | Therapy non-responder | Therapy partial responder | Viral Relapse
Item
participant is either treatment-naïve and did not receive any previous treatment with any approved or investigational drug or drug regimen for the treatment of hepatitis c, or participant is treatment-experienced who did not achieve sustained virologic response (svr) 24 weeks after at least 1 prior course of peg-ifn/rbv therapy (null-responder, partial-responder or viral relapse)
boolean
C0919936 (UMLS CUI [1])
C0019196 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
C0087111 (UMLS CUI [3,1])
C1514756 (UMLS CUI [3,2])
C4050171 (UMLS CUI [4,1])
C0231175 (UMLS CUI [4,2])
C0231290 (UMLS CUI [5,1])
C0750729 (UMLS CUI [5,2])
C1265611 (UMLS CUI [5,3])
C1875630 (UMLS CUI [6])
C0919875 (UMLS CUI [7])
C4285679 (UMLS CUI [8])
C4053867 (UMLS CUI [9])
Biopsy of liver | Fibroscan
Item
participant must have documentation of liver biopsy or fibroscan within 2 years before the screening visit or agree to have a biopsy or fibroscan within the screening period unless histological cirrhosis was demonstrated by a biopsy or fibroscan > 2 years ago prior to screening
boolean
C0193388 (UMLS CUI [1])
C4522043 (UMLS CUI [2])
Childbearing Potential Contraceptive methods Quantity | Gender Partner Childbearing Potential Contraceptive methods
Item
a female participant of childbearing potential and a nonvasectomized male participant who has a female partner of childbearing potential must agree to the use of 2 effective methods of birth control from screening until 6 months (female participant ) or 7 months (male participant) after the last dose of rbv
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0079399 (UMLS CUI [2,1])
C0682323 (UMLS CUI [2,2])
C3831118 (UMLS CUI [2,3])
C0700589 (UMLS CUI [2,4])
Item Group
C0680251 (UMLS CUI)
Therapy non-responder Previous | Classification Viral Breakthrough
Item
prior non-responder that is classified as a viral breakthrough participant
boolean
C0919875 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0008902 (UMLS CUI [2,1])
C4053869 (UMLS CUI [2,2])
Hepatitis C Genotype | HCV coinfection Genotype
Item
participant is infected or co-infected with hcv of another genotype than genotype 1
boolean
C0019196 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
C1698259 (UMLS CUI [2,1])
C1533728 (UMLS CUI [2,2])
Decompensated liver disease | Liver disease In addition to Hepatitis C
Item
participant has history of decompensated liver disease or shows evidence of significant liver disease in addition to hepatitis c
boolean
C4075847 (UMLS CUI [1])
C0023895 (UMLS CUI [2,1])
C0332287 (UMLS CUI [2,2])
C0019196 (UMLS CUI [2,3])
HIV coinfection | HBV coinfection
Item
participant has human immunodeficiency virus (hiv) or hepatitis b virus (hbv) co-infection
boolean
C4062778 (UMLS CUI [1])
C2242656 (UMLS CUI [2])
Malignant disease | Exception Basal cell carcinoma Treated | Exception Liver carcinoma Treated
Item
participant has active malignant disease or history of malignant disease within the past 5 years (with the exception of treated basal cell carcinoma or hepatocellular carcinoma
boolean
C0442867 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C2239176 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
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