ID

29694

Description

A Study of Telaprevir (VX-950), Pegasys and Copegus in Hepatitis C (PROVE3); ODM derived from: https://clinicaltrials.gov/show/NCT00420784

Link

https://clinicaltrials.gov/show/NCT00420784

Keywords

Versions (1)
  1. 4/13/18 4/13/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 13, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatitis C NCT00420784

English

Eligibility Hepatitis C NCT00420784

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
males and females between 18 and 70 years old
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
detectable plasma hepatitis c virus (hcv) ribonucleic acid (rna) greater than or equal to (>=) 10,000 international units per milliliter (iu/ml)
Description

Plasma Hepatitis C virus RNA Detectable IU/mL

Data type

boolean

Alias
UMLS CUI [1,1]
C0032105
UMLS CUI [1,2]
C0369335
UMLS CUI [1,3]
C3830527
UMLS CUI [1,4]
C0439458
must have chronic hepatitis c (genotype 1) and have already received at least one prior course of pegylated interferon alfa 2a with ribavirin
Description

Chronic Hepatitis C Genotype | Peginterferon alfa-2a Course Quantity | Ribavirin

Data type

boolean

Alias
UMLS CUI [1,1]
C0524910
UMLS CUI [1,2]
C0017431
UMLS CUI [2,1]
C0391001
UMLS CUI [2,2]
C0750729
UMLS CUI [2,3]
C1265611
UMLS CUI [3]
C0035525
cannot also be infected with human immunodeficiency virus or hepatitis b
Description

HIV Infection Absent | Hepatitis B Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0019693
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0019163
UMLS CUI [2,2]
C0332197
must be judged to be in general good health and able to receive pegasys® and copegus®
Description

General health good | Pegasys Receive Ability | Copegus Receive Ability

Data type

boolean

Alias
UMLS CUI [1]
C1277245
UMLS CUI [2,1]
C1176430
UMLS CUI [2,2]
C1514756
UMLS CUI [2,3]
C0085732
UMLS CUI [3,1]
C1170183
UMLS CUI [3,2]
C1514756
UMLS CUI [3,3]
C0085732
no drug or alcohol abuse in the last year
Description

Substance Use Disorders Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0038586
UMLS CUI [1,2]
C0332197
must agree to use two effective methods of birth control during the study and for 6 months after you stop taking study medication. one of the methods needs to be a
Description

Contraceptive methods Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C1265611
'barrier' method (condom or diaphragm)
Description

Contraception, Barrier | Condom | Vaginal contraceptive diaphragm

Data type

boolean

Alias
UMLS CUI [1]
C0004764
UMLS CUI [2]
C0677582
UMLS CUI [3]
C0042241
if you are a woman, you cannot be in this study if you are pregnant or nursing
Description

Gender | Pregnancy Absent | Breast Feeding Absent

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0032961
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0006147
UMLS CUI [3,2]
C0332197
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
participation in any clinical trial of a hcv protease inhibitor of any duration
Description

Study Subject Participation Status | HCV Protease Inhibitors

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0220847
UMLS CUI [2,2]
C0033607
prior response to therapy and failure to achieve svr which was due to treatment non-compliance
Description

Disease Response | Sustained Virologic Response failed | Compliance behavior Lacking

Data type

boolean

Alias
UMLS CUI [1]
C1704632
UMLS CUI [2,1]
C4050171
UMLS CUI [2,2]
C0231175
UMLS CUI [3,1]
C1321605
UMLS CUI [3,2]
C0332268
any other cause of significant liver disease in addition to hepatitis c; this may include but is not limited to, hepatitis b, drug or alcohol-related cirrhosis, autoimmune hepatitis, hemochromatosis, wilson's disease, nonalcoholic steatohepatitis, or primary biliary cirrhosis
Description

Cause Liver disease | Hepatitis B | Drug-induced cirrhosis of liver | Liver Cirrhosis, Alcoholic | Hepatitis, Autoimmune | Hemochromatosis | Hepatolenticular Degeneration | Nonalcoholic Steatohepatitis | Primary biliary cirrhosis

Data type

boolean

Alias
UMLS CUI [1,1]
C0015127
UMLS CUI [1,2]
C0023895
UMLS CUI [2]
C0019163
UMLS CUI [3]
C1960179
UMLS CUI [4]
C0023891
UMLS CUI [5]
C0241910
UMLS CUI [6]
C0018995
UMLS CUI [7]
C0019202
UMLS CUI [8]
C3241937
UMLS CUI [9]
C0008312
diagnosed or suspected hepatocellular carcinoma
Description

Liver carcinoma | Liver carcinoma Suspected

Data type

boolean

Alias
UMLS CUI [1]
C2239176
UMLS CUI [2,1]
C2239176
UMLS CUI [2,2]
C0750491
history of or current evidence of decompensated liver disease
Description

Decompensated liver disease

Data type

boolean

Alias
UMLS CUI [1]
C4075847
participation in any clinical trial of an investigational drug within 90 days before drug administration or participation in more than 2 drug studies in the last 12 months (exclusive of the current study)
Description

Study Subject Participation Status | Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
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Similar models

Eligibility Hepatitis C NCT00420784

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
males and females between 18 and 70 years old
boolean
C0001779 (UMLS CUI [1])
Plasma Hepatitis C virus RNA Detectable IU/mL
Item
detectable plasma hepatitis c virus (hcv) ribonucleic acid (rna) greater than or equal to (>=) 10,000 international units per milliliter (iu/ml)
boolean
C0032105 (UMLS CUI [1,1])
C0369335 (UMLS CUI [1,2])
C3830527 (UMLS CUI [1,3])
C0439458 (UMLS CUI [1,4])
Chronic Hepatitis C Genotype | Peginterferon alfa-2a Course Quantity | Ribavirin
Item
must have chronic hepatitis c (genotype 1) and have already received at least one prior course of pegylated interferon alfa 2a with ribavirin
boolean
C0524910 (UMLS CUI [1,1])
C0017431 (UMLS CUI [1,2])
C0391001 (UMLS CUI [2,1])
C0750729 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0035525 (UMLS CUI [3])
HIV Infection Absent | Hepatitis B Absent
Item
cannot also be infected with human immunodeficiency virus or hepatitis b
boolean
C0019693 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0019163 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
General health good | Pegasys Receive Ability | Copegus Receive Ability
Item
must be judged to be in general good health and able to receive pegasys® and copegus®
boolean
C1277245 (UMLS CUI [1])
C1176430 (UMLS CUI [2,1])
C1514756 (UMLS CUI [2,2])
C0085732 (UMLS CUI [2,3])
C1170183 (UMLS CUI [3,1])
C1514756 (UMLS CUI [3,2])
C0085732 (UMLS CUI [3,3])
Substance Use Disorders Absent
Item
no drug or alcohol abuse in the last year
boolean
C0038586 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Contraceptive methods Quantity
Item
must agree to use two effective methods of birth control during the study and for 6 months after you stop taking study medication. one of the methods needs to be a
boolean
C0700589 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Contraception, Barrier | Condom | Vaginal contraceptive diaphragm
Item
'barrier' method (condom or diaphragm)
boolean
C0004764 (UMLS CUI [1])
C0677582 (UMLS CUI [2])
C0042241 (UMLS CUI [3])
Gender | Pregnancy Absent | Breast Feeding Absent
Item
if you are a woman, you cannot be in this study if you are pregnant or nursing
boolean
C0079399 (UMLS CUI [1])
C0032961 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0006147 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Study Subject Participation Status | HCV Protease Inhibitors
Item
participation in any clinical trial of a hcv protease inhibitor of any duration
boolean
C2348568 (UMLS CUI [1])
C0220847 (UMLS CUI [2,1])
C0033607 (UMLS CUI [2,2])
Disease Response | Sustained Virologic Response failed | Compliance behavior Lacking
Item
prior response to therapy and failure to achieve svr which was due to treatment non-compliance
boolean
C1704632 (UMLS CUI [1])
C4050171 (UMLS CUI [2,1])
C0231175 (UMLS CUI [2,2])
C1321605 (UMLS CUI [3,1])
C0332268 (UMLS CUI [3,2])
Cause Liver disease | Hepatitis B | Drug-induced cirrhosis of liver | Liver Cirrhosis, Alcoholic | Hepatitis, Autoimmune | Hemochromatosis | Hepatolenticular Degeneration | Nonalcoholic Steatohepatitis | Primary biliary cirrhosis
Item
any other cause of significant liver disease in addition to hepatitis c; this may include but is not limited to, hepatitis b, drug or alcohol-related cirrhosis, autoimmune hepatitis, hemochromatosis, wilson's disease, nonalcoholic steatohepatitis, or primary biliary cirrhosis
boolean
C0015127 (UMLS CUI [1,1])
C0023895 (UMLS CUI [1,2])
C0019163 (UMLS CUI [2])
C1960179 (UMLS CUI [3])
C0023891 (UMLS CUI [4])
C0241910 (UMLS CUI [5])
C0018995 (UMLS CUI [6])
C0019202 (UMLS CUI [7])
C3241937 (UMLS CUI [8])
C0008312 (UMLS CUI [9])
Liver carcinoma | Liver carcinoma Suspected
Item
diagnosed or suspected hepatocellular carcinoma
boolean
C2239176 (UMLS CUI [1])
C2239176 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
Decompensated liver disease
Item
history of or current evidence of decompensated liver disease
boolean
C4075847 (UMLS CUI [1])
Study Subject Participation Status | Investigational New Drugs
Item
participation in any clinical trial of an investigational drug within 90 days before drug administration or participation in more than 2 drug studies in the last 12 months (exclusive of the current study)
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
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