ID

19987

Description

Phase 2 Study of VX-950, Pegasys®, and Copegus® in Hepatitis C; ODM derived from: https://clinicaltrials.gov/show/NCT00336479

Link

https://clinicaltrials.gov/show/NCT00336479

Keywords

Versions (3)
  1. 2/2/17 2/2/17 -
  2. 2/2/17 2/2/17 -
  3. 2/3/17 2/3/17 -
Uploaded on

February 2, 2017

DOI

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License

Creative Commons BY-NC 3.0
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Eligibility Chronic Hepatitis C NCT00336479

English

Eligibility Chronic Hepatitis C NCT00336479

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
hepatitis c virus genotype 1 with detectable plasma hepatitis c virus rna
Description

Hepatitis C virus genotype 1 | Hepatitis C RNA positive

Data type

boolean

Alias
UMLS CUI [1]
C3532919
UMLS CUI [2]
C0855842
have been infected with hepatitis c virus for greater than (>) 6 months
Description

Hepatitis C virus infection Disease length

Data type

boolean

Alias
UMLS CUI [1,1]
C3844790
UMLS CUI [1,2]
C0872146
seronegative for hepatitis b surface antigen and human immunodeficiency virus 1 and 2
Description

Hepatitis B Surface Antigens Seronegative | HIV-1 Seronegative | HIV-2 Seronegative

Data type

boolean

Alias
UMLS CUI [1,1]
C0019168
UMLS CUI [1,2]
C0521144
UMLS CUI [2,1]
C0019704
UMLS CUI [2,2]
C0521144
UMLS CUI [3,1]
C0019707
UMLS CUI [3,2]
C0521144
must agree to use 2 methods of contraception, including 1 barrier method, during and for 24 weeks after the completion of the study (unless the subject is a female of documented non-child-bearing potential)
Description

Childbearing Potential Contraceptive methods Quantity | Contraception, Barrier

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C1265611
UMLS CUI [2]
C0004764
female subjects must have a negative pregnancy test at all visits before the first dose
Description

Gender Pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0427780
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
received any approved or investigational drug or drug regimen for the treatment of hepatitis c
Description

Pharmaceutical Preparations Approved Hepatitis C | Investigational New Drugs Hepatitis C

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0205540
UMLS CUI [1,3]
C0019196
UMLS CUI [2,1]
C0013230
UMLS CUI [2,2]
C0019196
any medical contraindications to pegylated interferon alfa 2a or ribavirin therapy
Description

Medical contraindication peginterferon alfa-2a | Medical contraindication Ribavirin

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0391001
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0035525
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

Liver disease Significant Cause | Hepatitis C | 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]
C0023895
UMLS CUI [1,2]
C0750502
UMLS CUI [1,3]
C0015127
UMLS CUI [2]
C0019196
UMLS CUI [3]
C0019163
UMLS CUI [4]
C1960179
UMLS CUI [5]
C0023891
UMLS CUI [6]
C0241910
UMLS CUI [7]
C0018995
UMLS CUI [8]
C0019202
UMLS CUI [9]
C3241937
UMLS CUI [10]
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]
C0332147
histologic evidence of hepatic cirrhosis (including compensated cirrhosis) based on a liver biopsy taken within 2 years before study start
Description

Liver Cirrhosis Evidence Biopsy of liver | Compensated cirrhosis Biopsy of liver

Data type

boolean

Alias
UMLS CUI [1,1]
C0023890
UMLS CUI [1,2]
C0332120
UMLS CUI [1,3]
C0193388
UMLS CUI [2,1]
C1608426
UMLS CUI [2,2]
C0193388
alcohol abuse or excessive use in the last 12 months
Description

Alcohol abuse | Alcohol intake above recommended sensible limits

Data type

boolean

Alias
UMLS CUI [1]
C0085762
UMLS CUI [2]
C0560219
participation in any investigational drug study 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 | Drug study Quantity Participation

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3,1]
C0013175
UMLS CUI [3,2]
C1265611
UMLS CUI [3,3]
C0679823
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Similar models

Eligibility Chronic Hepatitis C NCT00336479

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Hepatitis C virus genotype 1 | Hepatitis C RNA positive
Item
hepatitis c virus genotype 1 with detectable plasma hepatitis c virus rna
boolean
C3532919 (UMLS CUI [1])
C0855842 (UMLS CUI [2])
Hepatitis C virus infection Disease length
Item
have been infected with hepatitis c virus for greater than (>) 6 months
boolean
C3844790 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Hepatitis B Surface Antigens Seronegative | HIV-1 Seronegative | HIV-2 Seronegative
Item
seronegative for hepatitis b surface antigen and human immunodeficiency virus 1 and 2
boolean
C0019168 (UMLS CUI [1,1])
C0521144 (UMLS CUI [1,2])
C0019704 (UMLS CUI [2,1])
C0521144 (UMLS CUI [2,2])
C0019707 (UMLS CUI [3,1])
C0521144 (UMLS CUI [3,2])
Childbearing Potential Contraceptive methods Quantity | Contraception, Barrier
Item
must agree to use 2 methods of contraception, including 1 barrier method, during and for 24 weeks after the completion of the study (unless the subject is a female of documented non-child-bearing potential)
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0004764 (UMLS CUI [2])
Gender Pregnancy test negative
Item
female subjects must have a negative pregnancy test at all visits before the first dose
boolean
C0079399 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Pharmaceutical Preparations Approved Hepatitis C | Investigational New Drugs Hepatitis C
Item
received any approved or investigational drug or drug regimen for the treatment of hepatitis c
boolean
C0013227 (UMLS CUI [1,1])
C0205540 (UMLS CUI [1,2])
C0019196 (UMLS CUI [1,3])
C0013230 (UMLS CUI [2,1])
C0019196 (UMLS CUI [2,2])
Medical contraindication peginterferon alfa-2a | Medical contraindication Ribavirin
Item
any medical contraindications to pegylated interferon alfa 2a or ribavirin therapy
boolean
C1301624 (UMLS CUI [1,1])
C0391001 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0035525 (UMLS CUI [2,2])
Liver disease Significant Cause | Hepatitis C | 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
C0023895 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0015127 (UMLS CUI [1,3])
C0019196 (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 (UMLS CUI [10])
Liver carcinoma | Liver carcinoma Suspected
Item
diagnosed or suspected hepatocellular carcinoma
boolean
C2239176 (UMLS CUI [1])
C2239176 (UMLS CUI [2,1])
C0332147 (UMLS CUI [2,2])
Liver Cirrhosis Evidence Biopsy of liver | Compensated cirrhosis Biopsy of liver
Item
histologic evidence of hepatic cirrhosis (including compensated cirrhosis) based on a liver biopsy taken within 2 years before study start
boolean
C0023890 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
C0193388 (UMLS CUI [1,3])
C1608426 (UMLS CUI [2,1])
C0193388 (UMLS CUI [2,2])
Alcohol abuse | Alcohol intake above recommended sensible limits
Item
alcohol abuse or excessive use in the last 12 months
boolean
C0085762 (UMLS CUI [1])
C0560219 (UMLS CUI [2])
Study Subject Participation Status | Investigational New Drugs | Drug study Quantity Participation
Item
participation in any investigational drug study 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])
C0013175 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0679823 (UMLS CUI [3,3])
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