ID

44367

Description

A Pilot Trial to Determine the Safety and Efficacy of Fluvastatin in Previous Partial Responders to Pegylated Interferon and Ribivirin in Patients With Genotype 1 Hepatitis C; ODM derived from: https://clinicaltrials.gov/show/NCT00814606

Link

https://clinicaltrials.gov/show/NCT00814606

Keywords

Versions (2)
  1. 1/31/20 1/31/20 -
  2. 9/20/21 9/20/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatitis C NCT00814606

English

Eligibility Hepatitis C NCT00814606

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female of any ethnicity age 18 - 65 years with genotype 1 hcv
Description

Ethnicity Any | Age | Hepatitis C Genotype

Data type

boolean

Alias
UMLS CUI [1,1]
C0015031
UMLS CUI [1,2]
C1552551
UMLS CUI [2]
C0001779
UMLS CUI [3,1]
C0019196
UMLS CUI [3,2]
C1533728
previous partial responder to attempts at hcv therapy with peg/rbv (at least 1 log drop but less than 2 log drop in hcv rna at 12 weeks)
Description

Partial responder to therapy Hepatitis C | PEGINTERFERON/RIBAVIRIN | Hepatitis C virus RNA Assay

Data type

boolean

Alias
UMLS CUI [1,1]
C1740822
UMLS CUI [1,2]
C0019196
UMLS CUI [2]
C1875630
UMLS CUI [3,1]
C0369335
UMLS CUI [3,2]
C1510438
previous history or serum hcv-rna pcr quantifiable by roche amplicore hcv test
Description

Hepatitis C virus RNA Polymerase Chain Reaction | Other Coding

Data type

boolean

Alias
UMLS CUI [1,1]
C0369335
UMLS CUI [1,2]
C0032520
UMLS CUI [2]
C3846158
a liver biopsy within 3 years of study enrollment consistent with hcv disease.
Description

Biopsy of liver Consistent with Hepatitis C

Data type

boolean

Alias
UMLS CUI [1,1]
C0193388
UMLS CUI [1,2]
C0332290
UMLS CUI [1,3]
C0019196
compensated liver disease, child-pugh class ≤ 6
Description

Compensated liver disease Child-Pugh Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C3839044
UMLS CUI [1,2]
C4050412
negative urine pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of the study drug
Description

Childbearing Potential Urine pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430057
all patients enrolling in the study and all partners of study participants of childbearing potential must be using two reliable forms of effective contraception during the study. exceptions may include partner/participant is surgically sterile.
Description

Study Subject All Contraceptive methods Quantity | Partner Childbearing Potential Contraceptive methods Quantity | Exception Partner Sexual sterilization | Exception Study Subject Sexual sterilization

Data type

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0444868
UMLS CUI [1,3]
C0700589
UMLS CUI [1,4]
C1265611
UMLS CUI [2,1]
C0682323
UMLS CUI [2,2]
C3831118
UMLS CUI [2,3]
C0700589
UMLS CUI [2,4]
C1265611
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0682323
UMLS CUI [3,3]
C0038288
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0681850
UMLS CUI [4,3]
C0038288
willingness to comply with study procedures and provide written informed consent
Description

Protocol Compliance | Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
ast or alt > 10 uln
Description

Aspartate aminotransferase increased | Alanine aminotransferase increased

Data type

boolean

Alias
UMLS CUI [1]
C0151904
UMLS CUI [2]
C0151905
any investigational drug ≤ 12 weeks prior to the first of study drug
Description

Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013230
prior intolerance to statin medications
Description

Intolerance to Statins

Data type

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C0360714
previous serious side effects to ifn or rbv (e.g. psychiatric side effect necessitating treatment discontinuation, severe cytopenia refractory to growth factors, intolerance to ifn/rbv requiring treatment discontinuation)
Description

Side effects Serious Interferon | Side effects Serious Ribavirin | Side effects Psychiatric | Requirement Treatment Discontinuation | Cytopenia Severe | Unresponsive to Growth Factors | Intolerance to Interferon | Intolerance to Ribavirin

Data type

boolean

Alias
UMLS CUI [1,1]
C0879626
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0021747
UMLS CUI [2,1]
C0879626
UMLS CUI [2,2]
C0205404
UMLS CUI [2,3]
C0035525
UMLS CUI [3,1]
C0879626
UMLS CUI [3,2]
C0205487
UMLS CUI [4,1]
C1514873
UMLS CUI [4,2]
C0087111
UMLS CUI [4,3]
C0457454
UMLS CUI [5,1]
C0010828
UMLS CUI [5,2]
C0205082
UMLS CUI [6,1]
C0205269
UMLS CUI [6,2]
C0018284
UMLS CUI [7,1]
C1744706
UMLS CUI [7,2]
C0021747
UMLS CUI [8,1]
C1744706
UMLS CUI [8,2]
C0035525
any systemic antiviral therapy ≤ 24 weeks prior to the first dose of study drug or expectation that such treatment will be needed at any time during the study. exception: patients who have taken or are expected to require such treatment for herpetic lesions
Description

Antiviral Therapy Systemic | Antiviral Therapy Systemic Expected | Exception Treatment Lesion of liver

Data type

boolean

Alias
UMLS CUI [1,1]
C0280274
UMLS CUI [1,2]
C0205373
UMLS CUI [2,1]
C0280274
UMLS CUI [2,2]
C0205373
UMLS CUI [2,3]
C1517001
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0087111
UMLS CUI [3,3]
C0577053
positive test at screening for anti-hav igm ab, hbsag, anti-hbc-igm ab ,or anti-hiv ab
Description

Hepatitis A virus IgM antibody positive | Hepatitis B surface antigen positive | Anti-HBc IgM antibody positive | HIV Antibodies Positive

Data type

boolean

Alias
UMLS CUI [1]
C1096503
UMLS CUI [2]
C0149709
UMLS CUI [3]
C1096146
UMLS CUI [4,1]
C0019683
UMLS CUI [4,2]
C1514241
serum concentrations of cerulplamin or alph-1-antitrypsin consistent with an increased risk of metabolic liver disease
Description

Serum ceruloplasmin level result At risk Liver disease Metabolic | Alpha-1-antitrypsin measurement At risk Liver disease Metabolic

Data type

boolean

Alias
UMLS CUI [1,1]
C1318404
UMLS CUI [1,2]
C1444641
UMLS CUI [1,3]
C0023895
UMLS CUI [1,4]
C0311400
UMLS CUI [2,1]
C0201856
UMLS CUI [2,2]
C1444641
UMLS CUI [2,3]
C0023895
UMLS CUI [2,4]
C0311400
history or other evidence of a medical condition associated with chronic liver disease (e.g. hemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxin exposure, nonalcoholic steatohepatitis)
Description

Medical condition Associated with Chronic liver disease | Hemochromatosis | Hepatitis, Autoimmune | Alcoholic Liver Disease | Exposure to toxin | Nonalcoholic Steatohepatitis

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C0341439
UMLS CUI [2]
C0018995
UMLS CUI [3]
C0241910
UMLS CUI [4]
C0023896
UMLS CUI [5]
C0040537
UMLS CUI [6]
C3241937
women who are pregnant or breastfeeding and male partners of woman who are pregnant or breastfeeding
Description

Pregnancy | Breast Feeding | Gender Partner Pregnancy | Gender Partner Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0682323
UMLS CUI [3,3]
C0032961
UMLS CUI [4,1]
C0079399
UMLS CUI [4,2]
C0682323
UMLS CUI [4,3]
C0006147
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Similar models

Eligibility Hepatitis C NCT00814606

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Ethnicity Any | Age | Hepatitis C Genotype
Item
male or female of any ethnicity age 18 - 65 years with genotype 1 hcv
boolean
C0015031 (UMLS CUI [1,1])
C1552551 (UMLS CUI [1,2])
C0001779 (UMLS CUI [2])
C0019196 (UMLS CUI [3,1])
C1533728 (UMLS CUI [3,2])
Partial responder to therapy Hepatitis C | PEGINTERFERON/RIBAVIRIN | Hepatitis C virus RNA Assay
Item
previous partial responder to attempts at hcv therapy with peg/rbv (at least 1 log drop but less than 2 log drop in hcv rna at 12 weeks)
boolean
C1740822 (UMLS CUI [1,1])
C0019196 (UMLS CUI [1,2])
C1875630 (UMLS CUI [2])
C0369335 (UMLS CUI [3,1])
C1510438 (UMLS CUI [3,2])
Hepatitis C virus RNA Polymerase Chain Reaction | Other Coding
Item
previous history or serum hcv-rna pcr quantifiable by roche amplicore hcv test
boolean
C0369335 (UMLS CUI [1,1])
C0032520 (UMLS CUI [1,2])
C3846158 (UMLS CUI [2])
Biopsy of liver Consistent with Hepatitis C
Item
a liver biopsy within 3 years of study enrollment consistent with hcv disease.
boolean
C0193388 (UMLS CUI [1,1])
C0332290 (UMLS CUI [1,2])
C0019196 (UMLS CUI [1,3])
Compensated liver disease Child-Pugh Classification
Item
compensated liver disease, child-pugh class ≤ 6
boolean
C3839044 (UMLS CUI [1,1])
C4050412 (UMLS CUI [1,2])
Childbearing Potential Urine pregnancy test negative
Item
negative urine pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of the study drug
boolean
C3831118 (UMLS CUI [1,1])
C0430057 (UMLS CUI [1,2])
Study Subject All Contraceptive methods Quantity | Partner Childbearing Potential Contraceptive methods Quantity | Exception Partner Sexual sterilization | Exception Study Subject Sexual sterilization
Item
all patients enrolling in the study and all partners of study participants of childbearing potential must be using two reliable forms of effective contraception during the study. exceptions may include partner/participant is surgically sterile.
boolean
C0681850 (UMLS CUI [1,1])
C0444868 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
C0682323 (UMLS CUI [2,1])
C3831118 (UMLS CUI [2,2])
C0700589 (UMLS CUI [2,3])
C1265611 (UMLS CUI [2,4])
C1705847 (UMLS CUI [3,1])
C0682323 (UMLS CUI [3,2])
C0038288 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0681850 (UMLS CUI [4,2])
C0038288 (UMLS CUI [4,3])
Protocol Compliance | Informed Consent
Item
willingness to comply with study procedures and provide written informed consent
boolean
C0525058 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Aspartate aminotransferase increased | Alanine aminotransferase increased
Item
ast or alt > 10 uln
boolean
C0151904 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
Investigational New Drugs
Item
any investigational drug ≤ 12 weeks prior to the first of study drug
boolean
C0013230 (UMLS CUI [1])
Intolerance to Statins
Item
prior intolerance to statin medications
boolean
C1744706 (UMLS CUI [1,1])
C0360714 (UMLS CUI [1,2])
Side effects Serious Interferon | Side effects Serious Ribavirin | Side effects Psychiatric | Requirement Treatment Discontinuation | Cytopenia Severe | Unresponsive to Growth Factors | Intolerance to Interferon | Intolerance to Ribavirin
Item
previous serious side effects to ifn or rbv (e.g. psychiatric side effect necessitating treatment discontinuation, severe cytopenia refractory to growth factors, intolerance to ifn/rbv requiring treatment discontinuation)
boolean
C0879626 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0021747 (UMLS CUI [1,3])
C0879626 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0035525 (UMLS CUI [2,3])
C0879626 (UMLS CUI [3,1])
C0205487 (UMLS CUI [3,2])
C1514873 (UMLS CUI [4,1])
C0087111 (UMLS CUI [4,2])
C0457454 (UMLS CUI [4,3])
C0010828 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
C0205269 (UMLS CUI [6,1])
C0018284 (UMLS CUI [6,2])
C1744706 (UMLS CUI [7,1])
C0021747 (UMLS CUI [7,2])
C1744706 (UMLS CUI [8,1])
C0035525 (UMLS CUI [8,2])
Antiviral Therapy Systemic | Antiviral Therapy Systemic Expected | Exception Treatment Lesion of liver
Item
any systemic antiviral therapy ≤ 24 weeks prior to the first dose of study drug or expectation that such treatment will be needed at any time during the study. exception: patients who have taken or are expected to require such treatment for herpetic lesions
boolean
C0280274 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C0280274 (UMLS CUI [2,1])
C0205373 (UMLS CUI [2,2])
C1517001 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0087111 (UMLS CUI [3,2])
C0577053 (UMLS CUI [3,3])
Hepatitis A virus IgM antibody positive | Hepatitis B surface antigen positive | Anti-HBc IgM antibody positive | HIV Antibodies Positive
Item
positive test at screening for anti-hav igm ab, hbsag, anti-hbc-igm ab ,or anti-hiv ab
boolean
C1096503 (UMLS CUI [1])
C0149709 (UMLS CUI [2])
C1096146 (UMLS CUI [3])
C0019683 (UMLS CUI [4,1])
C1514241 (UMLS CUI [4,2])
Serum ceruloplasmin level result At risk Liver disease Metabolic | Alpha-1-antitrypsin measurement At risk Liver disease Metabolic
Item
serum concentrations of cerulplamin or alph-1-antitrypsin consistent with an increased risk of metabolic liver disease
boolean
C1318404 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C0023895 (UMLS CUI [1,3])
C0311400 (UMLS CUI [1,4])
C0201856 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
C0023895 (UMLS CUI [2,3])
C0311400 (UMLS CUI [2,4])
Medical condition Associated with Chronic liver disease | Hemochromatosis | Hepatitis, Autoimmune | Alcoholic Liver Disease | Exposure to toxin | Nonalcoholic Steatohepatitis
Item
history or other evidence of a medical condition associated with chronic liver disease (e.g. hemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxin exposure, nonalcoholic steatohepatitis)
boolean
C3843040 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0341439 (UMLS CUI [1,3])
C0018995 (UMLS CUI [2])
C0241910 (UMLS CUI [3])
C0023896 (UMLS CUI [4])
C0040537 (UMLS CUI [5])
C3241937 (UMLS CUI [6])
Pregnancy | Breast Feeding | Gender Partner Pregnancy | Gender Partner Breast Feeding
Item
women who are pregnant or breastfeeding and male partners of woman who are pregnant or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0079399 (UMLS CUI [3,1])
C0682323 (UMLS CUI [3,2])
C0032961 (UMLS CUI [3,3])
C0079399 (UMLS CUI [4,1])
C0682323 (UMLS CUI [4,2])
C0006147 (UMLS CUI [4,3])
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