ID

39749

Beskrivning

Filibuvir In Treatment Naive Hepatitis C Virus (HCV) Genotype 1 Subjects; ODM derived from: https://clinicaltrials.gov/show/NCT00987337

Länk

https://clinicaltrials.gov/show/NCT00987337

Nyckelord

Versioner (1)
  1. 2020-02-16 2020-02-16 -
Rättsinnehavare

See clinicaltrials.gov

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16 februari 2020

DOI

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Creative Commons BY 4.0
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Eligibility Hepatitis NCT00987337

Engelsk

Eligibility Hepatitis NCT00987337

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility Hepatitis NCT00987337
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female subjects at least 18 years of age.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
hcv seropositive.
Beskrivning

HCV Seropositive

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0220847
UMLS CUI [1,2]
C0521143
hcv rna >10,000 iu/ml at screening.
Beskrivning

Hepatitis C virus RNA assay

Datatyp

boolean

Alias
UMLS CUI [1]
C1272251
hcv genotype 1. subjects infected with a non-genotype 1 strain or mixed genotypes are not eligible.
Beskrivning

Hepatitis C Genotype

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0019196
UMLS CUI [1,2]
C1533728
treatment naïve (no prior treatment with ifn alfa +/ rbv regimens or investigational anti-hcv agents).
Beskrivning

Therapy naive | Absence Interferon-alpha plus Ribavirin | Absence Anti-hepatitis C (HCV) Agents Investigational

Datatyp

boolean

Alias
UMLS CUI [1]
C0919936
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C0002199
UMLS CUI [2,3]
C0332287
UMLS CUI [2,4]
C0035525
UMLS CUI [3,1]
C0332197
UMLS CUI [3,2]
C4324240
UMLS CUI [3,3]
C1517586
liver biopsy within two years (24 months) of screening with non-cirrhotic fibrosis classification. for those subjects with liver biopsy outside of the time window or for those subjects with no history of liver biopsy, a biopsy must be performed prior to randomization.
Beskrivning

Biopsy of liver | Fibrosis Without Liver Cirrhosis

Datatyp

boolean

Alias
UMLS CUI [1]
C0193388
UMLS CUI [2,1]
C0016059
UMLS CUI [2,2]
C0332288
UMLS CUI [2,3]
C0023890
ultrasound within 6 months of screening for 1) those subjects with bridging fibrosis or 2) those subjects with afp >50 and <100 ng/ml with no evidence of hepatocellular carcinoma. for those subjects with an ultrasound conducted outside the 6-month time window, an ultrasound must be performed prior to randomization.
Beskrivning

Ultrasonography | Bridging fibrosis | Alpha one fetoprotein measurement | Liver carcinoma Absent

Datatyp

boolean

Alias
UMLS CUI [1]
C0041618
UMLS CUI [2]
C0334160
UMLS CUI [3]
C0201539
UMLS CUI [4,1]
C2239176
UMLS CUI [4,2]
C0332197
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
co-infection with either hiv or hbv.
Beskrivning

HIV coinfection | HBV coinfection

Datatyp

boolean

Alias
UMLS CUI [1]
C4062778
UMLS CUI [2]
C2242656
evidence of severe or decompensated liver disease.
Beskrivning

Liver disease Severe | Decompensated liver disease

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C4075847
subjects with liver disease unrelated to hcv infection.
Beskrivning

Liver disease | Relationship Absent Hepatitis C

Datatyp

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2,1]
C0439849
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0019196
pre-existing medical condition that makes the subject unsuitable for treatment with pegifn/rbv therapy per product labeling.
Beskrivning

Medical condition Pre-existing | Study Subject Inappropriate PEGINTERFERON/RIBAVIRIN

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C2347662
UMLS CUI [2,1]
C0681850
UMLS CUI [2,2]
C1548788
UMLS CUI [2,3]
C1875630
laboratory abnormality at screening that makes the subject unsuitable for treatment with pegifn/rbv therapy per product labeling.
Beskrivning

Laboratory test result abnormal | Study Subject Inappropriate PEGINTERFERON/RIBAVIRIN

Datatyp

boolean

Alias
UMLS CUI [1]
C0438215
UMLS CUI [2,1]
C0681850
UMLS CUI [2,2]
C1548788
UMLS CUI [2,3]
C1875630
abnormal ecg suggestive of clinically significant cardiac disease or qtc>450msec.
Beskrivning

ECG abnormal Suggestive of Heart Disease | ECG abnormal Suggestive of Prolonged QTc interval

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0522055
UMLS CUI [1,2]
C0332299
UMLS CUI [1,3]
C0018799
UMLS CUI [2,1]
C0522055
UMLS CUI [2,2]
C0332299
UMLS CUI [2,3]
C1560305
history of organ transplant.
Beskrivning

Organ Transplantation

Datatyp

boolean

Alias
UMLS CUI [1]
C0029216
contraindicated medications being taken by the subject at the time of randomization that must be continued during the study period, including potent cyp3a4 inhibitors, sensitive cyp3a4 substrates, cyp3a4 substrates with narrow therapeutic range and cyp3a4 inducers.
Beskrivning

Pharmaceutical Preparations Contraindicated | CYP3A4 Inhibitors Strong | CYP3A4 Substrate Sensitive | CYP3A4 Substrate Therapeutic range Limited | CYP3A4 Inducers

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1444657
UMLS CUI [2,1]
C3850053
UMLS CUI [2,2]
C0442821
UMLS CUI [3,1]
C3714798
UMLS CUI [3,2]
C3891814
UMLS CUI [3,3]
C0332324
UMLS CUI [4,1]
C3714798
UMLS CUI [4,2]
C3891814
UMLS CUI [4,3]
C0460097
UMLS CUI [4,4]
C0439801
UMLS CUI [5]
C3850041
active alcohol or substance abuse sufficient, in the investigator's judgment, to prevent adherence to study medication and/or follow up.
Beskrivning

Substance Use Disorders Preventing Adherence Investigational New Drugs | Substance Use Disorders Preventing Follow-up

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0038586
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C1510802
UMLS CUI [1,4]
C0013230
UMLS CUI [2,1]
C0038586
UMLS CUI [2,2]
C1292733
UMLS CUI [2,3]
C3274571
pregnant or nursing females.
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
males whose female partner is pregnant.
Beskrivning

Gender Partner Pregnancy

Datatyp

boolean

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

Eligibility Hepatitis NCT00987337

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility Hepatitis NCT00987337
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
male or female subjects at least 18 years of age.
boolean
C0001779 (UMLS CUI [1])
HCV Seropositive
Item
hcv seropositive.
boolean
C0220847 (UMLS CUI [1,1])
C0521143 (UMLS CUI [1,2])
Hepatitis C virus RNA assay
Item
hcv rna >10,000 iu/ml at screening.
boolean
C1272251 (UMLS CUI [1])
Hepatitis C Genotype
Item
hcv genotype 1. subjects infected with a non-genotype 1 strain or mixed genotypes are not eligible.
boolean
C0019196 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
Therapy naive | Absence Interferon-alpha plus Ribavirin | Absence Anti-hepatitis C (HCV) Agents Investigational
Item
treatment naïve (no prior treatment with ifn alfa +/ rbv regimens or investigational anti-hcv agents).
boolean
C0919936 (UMLS CUI [1])
C0332197 (UMLS CUI [2,1])
C0002199 (UMLS CUI [2,2])
C0332287 (UMLS CUI [2,3])
C0035525 (UMLS CUI [2,4])
C0332197 (UMLS CUI [3,1])
C4324240 (UMLS CUI [3,2])
C1517586 (UMLS CUI [3,3])
Biopsy of liver | Fibrosis Without Liver Cirrhosis
Item
liver biopsy within two years (24 months) of screening with non-cirrhotic fibrosis classification. for those subjects with liver biopsy outside of the time window or for those subjects with no history of liver biopsy, a biopsy must be performed prior to randomization.
boolean
C0193388 (UMLS CUI [1])
C0016059 (UMLS CUI [2,1])
C0332288 (UMLS CUI [2,2])
C0023890 (UMLS CUI [2,3])
Ultrasonography | Bridging fibrosis | Alpha one fetoprotein measurement | Liver carcinoma Absent
Item
ultrasound within 6 months of screening for 1) those subjects with bridging fibrosis or 2) those subjects with afp >50 and <100 ng/ml with no evidence of hepatocellular carcinoma. for those subjects with an ultrasound conducted outside the 6-month time window, an ultrasound must be performed prior to randomization.
boolean
C0041618 (UMLS CUI [1])
C0334160 (UMLS CUI [2])
C0201539 (UMLS CUI [3])
C2239176 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Item Group
C0680251 (UMLS CUI)
HIV coinfection | HBV coinfection
Item
co-infection with either hiv or hbv.
boolean
C4062778 (UMLS CUI [1])
C2242656 (UMLS CUI [2])
Liver disease Severe | Decompensated liver disease
Item
evidence of severe or decompensated liver disease.
boolean
C0023895 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C4075847 (UMLS CUI [2])
Liver disease | Relationship Absent Hepatitis C
Item
subjects with liver disease unrelated to hcv infection.
boolean
C0023895 (UMLS CUI [1])
C0439849 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0019196 (UMLS CUI [2,3])
Medical condition Pre-existing | Study Subject Inappropriate PEGINTERFERON/RIBAVIRIN
Item
pre-existing medical condition that makes the subject unsuitable for treatment with pegifn/rbv therapy per product labeling.
boolean
C3843040 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C0681850 (UMLS CUI [2,1])
C1548788 (UMLS CUI [2,2])
C1875630 (UMLS CUI [2,3])
Laboratory test result abnormal | Study Subject Inappropriate PEGINTERFERON/RIBAVIRIN
Item
laboratory abnormality at screening that makes the subject unsuitable for treatment with pegifn/rbv therapy per product labeling.
boolean
C0438215 (UMLS CUI [1])
C0681850 (UMLS CUI [2,1])
C1548788 (UMLS CUI [2,2])
C1875630 (UMLS CUI [2,3])
ECG abnormal Suggestive of Heart Disease | ECG abnormal Suggestive of Prolonged QTc interval
Item
abnormal ecg suggestive of clinically significant cardiac disease or qtc>450msec.
boolean
C0522055 (UMLS CUI [1,1])
C0332299 (UMLS CUI [1,2])
C0018799 (UMLS CUI [1,3])
C0522055 (UMLS CUI [2,1])
C0332299 (UMLS CUI [2,2])
C1560305 (UMLS CUI [2,3])
Organ Transplantation
Item
history of organ transplant.
boolean
C0029216 (UMLS CUI [1])
Pharmaceutical Preparations Contraindicated | CYP3A4 Inhibitors Strong | CYP3A4 Substrate Sensitive | CYP3A4 Substrate Therapeutic range Limited | CYP3A4 Inducers
Item
contraindicated medications being taken by the subject at the time of randomization that must be continued during the study period, including potent cyp3a4 inhibitors, sensitive cyp3a4 substrates, cyp3a4 substrates with narrow therapeutic range and cyp3a4 inducers.
boolean
C0013227 (UMLS CUI [1,1])
C1444657 (UMLS CUI [1,2])
C3850053 (UMLS CUI [2,1])
C0442821 (UMLS CUI [2,2])
C3714798 (UMLS CUI [3,1])
C3891814 (UMLS CUI [3,2])
C0332324 (UMLS CUI [3,3])
C3714798 (UMLS CUI [4,1])
C3891814 (UMLS CUI [4,2])
C0460097 (UMLS CUI [4,3])
C0439801 (UMLS CUI [4,4])
C3850041 (UMLS CUI [5])
Substance Use Disorders Preventing Adherence Investigational New Drugs | Substance Use Disorders Preventing Follow-up
Item
active alcohol or substance abuse sufficient, in the investigator's judgment, to prevent adherence to study medication and/or follow up.
boolean
C0038586 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C1510802 (UMLS CUI [1,3])
C0013230 (UMLS CUI [1,4])
C0038586 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C3274571 (UMLS CUI [2,3])
Pregnancy | Breast Feeding
Item
pregnant or nursing females.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Gender Partner Pregnancy
Item
males whose female partner is pregnant.
boolean
C0079399 (UMLS CUI [1,1])
C0682323 (UMLS CUI [1,2])
C0032961 (UMLS CUI [1,3])
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