ID

39717

Beskrivning

Safety and Efficacy of Boceprevir in Asia Pacific Participants With Chronic Hepatitis C Genotype 1 (P07063); ODM derived from: https://clinicaltrials.gov/show/NCT01390844

Länk

https://clinicaltrials.gov/show/NCT01390844

Nyckelord

Versioner (1)
  1. 2020-02-12 2020-02-12 -
Rättsinnehavare

See clinicaltrials.gov

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12 februari 2020

DOI

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Creative Commons BY 4.0
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Eligibility Hepatitis C, Chronic NCT01390844

Engelsk

Eligibility Hepatitis C, Chronic NCT01390844

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
previously documented chc genotype 1 infection. other or mixed genotypes are not eligible.
Beskrivning

Chronic Hepatitis C Genotype

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0524910
UMLS CUI [1,2]
C1533728
liver biopsy with histology consistent with chc and no other etiology.
Beskrivning

Biopsy of liver | Histology Consistent with Chronic Hepatitis C

Datatyp

boolean

Alias
UMLS CUI [1]
C0193388
UMLS CUI [2,1]
C0344441
UMLS CUI [2,2]
C0332290
UMLS CUI [2,3]
C0524910
participants with cirrhosis must have an ultrasound/imaging study within 6 months of screening (or between screening and day 1) with no findings suspicious for hepatocellular carcinoma
Beskrivning

Liver Cirrhosis Ultrasonography | Liver Cirrhosis Imaging study | Absence Liver findings Suspicious Liver carcinoma

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0023890
UMLS CUI [1,2]
C0041618
UMLS CUI [2,1]
C0023890
UMLS CUI [2,2]
C1881134
UMLS CUI [3,1]
C0332197
UMLS CUI [3,2]
C0426686
UMLS CUI [3,3]
C0750493
UMLS CUI [3,4]
C2239176
failed previous treatment (of at least 12 weeks) with pegylated interferon (alfa-2a or alfa-2b) plus rbv
Beskrivning

Prior Therapy failed | Peginterferon alfa-2a plus Ribavirin | Peginterferon alfa-2b plus Ribavirin

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0231175
UMLS CUI [2,1]
C0391001
UMLS CUI [2,2]
C0332287
UMLS CUI [2,3]
C0035525
UMLS CUI [3,1]
C0796545
UMLS CUI [3,2]
C0332287
UMLS CUI [3,3]
C0035525
weight between 40 kg and 125 kg, inclusive
Beskrivning

Body Weight

Datatyp

boolean

Alias
UMLS CUI [1]
C0005910
of 'local' ancestral descent
Beskrivning

Ancestors Local

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0870134
UMLS CUI [1,2]
C0205276
sexually active males and females of child-bearing potential must agree to use a medically accepted method of contraception
Beskrivning

Gender Sexually active Contraceptive methods | Childbearing Potential Contraceptive methods

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0241028
UMLS CUI [1,3]
C0700589
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
co-infected with the human immunodeficiency virus (hiv) or hepatitis b virus
Beskrivning

Human immunodeficiency virus (HIV) coinfection | HBV coinfection

Datatyp

boolean

Alias
UMLS CUI [1]
C4062778
UMLS CUI [2]
C2242656
required discontinuation of previous interferon or rbv regimen for an adverse event considered to be possibly or probably related to rbv and/or interferon
Beskrivning

Interferon To be stopped | Ribavirin To be stopped | Adverse event Relationship Ribavirin | Adverse event Relationship Interferon

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3652465
UMLS CUI [1,2]
C1272691
UMLS CUI [2,1]
C0035525
UMLS CUI [2,2]
C1272691
UMLS CUI [3,1]
C0877248
UMLS CUI [3,2]
C0439849
UMLS CUI [3,3]
C0035525
UMLS CUI [4,1]
C0877248
UMLS CUI [4,2]
C0439849
UMLS CUI [4,3]
C3652465
treatment with rbv within 90 days and any interferon-alpha within 1 month prior to screening
Beskrivning

Ribavirin Recent | Interferon-alpha Recent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0035525
UMLS CUI [1,2]
C0332185
UMLS CUI [2,1]
C0002199
UMLS CUI [2,2]
C0332185
treatment for hepatitis c with any investigational medication or prior treatment with herbal remedies with known hepatotoxicity
Beskrivning

Therapeutic procedure Hepatitis C | Investigational New Drugs | Herbal medicine Associated with Hepatotoxicity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0019196
UMLS CUI [2]
C0013230
UMLS CUI [3,1]
C2240391
UMLS CUI [3,2]
C0332281
UMLS CUI [3,3]
C0235378
treatment with any investigational drug or participation in any interventional clinical trial within 30 days of the screening visit
Beskrivning

Investigational New Drugs | Study Subject Participation Status | Interventional Study

Datatyp

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C2348568
UMLS CUI [3]
C3274035
evidence of decompensated liver disease including, but not limited to, a history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy
Beskrivning

Decompensated liver disease | Ascites | Bleeding varices | Hepatic Encephalopathy

Datatyp

boolean

Alias
UMLS CUI [1]
C4075847
UMLS CUI [2]
C0003962
UMLS CUI [3]
C0333106
UMLS CUI [4]
C0019151
diabetes and/or hypertension with clinically significant ocular examination findings
Beskrivning

Diabetes | Hypertensive disease | On examination - eye findings Clinical Significance

Datatyp

boolean

Alias
UMLS CUI [1]
C0011847
UMLS CUI [2]
C0020538
UMLS CUI [3,1]
C0437530
UMLS CUI [3,2]
C2826293
any condition the could interfere with participation in and completion of the trial
Beskrivning

Condition Interferes with Study Subject Participation Status | Condition Interferes with Completion of clinical trial

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2348568
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C2732579
evidence of active or suspected malignancy, or history of malignancy within the last 5 years (except adequately treatment carcinoma in situ and basal cell carcinoma of the skin)
Beskrivning

Malignant Neoplasms | Malignant Neoplasm Suspected | Exception Carcinoma in Situ Treated | Exception Basal cell carcinoma Treated

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C0006826
UMLS CUI [2,2]
C0750491
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007099
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0007117
UMLS CUI [4,3]
C1522326
pregnant or breast-feeding
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
Tillbaka till toppen

Similar models

Eligibility Hepatitis C, Chronic NCT01390844

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Chronic Hepatitis C Genotype
Item
previously documented chc genotype 1 infection. other or mixed genotypes are not eligible.
boolean
C0524910 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
Biopsy of liver | Histology Consistent with Chronic Hepatitis C
Item
liver biopsy with histology consistent with chc and no other etiology.
boolean
C0193388 (UMLS CUI [1])
C0344441 (UMLS CUI [2,1])
C0332290 (UMLS CUI [2,2])
C0524910 (UMLS CUI [2,3])
Liver Cirrhosis Ultrasonography | Liver Cirrhosis Imaging study | Absence Liver findings Suspicious Liver carcinoma
Item
participants with cirrhosis must have an ultrasound/imaging study within 6 months of screening (or between screening and day 1) with no findings suspicious for hepatocellular carcinoma
boolean
C0023890 (UMLS CUI [1,1])
C0041618 (UMLS CUI [1,2])
C0023890 (UMLS CUI [2,1])
C1881134 (UMLS CUI [2,2])
C0332197 (UMLS CUI [3,1])
C0426686 (UMLS CUI [3,2])
C0750493 (UMLS CUI [3,3])
C2239176 (UMLS CUI [3,4])
Prior Therapy failed | Peginterferon alfa-2a plus Ribavirin | Peginterferon alfa-2b plus Ribavirin
Item
failed previous treatment (of at least 12 weeks) with pegylated interferon (alfa-2a or alfa-2b) plus rbv
boolean
C1514463 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
C0391001 (UMLS CUI [2,1])
C0332287 (UMLS CUI [2,2])
C0035525 (UMLS CUI [2,3])
C0796545 (UMLS CUI [3,1])
C0332287 (UMLS CUI [3,2])
C0035525 (UMLS CUI [3,3])
Body Weight
Item
weight between 40 kg and 125 kg, inclusive
boolean
C0005910 (UMLS CUI [1])
Ancestors Local
Item
of 'local' ancestral descent
boolean
C0870134 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
Gender Sexually active Contraceptive methods | Childbearing Potential Contraceptive methods
Item
sexually active males and females of child-bearing potential must agree to use a medically accepted method of contraception
boolean
C0079399 (UMLS CUI [1,1])
C0241028 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Human immunodeficiency virus (HIV) coinfection | HBV coinfection
Item
co-infected with the human immunodeficiency virus (hiv) or hepatitis b virus
boolean
C4062778 (UMLS CUI [1])
C2242656 (UMLS CUI [2])
Interferon To be stopped | Ribavirin To be stopped | Adverse event Relationship Ribavirin | Adverse event Relationship Interferon
Item
required discontinuation of previous interferon or rbv regimen for an adverse event considered to be possibly or probably related to rbv and/or interferon
boolean
C3652465 (UMLS CUI [1,1])
C1272691 (UMLS CUI [1,2])
C0035525 (UMLS CUI [2,1])
C1272691 (UMLS CUI [2,2])
C0877248 (UMLS CUI [3,1])
C0439849 (UMLS CUI [3,2])
C0035525 (UMLS CUI [3,3])
C0877248 (UMLS CUI [4,1])
C0439849 (UMLS CUI [4,2])
C3652465 (UMLS CUI [4,3])
Ribavirin Recent | Interferon-alpha Recent
Item
treatment with rbv within 90 days and any interferon-alpha within 1 month prior to screening
boolean
C0035525 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0002199 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
Therapeutic procedure Hepatitis C | Investigational New Drugs | Herbal medicine Associated with Hepatotoxicity
Item
treatment for hepatitis c with any investigational medication or prior treatment with herbal remedies with known hepatotoxicity
boolean
C0087111 (UMLS CUI [1,1])
C0019196 (UMLS CUI [1,2])
C0013230 (UMLS CUI [2])
C2240391 (UMLS CUI [3,1])
C0332281 (UMLS CUI [3,2])
C0235378 (UMLS CUI [3,3])
Investigational New Drugs | Study Subject Participation Status | Interventional Study
Item
treatment with any investigational drug or participation in any interventional clinical trial within 30 days of the screening visit
boolean
C0013230 (UMLS CUI [1])
C2348568 (UMLS CUI [2])
C3274035 (UMLS CUI [3])
Decompensated liver disease | Ascites | Bleeding varices | Hepatic Encephalopathy
Item
evidence of decompensated liver disease including, but not limited to, a history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy
boolean
C4075847 (UMLS CUI [1])
C0003962 (UMLS CUI [2])
C0333106 (UMLS CUI [3])
C0019151 (UMLS CUI [4])
Diabetes | Hypertensive disease | On examination - eye findings Clinical Significance
Item
diabetes and/or hypertension with clinically significant ocular examination findings
boolean
C0011847 (UMLS CUI [1])
C0020538 (UMLS CUI [2])
C0437530 (UMLS CUI [3,1])
C2826293 (UMLS CUI [3,2])
Condition Interferes with Study Subject Participation Status | Condition Interferes with Completion of clinical trial
Item
any condition the could interfere with participation in and completion of the trial
boolean
C0348080 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C2732579 (UMLS CUI [2,3])
Malignant Neoplasms | Malignant Neoplasm Suspected | Exception Carcinoma in Situ Treated | Exception Basal cell carcinoma Treated
Item
evidence of active or suspected malignancy, or history of malignancy within the last 5 years (except adequately treatment carcinoma in situ and basal cell carcinoma of the skin)
boolean
C0006826 (UMLS CUI [1])
C0006826 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0007099 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0007117 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
Pregnancy | Breast Feeding
Item
pregnant or breast-feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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