ID

13715

Description

Pharmacokinetics of Boceprevir in Pediatric Subjects With Chronic Hepatitis C Genotype 1 (P07614); ODM derived from: https://clinicaltrials.gov/show/NCT01425190

Link

https://clinicaltrials.gov/show/NCT01425190

Keywords

Versions (1)
  1. 2/29/16 2/29/16 -
Uploaded on

February 29, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatitis C, Chronic NCT01425190

English

Eligibility Hepatitis C, Chronic NCT01425190

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
documented chronic hepatitis c (chc) genotype 1 infection
Description

chronic hepatitis c

Data type

boolean

Alias
UMLS CUI [1]
C0524910
treatment naïve or failed previous interferon/ribavirin therapy (≥12 uninterrupted weeks)
Description

therapy naive; therapy ribavirin

Data type

boolean

Alias
UMLS CUI [1]
C0919936
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0035525
weigh between 10 kg to 90 kg inclusive at screening and baseline (day -1).
Description

weight; screening

Data type

boolean

Alias
UMLS CUI [1]
C0005910
UMLS CUI [2]
C0220908
body mass index (bmi) from the 5th to the 95th percentile for the participant's age and gender, inclusive, per tables from the center for disease control and prevention, usa
Description

body mass index; center for disease control and prevention

Data type

boolean

Alias
UMLS CUI [1]
C1305855
UMLS CUI [2]
C0007670
use of acceptable methods of contraception for at least 3 months prior to baseline and continue on study
Description

contraception

Data type

boolean

Alias
UMLS CUI [1]
C0700589
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
co-infection with the human immunodeficiency virus (hiv) or hepatitis b virus (hbsag positive).
Description

HBV coinfection; human immunodeficiency virus infection

Data type

boolean

Alias
UMLS CUI [1]
C2242656
UMLS CUI [2]
C0019693
treatment with ribavirin within 90 days, or any interferon-alfa within 30 days
Description

therapy interferon-alfa

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0002199
discontinued from interferon treatment due to adverse events
Description

adverse events therapy interferon-alfa

Data type

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0002199
currently receiving antiviral/immunomodulating therapy for hepatitis c
Description

Antiviral Therapy

Data type

boolean

Alias
UMLS CUI [1]
C0280274
prior treatment with an hcv protease inhibitor
Description

therapy hcv protease inhibitor

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C3160091
prior treatment with any known hepatotoxic agent (including herbal remedies)
Description

drugs hepatotoxic; Herbal Drugs

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0235378
UMLS CUI [2]
C1360419
use of investigational drugs within 30 days of enrollment into study
Description

study drug

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0008972
evidence of de-compensated liver disease including, but not limited to, a history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy.
Description

liver disease decompensated; ascites; hepatic encephalopathy

Data type

boolean

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0205434
UMLS CUI [2]
C0003962
UMLS CUI [3]
C0019151
substance abuse (including but not limited to alcohol abuse, illicit drugs,
Description

Substance Use Disorder

Data type

boolean

Alias
UMLS CUI [1]
C0038586
inhalational drugs, marijuana use, etc) any time prior to entry into the study
Description

Inhalation of Drugs; Marijuana Abuse

Data type

boolean

Alias
UMLS CUI [1]
C0086464
UMLS CUI [2]
C0024809
any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of any drug.
Description

concomitant therapy; drug elimination; drug metabolism

Data type

boolean

Alias
UMLS CUI [1]
C1707479
UMLS CUI [2]
C0683141
UMLS CUI [3]
C0683140
pregnant or breastfeeding female
Description

pregnancy; lactating

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
meeting any of the laboratory exclusion criteria
Description

exclusion criteria

Data type

boolean

Alias
UMLS CUI [1]
C0680251
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Similar models

Eligibility Hepatitis C, Chronic NCT01425190

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
chronic hepatitis c
Item
documented chronic hepatitis c (chc) genotype 1 infection
boolean
C0524910 (UMLS CUI [1])
therapy naive; therapy ribavirin
Item
treatment naïve or failed previous interferon/ribavirin therapy (≥12 uninterrupted weeks)
boolean
C0919936 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0035525 (UMLS CUI [2,2])
weight; screening
Item
weigh between 10 kg to 90 kg inclusive at screening and baseline (day -1).
boolean
C0005910 (UMLS CUI [1])
C0220908 (UMLS CUI [2])
body mass index; center for disease control and prevention
Item
body mass index (bmi) from the 5th to the 95th percentile for the participant's age and gender, inclusive, per tables from the center for disease control and prevention, usa
boolean
C1305855 (UMLS CUI [1])
C0007670 (UMLS CUI [2])
contraception
Item
use of acceptable methods of contraception for at least 3 months prior to baseline and continue on study
boolean
C0700589 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
HBV coinfection; human immunodeficiency virus infection
Item
co-infection with the human immunodeficiency virus (hiv) or hepatitis b virus (hbsag positive).
boolean
C2242656 (UMLS CUI [1])
C0019693 (UMLS CUI [2])
therapy interferon-alfa
Item
treatment with ribavirin within 90 days, or any interferon-alfa within 30 days
boolean
C0087111 (UMLS CUI [1,1])
C0002199 (UMLS CUI [1,2])
adverse events therapy interferon-alfa
Item
discontinued from interferon treatment due to adverse events
boolean
C0877248 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0002199 (UMLS CUI [1,3])
Antiviral Therapy
Item
currently receiving antiviral/immunomodulating therapy for hepatitis c
boolean
C0280274 (UMLS CUI [1])
therapy hcv protease inhibitor
Item
prior treatment with an hcv protease inhibitor
boolean
C0087111 (UMLS CUI [1,1])
C3160091 (UMLS CUI [1,2])
drugs hepatotoxic; Herbal Drugs
Item
prior treatment with any known hepatotoxic agent (including herbal remedies)
boolean
C0013227 (UMLS CUI [1,1])
C0235378 (UMLS CUI [1,2])
C1360419 (UMLS CUI [2])
study drug
Item
use of investigational drugs within 30 days of enrollment into study
boolean
C0013227 (UMLS CUI [1,1])
C0008972 (UMLS CUI [1,2])
liver disease decompensated; ascites; hepatic encephalopathy
Item
evidence of de-compensated liver disease including, but not limited to, a history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy.
boolean
C0023895 (UMLS CUI [1,1])
C0205434 (UMLS CUI [1,2])
C0003962 (UMLS CUI [2])
C0019151 (UMLS CUI [3])
Substance Use Disorder
Item
substance abuse (including but not limited to alcohol abuse, illicit drugs,
boolean
C0038586 (UMLS CUI [1])
Inhalation of Drugs; Marijuana Abuse
Item
inhalational drugs, marijuana use, etc) any time prior to entry into the study
boolean
C0086464 (UMLS CUI [1])
C0024809 (UMLS CUI [2])
concomitant therapy; drug elimination; drug metabolism
Item
any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of any drug.
boolean
C1707479 (UMLS CUI [1])
C0683141 (UMLS CUI [2])
C0683140 (UMLS CUI [3])
pregnancy; lactating
Item
pregnant or breastfeeding female
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
exclusion criteria
Item
meeting any of the laboratory exclusion criteria
boolean
C0680251 (UMLS CUI [1])
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