ID

39330

Description

Boceprevir With Peginterferon Alfa-2b and Ribavirin in the Treatment-naive Patients Infected With Genotype 4 Chronic Hepatitis C Infection; ODM derived from: https://clinicaltrials.gov/show/NCT01653236

Link

https://clinicaltrials.gov/show/NCT01653236

Keywords

Versions (1)
  1. 12/20/19 12/20/19 -
Copyright Holder

See clinicaltrials.gov

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December 20, 2019

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License

Creative Commons BY 4.0
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Eligibility Genotype 4 Chronic Hepatitis C Infection NCT01653236

English

Eligibility Genotype 4 Chronic Hepatitis C Infection NCT01653236

1 forms  
Criteria
Description

Criteria

genders eligible for study: both
Description

Gender

Data type

boolean

Alias
UMLS CUI [1]
C0079399
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
subject must be more than 18 years of age.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
subject's weight must be more than 40 kg and less than 125 kg.
Description

Body Weight

Data type

boolean

Alias
UMLS CUI [1]
C0005910
subject and subject's partner must each agree to use acceptable methods of contraception for at least 2 weeks prior to day 1 and continue until at least 6 months after last dose of study medication, or longer if dictated by local regulations.
Description

Study Subject Contraceptive methods | Partner Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C0682323
UMLS CUI [2,2]
C0700589
subjects must be willing to give written informed consent for the trial and for the pharmacogenetic testing.
Description

Informed Consent | Informed Consent Pharmacogenetic Test

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C2347500
subjects who are unwilling to provide written informed consent for pharmacogenetic testing may be included in the trial; however, pharmacogenetic samples must not be obtained.
Description

Informed Consent Unwilling Pharmacogenetic Test

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0558080
UMLS CUI [1,3]
C2347500
subject must have previously documented chc genotype 4 infection.
Description

Chronic Hepatitis C Genotype determination

Data type

boolean

Alias
UMLS CUI [1,1]
C0524910
UMLS CUI [1,2]
C1285573
subjects with other or mixed genotypes are not eligible. the hcv-rna result obtained from the central laboratory at the screening visit must confirm genotype 4 infection and be more10,000 iu per ml previously untreated patients with pegylated interferon
Description

Genotype Mixed Ineligible | Genotype Infection Confirmed by Hepatitis C virus RNA | Hepatitis C virus RNA IU/mL | PEGINTERFERON Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0017431
UMLS CUI [1,2]
C0205430
UMLS CUI [1,3]
C1512714
UMLS CUI [2,1]
C0017431
UMLS CUI [2,2]
C3714514
UMLS CUI [2,3]
C0521093
UMLS CUI [2,4]
C0369335
UMLS CUI [3,1]
C0369335
UMLS CUI [3,2]
C0439458
UMLS CUI [4,1]
C0982327
UMLS CUI [4,2]
C0332197
subject must have a liver biopsy or fibrotest and fibroscan with histology consistent with chc and no other etiology.
Description

Biopsy of liver Consistent with Chronic Hepatitis C | FibroTest Consistent with Chronic Hepatitis C | Fibroscan Consistent with Chronic Hepatitis C

Data type

boolean

Alias
UMLS CUI [1,1]
C0193388
UMLS CUI [1,2]
C0332290
UMLS CUI [1,3]
C0524910
UMLS CUI [2,1]
C3642160
UMLS CUI [2,2]
C0332290
UMLS CUI [2,3]
C0524910
UMLS CUI [3,1]
C4522043
UMLS CUI [3,2]
C0332290
UMLS CUI [3,3]
C0524910
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
subject who is coinfected with the human immunodeficiency virus (hiv) or hepatitis b virus.
Description

HIV coinfection | HBV coinfection

Data type

boolean

Alias
UMLS CUI [1]
C4062778
UMLS CUI [2]
C2242656
prior treatment with interferon, ribavirin and/or investigational agent for hepatitis c.
Description

Prior interferon therapy Hepatitis C | Ribavirin Hepatitis C | Investigational New Drugs Hepatitis C

Data type

boolean

Alias
UMLS CUI [1,1]
C0278953
UMLS CUI [1,2]
C0019196
UMLS CUI [2,1]
C0035525
UMLS CUI [2,2]
C0019196
UMLS CUI [3,1]
C0013230
UMLS CUI [3,2]
C0019196
prior treatments with herbal remedies with known hepatotoxicity are exclusionary.
Description

Herbal Drugs Associated with Hepatotoxicity

Data type

boolean

Alias
UMLS CUI [1,1]
C1360419
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C0235378
all herbal remedies used for hepatitis c treatment must be discontinued before day 1.
Description

Herbal Drugs Hepatitis C | Herbal Drugs To be stopped

Data type

boolean

Alias
UMLS CUI [1,1]
C1360419
UMLS CUI [1,2]
C0019196
UMLS CUI [2,1]
C1360419
UMLS CUI [2,2]
C1272691
treatment with any investigational drug within 30 days of the screening visit in this trial.
Description

Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013230
subject who received any of the following medication(s) within 2 weeks prior to the day 1 visit that are highly dependent on cyp3a4.5 for clearance, and for which elevated plasma concentrations are associated with serious and or life-threatening events such as: orally administered midazolam, pimozide, amiodarone, flecainide, propafenone, quinidine and ergot derivatives (dihydroergotamine, ergonovine, ergotamine, methylergonovine).
Description

Midazolam Oral | Pimozide | Amiodarone | Flecainide | Propafenone | Quinidine | Ergot Derivatives | Dihydroergotamine | Ergonovine | Ergotamine | Methylergonovine

Data type

boolean

Alias
UMLS CUI [1,1]
C0026056
UMLS CUI [1,2]
C1527415
UMLS CUI [2]
C0031935
UMLS CUI [3]
C0002598
UMLS CUI [4]
C0016229
UMLS CUI [5]
C0033429
UMLS CUI [6]
C0034414
UMLS CUI [7]
C3536994
UMLS CUI [8]
C0012291
UMLS CUI [9]
C0014704
UMLS CUI [10]
C0014710
UMLS CUI [11]
C0025760
evidence of decompensated liver disease including, but not limited to, a history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy.
Description

End Stage Liver Disease | Ascites | Bleeding varices | Hepatic Encephalopathy

Data type

boolean

Alias
UMLS CUI [1]
C0745744
UMLS CUI [2]
C0003962
UMLS CUI [3]
C0333106
UMLS CUI [4]
C0019151
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Similar models

Eligibility Genotype 4 Chronic Hepatitis C Infection NCT01653236

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Gender
Item
genders eligible for study: both
boolean
C0079399 (UMLS CUI [1])
Item Group
C1512693 (UMLS CUI)
Age
Item
subject must be more than 18 years of age.
boolean
C0001779 (UMLS CUI [1])
Body Weight
Item
subject's weight must be more than 40 kg and less than 125 kg.
boolean
C0005910 (UMLS CUI [1])
Study Subject Contraceptive methods | Partner Contraceptive methods
Item
subject and subject's partner must each agree to use acceptable methods of contraception for at least 2 weeks prior to day 1 and continue until at least 6 months after last dose of study medication, or longer if dictated by local regulations.
boolean
C0681850 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0682323 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Informed Consent | Informed Consent Pharmacogenetic Test
Item
subjects must be willing to give written informed consent for the trial and for the pharmacogenetic testing.
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C2347500 (UMLS CUI [2,2])
Informed Consent Unwilling Pharmacogenetic Test
Item
subjects who are unwilling to provide written informed consent for pharmacogenetic testing may be included in the trial; however, pharmacogenetic samples must not be obtained.
boolean
C0021430 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C2347500 (UMLS CUI [1,3])
Chronic Hepatitis C Genotype determination
Item
subject must have previously documented chc genotype 4 infection.
boolean
C0524910 (UMLS CUI [1,1])
C1285573 (UMLS CUI [1,2])
Genotype Mixed Ineligible | Genotype Infection Confirmed by Hepatitis C virus RNA | Hepatitis C virus RNA IU/mL | PEGINTERFERON Absent
Item
subjects with other or mixed genotypes are not eligible. the hcv-rna result obtained from the central laboratory at the screening visit must confirm genotype 4 infection and be more10,000 iu per ml previously untreated patients with pegylated interferon
boolean
C0017431 (UMLS CUI [1,1])
C0205430 (UMLS CUI [1,2])
C1512714 (UMLS CUI [1,3])
C0017431 (UMLS CUI [2,1])
C3714514 (UMLS CUI [2,2])
C0521093 (UMLS CUI [2,3])
C0369335 (UMLS CUI [2,4])
C0369335 (UMLS CUI [3,1])
C0439458 (UMLS CUI [3,2])
C0982327 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Biopsy of liver Consistent with Chronic Hepatitis C | FibroTest Consistent with Chronic Hepatitis C | Fibroscan Consistent with Chronic Hepatitis C
Item
subject must have a liver biopsy or fibrotest and fibroscan with histology consistent with chc and no other etiology.
boolean
C0193388 (UMLS CUI [1,1])
C0332290 (UMLS CUI [1,2])
C0524910 (UMLS CUI [1,3])
C3642160 (UMLS CUI [2,1])
C0332290 (UMLS CUI [2,2])
C0524910 (UMLS CUI [2,3])
C4522043 (UMLS CUI [3,1])
C0332290 (UMLS CUI [3,2])
C0524910 (UMLS CUI [3,3])
Item Group
C0680251 (UMLS CUI)
HIV coinfection | HBV coinfection
Item
subject who is coinfected with the human immunodeficiency virus (hiv) or hepatitis b virus.
boolean
C4062778 (UMLS CUI [1])
C2242656 (UMLS CUI [2])
Prior interferon therapy Hepatitis C | Ribavirin Hepatitis C | Investigational New Drugs Hepatitis C
Item
prior treatment with interferon, ribavirin and/or investigational agent for hepatitis c.
boolean
C0278953 (UMLS CUI [1,1])
C0019196 (UMLS CUI [1,2])
C0035525 (UMLS CUI [2,1])
C0019196 (UMLS CUI [2,2])
C0013230 (UMLS CUI [3,1])
C0019196 (UMLS CUI [3,2])
Herbal Drugs Associated with Hepatotoxicity
Item
prior treatments with herbal remedies with known hepatotoxicity are exclusionary.
boolean
C1360419 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0235378 (UMLS CUI [1,3])
Herbal Drugs Hepatitis C | Herbal Drugs To be stopped
Item
all herbal remedies used for hepatitis c treatment must be discontinued before day 1.
boolean
C1360419 (UMLS CUI [1,1])
C0019196 (UMLS CUI [1,2])
C1360419 (UMLS CUI [2,1])
C1272691 (UMLS CUI [2,2])
Investigational New Drugs
Item
treatment with any investigational drug within 30 days of the screening visit in this trial.
boolean
C0013230 (UMLS CUI [1])
Midazolam Oral | Pimozide | Amiodarone | Flecainide | Propafenone | Quinidine | Ergot Derivatives | Dihydroergotamine | Ergonovine | Ergotamine | Methylergonovine
Item
subject who received any of the following medication(s) within 2 weeks prior to the day 1 visit that are highly dependent on cyp3a4.5 for clearance, and for which elevated plasma concentrations are associated with serious and or life-threatening events such as: orally administered midazolam, pimozide, amiodarone, flecainide, propafenone, quinidine and ergot derivatives (dihydroergotamine, ergonovine, ergotamine, methylergonovine).
boolean
C0026056 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0031935 (UMLS CUI [2])
C0002598 (UMLS CUI [3])
C0016229 (UMLS CUI [4])
C0033429 (UMLS CUI [5])
C0034414 (UMLS CUI [6])
C3536994 (UMLS CUI [7])
C0012291 (UMLS CUI [8])
C0014704 (UMLS CUI [9])
C0014710 (UMLS CUI [10])
C0025760 (UMLS CUI [11])
End Stage 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
C0745744 (UMLS CUI [1])
C0003962 (UMLS CUI [2])
C0333106 (UMLS CUI [3])
C0019151 (UMLS CUI [4])
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