ID

44281

Beschreibung

Safety and Tolerability of Boceprevir in Combination With Peginterferon Alfa-2b Plus Ribavirin for the Treatment of Vietnamese Subjects With Chronic Hepatitis C Genotype 1 (P08599); ODM derived from: https://clinicaltrials.gov/show/NCT01641666

Link

https://clinicaltrials.gov/show/NCT01641666

Stichworte

Versionen (2)
  1. 25.02.19 25.02.19 -
  2. 20.09.21 20.09.21 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

20. September 2021

DOI

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Creative Commons BY 4.0
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Eligibility Chronic Hepatitis C NCT01641666

Englisch

Eligibility Chronic Hepatitis C NCT01641666

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
weight ≥ 40 kg to ≤ 125 kg
Beschreibung

Body Weight

Datentyp

boolean

Alias
UMLS CUI [1]
C0005910
sexually active male participants and female participants of child-bearing potential must agree to use a medically acceptable form of contraception
Beschreibung

Gender Sexually active Contraceptive methods | Childbearing Potential Contraceptive methods

Datentyp

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
must have documented chronic hepatitis c genotype 1 infection
Beschreibung

Chronic Hepatitis C Genotype

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0524910
UMLS CUI [1,2]
C0017431
must have failed prior treatment with interferon plus ribavirin
Beschreibung

Prior Therapy failed | Interferon Plus Ribavirin

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0231175
UMLS CUI [2,1]
C3652465
UMLS CUI [2,2]
C0332287
UMLS CUI [2,3]
C0035525
must have completed treatment with interferon plus ribavirin for at least 12 weeks
Beschreibung

Treatment completed | Interferon Plus Ribavirin

Datentyp

boolean

Alias
UMLS CUI [1]
C0580352
UMLS CUI [2,1]
C3652465
UMLS CUI [2,2]
C0332287
UMLS CUI [2,3]
C0035525
must have had a liver biopsy or fibroscan to determine status as cirrhotic or non-cirrhotic
Beschreibung

Status Cirrhotic Biopsy of liver | Status Non-cirrhotic Biopsy of liver | Status Cirrhotic Fibroscan | Status Non-cirrhotic Fibroscan

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0449438
UMLS CUI [1,2]
C0439686
UMLS CUI [1,3]
C0193388
UMLS CUI [2,1]
C0449438
UMLS CUI [2,2]
C0439687
UMLS CUI [2,3]
C0193388
UMLS CUI [3,1]
C0449438
UMLS CUI [3,2]
C0439686
UMLS CUI [3,3]
C4522043
UMLS CUI [4,1]
C0449438
UMLS CUI [4,2]
C0439687
UMLS CUI [4,3]
C4522043
participants with cirrhosis must have had an ultrasound or imaging study within 6 months of the screening visit
Beschreibung

Liver Cirrhosis Ultrasonography | Liver Cirrhosis Imaging study

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0023890
UMLS CUI [1,2]
C0041618
UMLS CUI [2,1]
C0023890
UMLS CUI [2,2]
C1881134
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
known co-infection with the human immunodeficiency virus (hiv) or the hepatitis b virus
Beschreibung

HIV Coinfection | HBV coinfection

Datentyp

boolean

Alias
UMLS CUI [1]
C4505456
UMLS CUI [2]
C2242656
prior discontinuation of treatment with interferon or ribavirin due to the occurrence of an adverse event(s) considered by the investigator to be possibly or probably related to the treatment
Beschreibung

Treatment Discontinuation Due to Adverse event | Interferon | Ribavirin

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C1444662
UMLS CUI [1,3]
C0678226
UMLS CUI [1,4]
C0877248
UMLS CUI [2]
C3652465
UMLS CUI [3]
C0035525
treatment with ribavirin within 90 days and any interferon within 1 month of the screening visit
Beschreibung

Ribavirin | Interferon

Datentyp

boolean

Alias
UMLS CUI [1]
C0035525
UMLS CUI [2]
C3652465
treatment with any investigational drug within 30 days prior to the screening visit
Beschreibung

Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C0013230
treatment with midazolam, pimozide, amiodarone, flecainide, propafenone, quinidine, or ergot derivatives within 2 weeks prior to the day 1 visit
Beschreibung

Midazolam | Pimozide | Amiodarone | Flecainide | Propafenone | Quinidine | Ergot Derivatives

Datentyp

boolean

Alias
UMLS CUI [1]
C0026056
UMLS CUI [2]
C0031935
UMLS CUI [3]
C0002598
UMLS CUI [4]
C0016229
UMLS CUI [5]
C0033429
UMLS CUI [6]
C0034414
UMLS CUI [7]
C3536994
participation in any investigational trial within 30 days of the screening visit
Beschreibung

Study Subject Participation Status | Clinical Trial Investigational

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0008976
UMLS CUI [2,2]
C1517586
evidence of decompensated liver disease
Beschreibung

Decompensated liver disease

Datentyp

boolean

Alias
UMLS CUI [1]
C4075847
child pugh score > 6 (class b and c)
Beschreibung

Child-Pugh Classification

Datentyp

boolean

Alias
UMLS CUI [1]
C4050412
diabetic and/or hypertensive participants with clinically significant ocular examination findings
Beschreibung

Study Subject Diabetic | Study Subject Hypertensive | Examination finding Ocular Clinical Significance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0241863
UMLS CUI [2,1]
C0681850
UMLS CUI [2,2]
C0857121
UMLS CUI [3,1]
C0438105
UMLS CUI [3,2]
C1299003
UMLS CUI [3,3]
C2826293
pre-existing psychiatric conditions
Beschreibung

Mental condition Pre-existing

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3840291
UMLS CUI [1,2]
C2347662
clinical diagnosis of substance abuse
Beschreibung

Substance Use Disorders

Datentyp

boolean

Alias
UMLS CUI [1]
C0038586
active or suspected malignancy
Beschreibung

Malignant Neoplasms | Malignant Neoplasms Suspected

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C0006826
UMLS CUI [2,2]
C0750491
pregnant or nursing
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Ähnliche Modelle

Eligibility Chronic Hepatitis C NCT01641666

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Body Weight
Item
weight ≥ 40 kg to ≤ 125 kg
boolean
C0005910 (UMLS CUI [1])
Gender Sexually active Contraceptive methods | Childbearing Potential Contraceptive methods
Item
sexually active male participants and female participants of child-bearing potential must agree to use a medically acceptable form 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])
Chronic Hepatitis C Genotype
Item
must have documented chronic hepatitis c genotype 1 infection
boolean
C0524910 (UMLS CUI [1,1])
C0017431 (UMLS CUI [1,2])
Prior Therapy failed | Interferon Plus Ribavirin
Item
must have failed prior treatment with interferon plus ribavirin
boolean
C1514463 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
C3652465 (UMLS CUI [2,1])
C0332287 (UMLS CUI [2,2])
C0035525 (UMLS CUI [2,3])
Treatment completed | Interferon Plus Ribavirin
Item
must have completed treatment with interferon plus ribavirin for at least 12 weeks
boolean
C0580352 (UMLS CUI [1])
C3652465 (UMLS CUI [2,1])
C0332287 (UMLS CUI [2,2])
C0035525 (UMLS CUI [2,3])
Status Cirrhotic Biopsy of liver | Status Non-cirrhotic Biopsy of liver | Status Cirrhotic Fibroscan | Status Non-cirrhotic Fibroscan
Item
must have had a liver biopsy or fibroscan to determine status as cirrhotic or non-cirrhotic
boolean
C0449438 (UMLS CUI [1,1])
C0439686 (UMLS CUI [1,2])
C0193388 (UMLS CUI [1,3])
C0449438 (UMLS CUI [2,1])
C0439687 (UMLS CUI [2,2])
C0193388 (UMLS CUI [2,3])
C0449438 (UMLS CUI [3,1])
C0439686 (UMLS CUI [3,2])
C4522043 (UMLS CUI [3,3])
C0449438 (UMLS CUI [4,1])
C0439687 (UMLS CUI [4,2])
C4522043 (UMLS CUI [4,3])
Liver Cirrhosis Ultrasonography | Liver Cirrhosis Imaging study
Item
participants with cirrhosis must have had an ultrasound or imaging study within 6 months of the screening visit
boolean
C0023890 (UMLS CUI [1,1])
C0041618 (UMLS CUI [1,2])
C0023890 (UMLS CUI [2,1])
C1881134 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
HIV Coinfection | HBV coinfection
Item
known co-infection with the human immunodeficiency virus (hiv) or the hepatitis b virus
boolean
C4505456 (UMLS CUI [1])
C2242656 (UMLS CUI [2])
Treatment Discontinuation Due to Adverse event | Interferon | Ribavirin
Item
prior discontinuation of treatment with interferon or ribavirin due to the occurrence of an adverse event(s) considered by the investigator to be possibly or probably related to the treatment
boolean
C0087111 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C0678226 (UMLS CUI [1,3])
C0877248 (UMLS CUI [1,4])
C3652465 (UMLS CUI [2])
C0035525 (UMLS CUI [3])
Ribavirin | Interferon
Item
treatment with ribavirin within 90 days and any interferon within 1 month of the screening visit
boolean
C0035525 (UMLS CUI [1])
C3652465 (UMLS CUI [2])
Investigational New Drugs
Item
treatment with any investigational drug within 30 days prior to the screening visit
boolean
C0013230 (UMLS CUI [1])
Midazolam | Pimozide | Amiodarone | Flecainide | Propafenone | Quinidine | Ergot Derivatives
Item
treatment with midazolam, pimozide, amiodarone, flecainide, propafenone, quinidine, or ergot derivatives within 2 weeks prior to the day 1 visit
boolean
C0026056 (UMLS CUI [1])
C0031935 (UMLS CUI [2])
C0002598 (UMLS CUI [3])
C0016229 (UMLS CUI [4])
C0033429 (UMLS CUI [5])
C0034414 (UMLS CUI [6])
C3536994 (UMLS CUI [7])
Study Subject Participation Status | Clinical Trial Investigational
Item
participation in any investigational trial within 30 days of the screening visit
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2,1])
C1517586 (UMLS CUI [2,2])
Decompensated liver disease
Item
evidence of decompensated liver disease
boolean
C4075847 (UMLS CUI [1])
Child-Pugh Classification
Item
child pugh score > 6 (class b and c)
boolean
C4050412 (UMLS CUI [1])
Study Subject Diabetic | Study Subject Hypertensive | Examination finding Ocular Clinical Significance
Item
diabetic and/or hypertensive participants with clinically significant ocular examination findings
boolean
C0681850 (UMLS CUI [1,1])
C0241863 (UMLS CUI [1,2])
C0681850 (UMLS CUI [2,1])
C0857121 (UMLS CUI [2,2])
C0438105 (UMLS CUI [3,1])
C1299003 (UMLS CUI [3,2])
C2826293 (UMLS CUI [3,3])
Mental condition Pre-existing
Item
pre-existing psychiatric conditions
boolean
C3840291 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
Substance Use Disorders
Item
clinical diagnosis of substance abuse
boolean
C0038586 (UMLS CUI [1])
Malignant Neoplasms | Malignant Neoplasms Suspected
Item
active or suspected malignancy
boolean
C0006826 (UMLS CUI [1])
C0006826 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
Pregnancy | Breast Feeding
Item
pregnant or nursing
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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