ID

29696

Beskrivning

An Exploratory Study of Telaprevir in Treatment-Naive Participants With Chronic Genotype 4 Hepatitis C Virus Infection; ODM derived from: https://clinicaltrials.gov/show/NCT00580801

Länk

https://clinicaltrials.gov/show/NCT00580801

Nyckelord

Versioner (1)
  1. 2018-04-13 2018-04-13 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

13 april 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Hepatitis C NCT00580801

Engelsk

Eligibility Hepatitis C NCT00580801

1 Formulär  
Criteria
Beskrivning

Criteria

plasma hepatitis c virus (hcv) ribonucleic acid (rna) level greater than 10,000 international unit per milliliter (iu/ml) at screening
Beskrivning

Plasma Hepatitis C virus RNA IU/mL

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0032105
UMLS CUI [1,2]
C0369335
UMLS CUI [1,3]
C0439458
participant never received treatment for hcv
Beskrivning

Absence Therapeutic procedure Hepatitis C virus

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0220847
participant was to be in good health (besides hcv infection), in the opinion of the investigator, judged on the basis of medical history and physical examination (including vital signs and screening electrocardiogram [ecg]), with any chronic medical conditions under stable medical control
Beskrivning

Good health | Exception Hepatitis C | Medical History | Physical Examination | Vital signs | Electrocardiography | Medical condition chronic Under control

Datatyp

boolean

Alias
UMLS CUI [1]
C3813622
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0019196
UMLS CUI [3]
C0262926
UMLS CUI [4]
C0031809
UMLS CUI [5]
C0518766
UMLS CUI [6]
C1623258
UMLS CUI [7,1]
C3843040
UMLS CUI [7,2]
C0205191
UMLS CUI [7,3]
C2911690
participant had to be willing to refrain from the concomitant use of any medications or substances exclusion criteria: - participants with history or evidence of cirrhosis or history of suspicion of alcohol, barbiturate, or amphetamine recreational or narcotic drug use, which in the investigator's opinion would compromise the participant's safety and/or compliance with study procedures
Beskrivning

Avoidance Concomitant Agent | Exclusion Criteria | Liver Cirrhosis | Alcohol consumption compromises Patient safety | Barbiturates compromise Patient safety | Amphetamine compromises Patient safety | Narcotic Drugs compromise Patient safety | Alcohol consumption compromises Protocol Compliance | Barbiturates compromise Protocol Compliance | Amphetamine compromises Protocol Compliance | Narcotic Drugs compromise Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0870186
UMLS CUI [1,2]
C2347852
UMLS CUI [2]
C0680251
UMLS CUI [3]
C0023890
UMLS CUI [4,1]
C0001948
UMLS CUI [4,2]
C2945640
UMLS CUI [4,3]
C1113679
UMLS CUI [5,1]
C0004745
UMLS CUI [5,2]
C2945640
UMLS CUI [5,3]
C1113679
UMLS CUI [6,1]
C0002658
UMLS CUI [6,2]
C2945640
UMLS CUI [6,3]
C1113679
UMLS CUI [7,1]
C0237425
UMLS CUI [7,2]
C2945640
UMLS CUI [7,3]
C1113679
UMLS CUI [8,1]
C0001948
UMLS CUI [8,2]
C2945640
UMLS CUI [8,3]
C0525058
UMLS CUI [9,1]
C0004745
UMLS CUI [9,2]
C2945640
UMLS CUI [9,3]
C0525058
UMLS CUI [10,1]
C0002658
UMLS CUI [10,2]
C2945640
UMLS CUI [10,3]
C0525058
UMLS CUI [11,1]
C0237425
UMLS CUI [11,2]
C2945640
UMLS CUI [11,3]
C0525058
participant has human immunodeficiency virus (hiv) or hepatitis b virus (hbv) co-infection
Beskrivning

HIV coinfection | HBV coinfection

Datatyp

boolean

Alias
UMLS CUI [1]
C4062778
UMLS CUI [2]
C2242656
female participants who are pregnant, or planning to become pregnant, or breastfeeding, and partners of female participants who are pregnant or breastfeeding
Beskrivning

Pregnancy | Pregnancy, Planned | Breast Feeding | Partner Study participant Pregnancy | Partner Study participant Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
UMLS CUI [3]
C0006147
UMLS CUI [4,1]
C0682323
UMLS CUI [4,2]
C0681850
UMLS CUI [4,3]
C0032961
UMLS CUI [5,1]
C0682323
UMLS CUI [5,2]
C0681850
UMLS CUI [5,3]
C0006147
participant has hypersensitivity to tartrazine
Beskrivning

Hypersensitivity Tartrazine

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0039329
participant had participated in any clinical trial for an investigational drug within 90 days before drug administration or participated in more than 2 drug studies in the last 12 months
Beskrivning

Study Subject Participation Status | Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
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Similar models

Eligibility Hepatitis C NCT00580801

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Plasma Hepatitis C virus RNA IU/mL
Item
plasma hepatitis c virus (hcv) ribonucleic acid (rna) level greater than 10,000 international unit per milliliter (iu/ml) at screening
boolean
C0032105 (UMLS CUI [1,1])
C0369335 (UMLS CUI [1,2])
C0439458 (UMLS CUI [1,3])
Absence Therapeutic procedure Hepatitis C virus
Item
participant never received treatment for hcv
boolean
C0332197 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0220847 (UMLS CUI [1,3])
Good health | Exception Hepatitis C | Medical History | Physical Examination | Vital signs | Electrocardiography | Medical condition chronic Under control
Item
participant was to be in good health (besides hcv infection), in the opinion of the investigator, judged on the basis of medical history and physical examination (including vital signs and screening electrocardiogram [ecg]), with any chronic medical conditions under stable medical control
boolean
C3813622 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0019196 (UMLS CUI [2,2])
C0262926 (UMLS CUI [3])
C0031809 (UMLS CUI [4])
C0518766 (UMLS CUI [5])
C1623258 (UMLS CUI [6])
C3843040 (UMLS CUI [7,1])
C0205191 (UMLS CUI [7,2])
C2911690 (UMLS CUI [7,3])
Avoidance Concomitant Agent | Exclusion Criteria | Liver Cirrhosis | Alcohol consumption compromises Patient safety | Barbiturates compromise Patient safety | Amphetamine compromises Patient safety | Narcotic Drugs compromise Patient safety | Alcohol consumption compromises Protocol Compliance | Barbiturates compromise Protocol Compliance | Amphetamine compromises Protocol Compliance | Narcotic Drugs compromise Protocol Compliance
Item
participant had to be willing to refrain from the concomitant use of any medications or substances exclusion criteria: - participants with history or evidence of cirrhosis or history of suspicion of alcohol, barbiturate, or amphetamine recreational or narcotic drug use, which in the investigator's opinion would compromise the participant's safety and/or compliance with study procedures
boolean
C0870186 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0680251 (UMLS CUI [2])
C0023890 (UMLS CUI [3])
C0001948 (UMLS CUI [4,1])
C2945640 (UMLS CUI [4,2])
C1113679 (UMLS CUI [4,3])
C0004745 (UMLS CUI [5,1])
C2945640 (UMLS CUI [5,2])
C1113679 (UMLS CUI [5,3])
C0002658 (UMLS CUI [6,1])
C2945640 (UMLS CUI [6,2])
C1113679 (UMLS CUI [6,3])
C0237425 (UMLS CUI [7,1])
C2945640 (UMLS CUI [7,2])
C1113679 (UMLS CUI [7,3])
C0001948 (UMLS CUI [8,1])
C2945640 (UMLS CUI [8,2])
C0525058 (UMLS CUI [8,3])
C0004745 (UMLS CUI [9,1])
C2945640 (UMLS CUI [9,2])
C0525058 (UMLS CUI [9,3])
C0002658 (UMLS CUI [10,1])
C2945640 (UMLS CUI [10,2])
C0525058 (UMLS CUI [10,3])
C0237425 (UMLS CUI [11,1])
C2945640 (UMLS CUI [11,2])
C0525058 (UMLS CUI [11,3])
HIV coinfection | HBV coinfection
Item
participant has human immunodeficiency virus (hiv) or hepatitis b virus (hbv) co-infection
boolean
C4062778 (UMLS CUI [1])
C2242656 (UMLS CUI [2])
Pregnancy | Pregnancy, Planned | Breast Feeding | Partner Study participant Pregnancy | Partner Study participant Breast Feeding
Item
female participants who are pregnant, or planning to become pregnant, or breastfeeding, and partners of female participants who are pregnant or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
C0682323 (UMLS CUI [4,1])
C0681850 (UMLS CUI [4,2])
C0032961 (UMLS CUI [4,3])
C0682323 (UMLS CUI [5,1])
C0681850 (UMLS CUI [5,2])
C0006147 (UMLS CUI [5,3])
Hypersensitivity Tartrazine
Item
participant has hypersensitivity to tartrazine
boolean
C0020517 (UMLS CUI [1,1])
C0039329 (UMLS CUI [1,2])
Study Subject Participation Status | Investigational New Drugs
Item
participant had participated in any clinical trial for an investigational drug within 90 days before drug administration or participated in more than 2 drug studies in the last 12 months
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
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