ID

39684

Beschreibung

Sofosbuvir Plus Ribavirin Administered for Either 12 or 24 Weeks in Treatment-Naive and Treatment-Experienced Egyptian Adults With Chronic Genotype 4 Hepatitis C Virus (HCV) Infection; ODM derived from: https://clinicaltrials.gov/show/NCT01838590

Link

https://clinicaltrials.gov/show/NCT01838590

Stichworte

  1. 10.02.20 10.02.20 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

10. Februar 2020

DOI

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Lizenz

Creative Commons BY 4.0

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Eligibility Hepatitis C Virus NCT01838590

Eligibility Hepatitis C Virus NCT01838590

Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
treatment experienced and naïve subjects
Beschreibung

Therapy Experience | Therapy naive

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0596545
UMLS CUI [2]
C0919936
chronic genotype 4 hcv-infection
Beschreibung

Chronic Hepatitis C Genotype

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0524910
UMLS CUI [1,2]
C1533728
not co-infected with hiv
Beschreibung

HIV coinfection Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C4062778
UMLS CUI [1,2]
C0332197
screening laboratory values within defined thresholds
Beschreibung

Laboratory Results Within Threshold

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C0332285
UMLS CUI [1,3]
C0449864
use of highly effective contraception methods
Beschreibung

Use of Contraceptive methods

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1524063
UMLS CUI [1,2]
C0700589
subject must be able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments.
Beschreibung

Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1]
C0525058
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of any other clinically significant chronic liver disease
Beschreibung

Chronic liver disease Other

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0341439
UMLS CUI [1,2]
C0205394
pregnant or nursing female or male with pregnant female partner
Beschreibung

Pregnancy | Breast Feeding | Gender Partner Pregnancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0682323
UMLS CUI [3,3]
C0032961
history of clinically-significant illness or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol
Beschreibung

Illness Interferes with Therapeutic procedure | Illness Interferes with Assessment | Illness Interferes with Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0087111
UMLS CUI [2,1]
C0221423
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C1516048
UMLS CUI [3,1]
C0221423
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0525058
excessive alcohol ingestion or significant drug abuse
Beschreibung

Alcohol intake above recommended sensible limits | Drug abuse

Datentyp

boolean

Alias
UMLS CUI [1]
C0560219
UMLS CUI [2]
C0013146

Ähnliche Modelle

Eligibility Hepatitis C Virus NCT01838590

Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Therapy Experience | Therapy naive
Item
treatment experienced and naïve subjects
boolean
C0087111 (UMLS CUI [1,1])
C0596545 (UMLS CUI [1,2])
C0919936 (UMLS CUI [2])
Chronic Hepatitis C Genotype
Item
chronic genotype 4 hcv-infection
boolean
C0524910 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
HIV coinfection Absent
Item
not co-infected with hiv
boolean
C4062778 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Laboratory Results Within Threshold
Item
screening laboratory values within defined thresholds
boolean
C1254595 (UMLS CUI [1,1])
C0332285 (UMLS CUI [1,2])
C0449864 (UMLS CUI [1,3])
Use of Contraceptive methods
Item
use of highly effective contraception methods
boolean
C1524063 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Protocol Compliance
Item
subject must be able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments.
boolean
C0525058 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Chronic liver disease Other
Item
history of any other clinically significant chronic liver disease
boolean
C0341439 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Pregnancy | Breast Feeding | Gender Partner Pregnancy
Item
pregnant or nursing female or male with pregnant female partner
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0079399 (UMLS CUI [3,1])
C0682323 (UMLS CUI [3,2])
C0032961 (UMLS CUI [3,3])
Illness Interferes with Therapeutic procedure | Illness Interferes with Assessment | Illness Interferes with Protocol Compliance
Item
history of clinically-significant illness or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol
boolean
C0221423 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0221423 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C1516048 (UMLS CUI [2,3])
C0221423 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0525058 (UMLS CUI [3,3])
Alcohol intake above recommended sensible limits | Drug abuse
Item
excessive alcohol ingestion or significant drug abuse
boolean
C0560219 (UMLS CUI [1])
C0013146 (UMLS CUI [2])

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