ID

29740

Descripción

Effect of Insulin Resistance on the Safety and Efficacy of Pegylated Interferon and Ribavirin Treatment in HCV (Study P05562); ODM derived from: https://clinicaltrials.gov/show/NCT00705224

Link

https://clinicaltrials.gov/show/NCT00705224

Palabras clave

Versiones (1)
  1. 17/4/18 17/4/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

17 de abril de 2018

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Hepatitis C, Chronic NCT00705224

Inglés

Eligibility Hepatitis C, Chronic NCT00705224

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
confirmed diagnosis of chc according to local regulations
Descripción

Hepatitis C, Chronic

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0524910
naïve pegylated interferon (peg-ifn) chc patient
Descripción

Peginterferon naive Chronic Hepatitis C

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0982327
UMLS CUI [1,2]
C0919936
UMLS CUI [1,3]
C0524910
no contraindications for peg-ifn chc therapy
Descripción

Absence Medical contraindication Peginterferon Chronic Hepatitis C

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C1301624
UMLS CUI [1,3]
C0982327
UMLS CUI [1,4]
C0524910
negative urine pregnancy test result (for females of childbearing potential) documented within the 24-hour period prior to the first dose of study drugs. additionally, all female patients of childbearing potential and all males with female partners of childbearing potential must use two forms of effective contraception (combined) during treatment and 6 months after treatment end
Descripción

Childbearing Potential Urine pregnancy test negative | Childbearing Potential Contraceptive methods Quantity | Gender Partner Childbearing Potential Contraceptive methods Quantity

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430057
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C1265611
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0682323
UMLS CUI [3,3]
C3831118
UMLS CUI [3,4]
C0700589
UMLS CUI [3,5]
C1265611
willingness to give written informed consent and willingness to participate in and comply with the study requirements.
Descripción

Informed Consent | Protocol Compliance

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C0525058
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
peg-ifn treatment in history
Descripción

Peginterferon History

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0982327
UMLS CUI [1,2]
C0019665
contraindications for peg-ifn chc therapy
Descripción

Medical contraindication Peginterferon Chronic Hepatitis C

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0982327
UMLS CUI [1,3]
C0524910
females who are pregnant or breast-feeding
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
male partners of females who are pregnant
Descripción

Gender Partner Pregnancy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0682323
UMLS CUI [1,3]
C0032961
potentially unreliable participants, and those judged by the investigator to be unsuitable for the study.
Descripción

Study Subject Unreliable | Study Subject Participation Status Inappropriate

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C4061925
UMLS CUI [2,1]
C2348568
UMLS CUI [2,2]
C1548788
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Similar models

Eligibility Hepatitis C, Chronic NCT00705224

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Hepatitis C, Chronic
Item
confirmed diagnosis of chc according to local regulations
boolean
C0524910 (UMLS CUI [1])
Peginterferon naive Chronic Hepatitis C
Item
naïve pegylated interferon (peg-ifn) chc patient
boolean
C0982327 (UMLS CUI [1,1])
C0919936 (UMLS CUI [1,2])
C0524910 (UMLS CUI [1,3])
Absence Medical contraindication Peginterferon Chronic Hepatitis C
Item
no contraindications for peg-ifn chc therapy
boolean
C0332197 (UMLS CUI [1,1])
C1301624 (UMLS CUI [1,2])
C0982327 (UMLS CUI [1,3])
C0524910 (UMLS CUI [1,4])
Childbearing Potential Urine pregnancy test negative | Childbearing Potential Contraceptive methods Quantity | Gender Partner Childbearing Potential Contraceptive methods Quantity
Item
negative urine pregnancy test result (for females of childbearing potential) documented within the 24-hour period prior to the first dose of study drugs. additionally, all female patients of childbearing potential and all males with female partners of childbearing potential must use two forms of effective contraception (combined) during treatment and 6 months after treatment end
boolean
C3831118 (UMLS CUI [1,1])
C0430057 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0079399 (UMLS CUI [3,1])
C0682323 (UMLS CUI [3,2])
C3831118 (UMLS CUI [3,3])
C0700589 (UMLS CUI [3,4])
C1265611 (UMLS CUI [3,5])
Informed Consent | Protocol Compliance
Item
willingness to give written informed consent and willingness to participate in and comply with the study requirements.
boolean
C0021430 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Peginterferon History
Item
peg-ifn treatment in history
boolean
C0982327 (UMLS CUI [1,1])
C0019665 (UMLS CUI [1,2])
Medical contraindication Peginterferon Chronic Hepatitis C
Item
contraindications for peg-ifn chc therapy
boolean
C1301624 (UMLS CUI [1,1])
C0982327 (UMLS CUI [1,2])
C0524910 (UMLS CUI [1,3])
Pregnancy | Breast Feeding
Item
females who are pregnant or breast-feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Gender Partner Pregnancy
Item
male partners of females who are pregnant
boolean
C0079399 (UMLS CUI [1,1])
C0682323 (UMLS CUI [1,2])
C0032961 (UMLS CUI [1,3])
Study Subject Unreliable | Study Subject Participation Status Inappropriate
Item
potentially unreliable participants, and those judged by the investigator to be unsuitable for the study.
boolean
C0681850 (UMLS CUI [1,1])
C4061925 (UMLS CUI [1,2])
C2348568 (UMLS CUI [2,1])
C1548788 (UMLS CUI [2,2])
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