ID

27869

Descripción

Adaptive-design Dose Finding Study to Assess the Antiviral Efficacy and Safety of NIM811 Administered in Combination With Standard of Care (SOC) in Relapsed Hepatitis C Virus 1 (HCV-1) Infected Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00983060

Link

https://clinicaltrials.gov/show/NCT00983060

Palabras clave

Versiones (1)
  1. 3/12/17 3/12/17 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

3 de diciembre de 2017

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY 4.0
Comentarios del modelo :

Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.

Volver a los comentarios del modelo
Comentarios de grupo de elementos para :

Comentarios del elemento para :

Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.

Eligibility Chronic Hepatitis C Genotype-1 Relapse NCT00983060

Inglés

Eligibility Chronic Hepatitis C Genotype-1 Relapse NCT00983060

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients eligible for inclusion in this study have to fulfill all of the following criteria:
Descripción

Criteria Fulfill

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
chronic hepatitis c genotype-1
Descripción

Chronic hepatitis C genotype 1

Tipo de datos

boolean

Alias
UMLS CUI [1]
C4049392
hcv-rna should be ≥ 4 x 105 iu/ml at screening
Descripción

Hepatitis C virus RNA assay

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1272251
recipient of prior long acting interferon and ribavirin treatment for at least 12 weeks, with documented negative serum hcv rna on treatment, who subsequently becomes serum hcv rna positive after stopping treatment ("relapser"). patients must have been off all treatment for at least 3 months prior to start of study (visit
Descripción

Interferon Long-term Active | Ribavirin Long-term Active | Hepatitis C RNA negative | Relapse | Hepatitis C RNA positive Post Therapeutic procedure Discontinued | Therapeutic procedure To be stopped

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0021747
UMLS CUI [1,2]
C0443252
UMLS CUI [1,3]
C0205177
UMLS CUI [2,1]
C0035525
UMLS CUI [2,2]
C0443252
UMLS CUI [2,3]
C0205177
UMLS CUI [3]
C0855841
UMLS CUI [4]
C0035020
UMLS CUI [5,1]
C0855842
UMLS CUI [5,2]
C0687676
UMLS CUI [5,3]
C0087111
UMLS CUI [5,4]
C1444662
UMLS CUI [6,1]
C0087111
UMLS CUI [6,2]
C1272691
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
use of any hcv treatment ≤ 3months prior to study start
Descripción

Therapeutic procedure Hepatitis C

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0019196
prior receipt of any investigational anti-hcv therapy which is not ifn or rbv
Descripción

Investigational Therapy Against Hepatitis C virus | Exception Interferon | Exception Ribavirin

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0949266
UMLS CUI [1,2]
C0521124
UMLS CUI [1,3]
C0220847
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0021747
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0035525
women of child-bearing potential unless they are post-menopausal or use predefined acceptable methods of contraception
Descripción

Childbearing Potential | Exception Postmenopausal state | Exception Contraceptive methods Use of

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3831118
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0232970
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C1524063
pregnant or breastfeeding women
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
evidence of cirrhosis, hepatic decompensation, other than hcv liver disease, hbv or hiv infection
Descripción

Liver Cirrhosis | Hepatic decompensation | Exception Hepatitis C | Exception Hepatitis B | Exception HIV Infection

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023890
UMLS CUI [2]
C1394798
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0019196
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0019163
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0019693
specified abnormalities in lab values of amongst others hemoglobin, wbc, anc, platelets
Descripción

Laboratory test result abnormal Specified | Abnormal Hemoglobin | White blood cell abnormality | Absolute neutrophil count abnormal | Abnormal platelets

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0438215
UMLS CUI [1,2]
C0205369
UMLS CUI [2]
C0019047
UMLS CUI [3]
C0152009
UMLS CUI [4]
C1262264
UMLS CUI [5]
C0151854
history of treatment for depression
Descripción

Therapeutic procedure Depressive disorder

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0011581
steroid/immunosuppression drug use 3 months prior to study start other protocol-defined inclusion/exclusion criteria may apply
Descripción

Steroids | Immunosuppressive Agents | Clinical Trial Eligibility Criteria Study Protocol

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0038317
UMLS CUI [2]
C0021081
UMLS CUI [3,1]
C1516637
UMLS CUI [3,2]
C2348563
Volver a la parte superior de la página

Similar models

Eligibility Chronic Hepatitis C Genotype-1 Relapse NCT00983060

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Criteria Fulfill
Item
patients eligible for inclusion in this study have to fulfill all of the following criteria:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Chronic hepatitis C genotype 1
Item
chronic hepatitis c genotype-1
boolean
C4049392 (UMLS CUI [1])
Hepatitis C virus RNA assay
Item
hcv-rna should be ≥ 4 x 105 iu/ml at screening
boolean
C1272251 (UMLS CUI [1])
Interferon Long-term Active | Ribavirin Long-term Active | Hepatitis C RNA negative | Relapse | Hepatitis C RNA positive Post Therapeutic procedure Discontinued | Therapeutic procedure To be stopped
Item
recipient of prior long acting interferon and ribavirin treatment for at least 12 weeks, with documented negative serum hcv rna on treatment, who subsequently becomes serum hcv rna positive after stopping treatment ("relapser"). patients must have been off all treatment for at least 3 months prior to start of study (visit
boolean
C0021747 (UMLS CUI [1,1])
C0443252 (UMLS CUI [1,2])
C0205177 (UMLS CUI [1,3])
C0035525 (UMLS CUI [2,1])
C0443252 (UMLS CUI [2,2])
C0205177 (UMLS CUI [2,3])
C0855841 (UMLS CUI [3])
C0035020 (UMLS CUI [4])
C0855842 (UMLS CUI [5,1])
C0687676 (UMLS CUI [5,2])
C0087111 (UMLS CUI [5,3])
C1444662 (UMLS CUI [5,4])
C0087111 (UMLS CUI [6,1])
C1272691 (UMLS CUI [6,2])
Item Group
C0680251 (UMLS CUI)
Therapeutic procedure Hepatitis C
Item
use of any hcv treatment ≤ 3months prior to study start
boolean
C0087111 (UMLS CUI [1,1])
C0019196 (UMLS CUI [1,2])
Investigational Therapy Against Hepatitis C virus | Exception Interferon | Exception Ribavirin
Item
prior receipt of any investigational anti-hcv therapy which is not ifn or rbv
boolean
C0949266 (UMLS CUI [1,1])
C0521124 (UMLS CUI [1,2])
C0220847 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0021747 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0035525 (UMLS CUI [3,2])
Childbearing Potential | Exception Postmenopausal state | Exception Contraceptive methods Use of
Item
women of child-bearing potential unless they are post-menopausal or use predefined acceptable methods of contraception
boolean
C3831118 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0232970 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C1524063 (UMLS CUI [3,3])
Pregnancy | Breast Feeding
Item
pregnant or breastfeeding women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Liver Cirrhosis | Hepatic decompensation | Exception Hepatitis C | Exception Hepatitis B | Exception HIV Infection
Item
evidence of cirrhosis, hepatic decompensation, other than hcv liver disease, hbv or hiv infection
boolean
C0023890 (UMLS CUI [1])
C1394798 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0019196 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0019163 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0019693 (UMLS CUI [5,2])
Laboratory test result abnormal Specified | Abnormal Hemoglobin | White blood cell abnormality | Absolute neutrophil count abnormal | Abnormal platelets
Item
specified abnormalities in lab values of amongst others hemoglobin, wbc, anc, platelets
boolean
C0438215 (UMLS CUI [1,1])
C0205369 (UMLS CUI [1,2])
C0019047 (UMLS CUI [2])
C0152009 (UMLS CUI [3])
C1262264 (UMLS CUI [4])
C0151854 (UMLS CUI [5])
Therapeutic procedure Depressive disorder
Item
history of treatment for depression
boolean
C0087111 (UMLS CUI [1,1])
C0011581 (UMLS CUI [1,2])
Steroids | Immunosuppressive Agents | Clinical Trial Eligibility Criteria Study Protocol
Item
steroid/immunosuppression drug use 3 months prior to study start other protocol-defined inclusion/exclusion criteria may apply
boolean
C0038317 (UMLS CUI [1])
C0021081 (UMLS CUI [2])
C1516637 (UMLS CUI [3,1])
C2348563 (UMLS CUI [3,2])
Volver a la parte superior de la página 

Contacto

Utilice este formulario para comentarios, preguntas y sugerencias.

Los campos marcados con * son obligatorios.

Ayuda

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial