ID

27869

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT00983060

Nyckelord

Versioner (1)
  1. 2017-12-03 2017-12-03 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

3 december 2017

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Chronic Hepatitis C Genotype-1 Relapse NCT00983060

Engelsk

Eligibility Chronic Hepatitis C Genotype-1 Relapse NCT00983060

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

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

Criteria Fulfill

Datatyp

boolean

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

Chronic hepatitis C genotype 1

Datatyp

boolean

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

Hepatitis C virus RNA assay

Datatyp

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
Beskrivning

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

Datatyp

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
Beskrivning

Exclusion Criteria

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

Therapeutic procedure Hepatitis C

Datatyp

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
Beskrivning

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

Datatyp

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
Beskrivning

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

Datatyp

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
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

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

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

Datatyp

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
Beskrivning

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

Datatyp

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
Beskrivning

Therapeutic procedure Depressive disorder

Datatyp

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
Beskrivning

Steroids | Immunosuppressive Agents | Clinical Trial Eligibility Criteria Study Protocol

Datatyp

boolean

Alias
UMLS CUI [1]
C0038317
UMLS CUI [2]
C0021081
UMLS CUI [3,1]
C1516637
UMLS CUI [3,2]
C2348563
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Similar models

Eligibility Chronic Hepatitis C Genotype-1 Relapse NCT00983060

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
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