ID

39729

Beskrivning

A Study to Evaluate the Safety and Effect of Co-administration of ABT-450 With Ritonavir (ABT-450/r) and ABT-267 in Adults With Chronic Hepatitis C Virus Infection; ODM derived from: https://clinicaltrials.gov/show/NCT01685203

Länk

https://clinicaltrials.gov/show/NCT01685203

Nyckelord

Versioner (1)
  1. 2020-02-13 2020-02-13 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

13 februari 2020

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Hepatitis C, Chronic NCT01685203

Engelsk

Eligibility Hepatitis C, Chronic NCT01685203

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
females must be practicing specific forms of birth control on study treatment, or be postmenopausal for more than 2 years or surgically sterile
Beskrivning

Gender Contraceptive methods | Postmenopausal state Duration

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C0232970
UMLS CUI [2,2]
C0449238
subjects must meet one of the following:
Beskrivning

Criteria Quantity Fulfill

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C1550543
treatment-naive: subject has never received antiviral treatment for hepatitis c infection or
Beskrivning

Therapy naive | Antiviral Therapy Absent Hepatitis C

Datatyp

boolean

Alias
UMLS CUI [1]
C0919936
UMLS CUI [2,1]
C0280274
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0019196
treatment experienced (prior null responders, partial responders or relapsers to pegifn/rbv);
Beskrivning

Therapeutic procedure Experience | Non-responder PEGINTERFERON/RIBAVIRIN | Partial responder PEGINTERFERON/RIBAVIRIN | Relapse PEGINTERFERON/RIBAVIRIN

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0596545
UMLS CUI [2,1]
C0919875
UMLS CUI [2,2]
C1875630
UMLS CUI [3,1]
C4285679
UMLS CUI [3,2]
C1875630
UMLS CUI [4,1]
C0035020
UMLS CUI [4,2]
C1875630
body mass index (bmi) is ≥ 18 to < 38 kg/m^2.
Beskrivning

Body mass index

Datatyp

boolean

Alias
UMLS CUI [1]
C1305855
chronic hcv genotype 1b infection/with or without cirrhosis or hcv genotype 4 infection/without cirrhosis for at least 6 months prior to study screening.
Beskrivning

Chronic Hepatitis C Genotype Duration | Liver Cirrhosis | Liver Cirrhosis Absent | Hepatitis C Genotype Duration | Liver Cirrhosis Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0524910
UMLS CUI [1,2]
C1533728
UMLS CUI [1,3]
C0449238
UMLS CUI [2]
C0023890
UMLS CUI [3,1]
C0023890
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0019196
UMLS CUI [4,2]
C1533728
UMLS CUI [4,3]
C0449238
UMLS CUI [5,1]
C0023890
UMLS CUI [5,2]
C0332197
subject has plasma hcv rna level > 10,000 iu/ml at screening
Beskrivning

Hepatitis C virus RNA assay Plasma

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1272251
UMLS CUI [1,2]
C0032105
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of severe, life-threatening or other significant sensitivity to any drug.
Beskrivning

Drug Allergy Severe Life Threatening | Drug Allergy Significant

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013182
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C2826244
UMLS CUI [2,1]
C0013182
UMLS CUI [2,2]
C0750502
females who were pregnant or planned to become pregnant, or breastfeeding, or gt4-infected males whose partners were pregnant or planning to become pregnant within 7 months (or per local rbv label) after their last dose of study drug/rbv.
Beskrivning

Pregnancy | Pregnancy, Planned | Breast Feeding | Gender Hepatitis C Genotype | Gender Partner Pregnancy | Gender Partner Planned Pregnancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
UMLS CUI [3]
C0006147
UMLS CUI [4,1]
C0079399
UMLS CUI [4,2]
C0019196
UMLS CUI [4,3]
C1533728
UMLS CUI [5,1]
C0079399
UMLS CUI [5,2]
C0682323
UMLS CUI [5,3]
C0032961
UMLS CUI [6,1]
C0079399
UMLS CUI [6,2]
C0682323
UMLS CUI [6,3]
C0032992
recent history of drug or alcohol abuse that could preclude adherence to the protocol.
Beskrivning

Substance Use Disorder Excludes Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0038586
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0525058
positive test result for hepatitis b surface antigen or anti-human immunodeficiency virus (hiv) antibodies.
Beskrivning

Hepatitis B surface antigen positive | HIV antibody positive

Datatyp

boolean

Alias
UMLS CUI [1]
C0149709
UMLS CUI [2]
C0920548
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Similar models

Eligibility Hepatitis C, Chronic NCT01685203

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Gender Contraceptive methods | Postmenopausal state Duration
Item
females must be practicing specific forms of birth control on study treatment, or be postmenopausal for more than 2 years or surgically sterile
boolean
C0079399 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0232970 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
Criteria Quantity Fulfill
Item
subjects must meet one of the following:
boolean
C0243161 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
Therapy naive | Antiviral Therapy Absent Hepatitis C
Item
treatment-naive: subject has never received antiviral treatment for hepatitis c infection or
boolean
C0919936 (UMLS CUI [1])
C0280274 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0019196 (UMLS CUI [2,3])
Therapeutic procedure Experience | Non-responder PEGINTERFERON/RIBAVIRIN | Partial responder PEGINTERFERON/RIBAVIRIN | Relapse PEGINTERFERON/RIBAVIRIN
Item
treatment experienced (prior null responders, partial responders or relapsers to pegifn/rbv);
boolean
C0087111 (UMLS CUI [1,1])
C0596545 (UMLS CUI [1,2])
C0919875 (UMLS CUI [2,1])
C1875630 (UMLS CUI [2,2])
C4285679 (UMLS CUI [3,1])
C1875630 (UMLS CUI [3,2])
C0035020 (UMLS CUI [4,1])
C1875630 (UMLS CUI [4,2])
Body mass index
Item
body mass index (bmi) is ≥ 18 to < 38 kg/m^2.
boolean
C1305855 (UMLS CUI [1])
Chronic Hepatitis C Genotype Duration | Liver Cirrhosis | Liver Cirrhosis Absent | Hepatitis C Genotype Duration | Liver Cirrhosis Absent
Item
chronic hcv genotype 1b infection/with or without cirrhosis or hcv genotype 4 infection/without cirrhosis for at least 6 months prior to study screening.
boolean
C0524910 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
C0023890 (UMLS CUI [2])
C0023890 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0019196 (UMLS CUI [4,1])
C1533728 (UMLS CUI [4,2])
C0449238 (UMLS CUI [4,3])
C0023890 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
Hepatitis C virus RNA assay Plasma
Item
subject has plasma hcv rna level > 10,000 iu/ml at screening
boolean
C1272251 (UMLS CUI [1,1])
C0032105 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Drug Allergy Severe Life Threatening | Drug Allergy Significant
Item
history of severe, life-threatening or other significant sensitivity to any drug.
boolean
C0013182 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C2826244 (UMLS CUI [1,3])
C0013182 (UMLS CUI [2,1])
C0750502 (UMLS CUI [2,2])
Pregnancy | Pregnancy, Planned | Breast Feeding | Gender Hepatitis C Genotype | Gender Partner Pregnancy | Gender Partner Planned Pregnancy
Item
females who were pregnant or planned to become pregnant, or breastfeeding, or gt4-infected males whose partners were pregnant or planning to become pregnant within 7 months (or per local rbv label) after their last dose of study drug/rbv.
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
C0079399 (UMLS CUI [4,1])
C0019196 (UMLS CUI [4,2])
C1533728 (UMLS CUI [4,3])
C0079399 (UMLS CUI [5,1])
C0682323 (UMLS CUI [5,2])
C0032961 (UMLS CUI [5,3])
C0079399 (UMLS CUI [6,1])
C0682323 (UMLS CUI [6,2])
C0032992 (UMLS CUI [6,3])
Substance Use Disorder Excludes Protocol Compliance
Item
recent history of drug or alcohol abuse that could preclude adherence to the protocol.
boolean
C0038586 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
Hepatitis B surface antigen positive | HIV antibody positive
Item
positive test result for hepatitis b surface antigen or anti-human immunodeficiency virus (hiv) antibodies.
boolean
C0149709 (UMLS CUI [1])
C0920548 (UMLS CUI [2])
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