ID

39628

Beskrivning

A Pilot Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of ABT-450 With Ritonavir (ABT-450/r) Dosed in Combination With ABT-072 and Ribavirin (RBV); ODM derived from: https://clinicaltrials.gov/show/NCT01221298

Länk

https://clinicaltrials.gov/show/NCT01221298

Nyckelord

Versioner (1)
  1. 2020-02-05 2020-02-05 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

5 februari 2020

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Hepatitis C NCT01221298

Engelsk

Eligibility Hepatitis C NCT01221298

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
chronic hepatitis c, genotype 1 infection with interleukin 28b (il28b) rs12979860 genotype c/c.
Beskrivning

Chronic Hepatitis C Genotype | IL28B gene associated variant rs12979860

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0524910
UMLS CUI [1,2]
C1533728
UMLS CUI [2]
C3476056
liver biopsy within 3 years with histology consistent with hepatitis c virus (hcv) -
Beskrivning

Biopsy of liver | Histology Consistent with Hepatitis C virus

Datatyp

boolean

Alias
UMLS CUI [1]
C0193388
UMLS CUI [2,1]
C0344441
UMLS CUI [2,2]
C0332290
UMLS CUI [2,3]
C0220847
induced liver damage, with no evidence of cirrhosis or liver pathology due to any cause other than chronic hcv.
Beskrivning

Liver damage Induced | Liver Cirrhosis Absent | Liver disease Absent | Etiology Except Chronic Hepatitis C

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0151763
UMLS CUI [1,2]
C0205263
UMLS CUI [2,1]
C0023890
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0023895
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0015127
UMLS CUI [4,2]
C0332300
UMLS CUI [4,3]
C0524910
treatment naïve male or female between the ages of 18 and 65.
Beskrivning

Therapy naive | Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0919936
UMLS CUI [2]
C0001779
females must be postmenopausal for at least 2 years or surgically sterile.
Beskrivning

Postmenopausal state Duration | Female Sterilization

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0232970
UMLS CUI [1,2]
C0449238
UMLS CUI [2]
C0015787
be in a condition of general good health, as perceived by the investigator, other than hepatitis c virus infection.
Beskrivning

General health good | Exception Hepatitis C

Datatyp

boolean

Alias
UMLS CUI [1]
C1277245
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0019196
body mass index 18 to < 35 kg/m^2 .
Beskrivning

Body mass index

Datatyp

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
significant sensitivity to any drug.
Beskrivning

Drug Allergy

Datatyp

boolean

Alias
UMLS CUI [1]
C0013182
use of herbal supplements within 2 weeks prior to study drug dosing.
Beskrivning

Herbal Supplements

Datatyp

boolean

Alias
UMLS CUI [1]
C1504473
positive screen for certain drugs or alcohol.
Beskrivning

Drug screen positive | Blood alcohol test positive

Datatyp

boolean

Alias
UMLS CUI [1]
C0743295
UMLS CUI [2]
C0948726
positive hepatitis b surface antigen or anti-human immunodeficiency virus (hiv) antibody.
Beskrivning

Hepatitis B surface antigen positive | HIV antibody positive

Datatyp

boolean

Alias
UMLS CUI [1]
C0149709
UMLS CUI [2]
C0920548
use of strong cytochrome p450 3a (cyp3a), cytochrome p450 2c8 (cyp2c8), and organic anion transporting polypeptide 1b1 (oatp1b1) enzyme inducers or inhibitors within 1 month of dosing.
Beskrivning

CYP3A Inducers Strong | CYP2C8 Inducers Strong | OATP1B1 Enzyme Inducers Strong | CYP3A Inhibitors Strong | CYP2C8 Inhibitors Strong | Organic Anion Transporting Polypeptide 1B1 Inhibitors Strong

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3850044
UMLS CUI [1,2]
C0442821
UMLS CUI [2,1]
C3850048
UMLS CUI [2,2]
C0442821
UMLS CUI [3,1]
C1420131
UMLS CUI [3,2]
C3819045
UMLS CUI [3,3]
C0442821
UMLS CUI [4,1]
C3850056
UMLS CUI [4,2]
C0442821
UMLS CUI [5,1]
C3850061
UMLS CUI [5,2]
C0442821
UMLS CUI [6,1]
C3819042
UMLS CUI [6,2]
C0442821
prior treatment with any investigational or commercially available anti-hepatitis c virus agents.
Beskrivning

Anti-hepatitis C (HCV) Agents Investigational | Anti-hepatitis C (HCV) Agents

Datatyp

boolean

Alias
UMLS CUI [1,1]
C4324240
UMLS CUI [1,2]
C1517586
UMLS CUI [2]
C4324240
abnormal laboratory tests.
Beskrivning

Laboratory test result abnormal

Datatyp

boolean

Alias
UMLS CUI [1]
C0438215
cirrhosis or extensive bridging fibrosis.
Beskrivning

Liver Cirrhosis | Bridging fibrosis Extensive

Datatyp

boolean

Alias
UMLS CUI [1]
C0023890
UMLS CUI [2,1]
C0334160
UMLS CUI [2,2]
C0205231
history of cardiac disease.
Beskrivning

Heart Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0018799
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Similar models

Eligibility Hepatitis C NCT01221298

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Chronic Hepatitis C Genotype | IL28B gene associated variant rs12979860
Item
chronic hepatitis c, genotype 1 infection with interleukin 28b (il28b) rs12979860 genotype c/c.
boolean
C0524910 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
C3476056 (UMLS CUI [2])
Biopsy of liver | Histology Consistent with Hepatitis C virus
Item
liver biopsy within 3 years with histology consistent with hepatitis c virus (hcv) -
boolean
C0193388 (UMLS CUI [1])
C0344441 (UMLS CUI [2,1])
C0332290 (UMLS CUI [2,2])
C0220847 (UMLS CUI [2,3])
Liver damage Induced | Liver Cirrhosis Absent | Liver disease Absent | Etiology Except Chronic Hepatitis C
Item
induced liver damage, with no evidence of cirrhosis or liver pathology due to any cause other than chronic hcv.
boolean
C0151763 (UMLS CUI [1,1])
C0205263 (UMLS CUI [1,2])
C0023890 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0023895 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0015127 (UMLS CUI [4,1])
C0332300 (UMLS CUI [4,2])
C0524910 (UMLS CUI [4,3])
Therapy naive | Age
Item
treatment naïve male or female between the ages of 18 and 65.
boolean
C0919936 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Postmenopausal state Duration | Female Sterilization
Item
females must be postmenopausal for at least 2 years or surgically sterile.
boolean
C0232970 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0015787 (UMLS CUI [2])
General health good | Exception Hepatitis C
Item
be in a condition of general good health, as perceived by the investigator, other than hepatitis c virus infection.
boolean
C1277245 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0019196 (UMLS CUI [2,2])
Body mass index
Item
body mass index 18 to < 35 kg/m^2 .
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Drug Allergy
Item
significant sensitivity to any drug.
boolean
C0013182 (UMLS CUI [1])
Herbal Supplements
Item
use of herbal supplements within 2 weeks prior to study drug dosing.
boolean
C1504473 (UMLS CUI [1])
Drug screen positive | Blood alcohol test positive
Item
positive screen for certain drugs or alcohol.
boolean
C0743295 (UMLS CUI [1])
C0948726 (UMLS CUI [2])
Hepatitis B surface antigen positive | HIV antibody positive
Item
positive hepatitis b surface antigen or anti-human immunodeficiency virus (hiv) antibody.
boolean
C0149709 (UMLS CUI [1])
C0920548 (UMLS CUI [2])
CYP3A Inducers Strong | CYP2C8 Inducers Strong | OATP1B1 Enzyme Inducers Strong | CYP3A Inhibitors Strong | CYP2C8 Inhibitors Strong | Organic Anion Transporting Polypeptide 1B1 Inhibitors Strong
Item
use of strong cytochrome p450 3a (cyp3a), cytochrome p450 2c8 (cyp2c8), and organic anion transporting polypeptide 1b1 (oatp1b1) enzyme inducers or inhibitors within 1 month of dosing.
boolean
C3850044 (UMLS CUI [1,1])
C0442821 (UMLS CUI [1,2])
C3850048 (UMLS CUI [2,1])
C0442821 (UMLS CUI [2,2])
C1420131 (UMLS CUI [3,1])
C3819045 (UMLS CUI [3,2])
C0442821 (UMLS CUI [3,3])
C3850056 (UMLS CUI [4,1])
C0442821 (UMLS CUI [4,2])
C3850061 (UMLS CUI [5,1])
C0442821 (UMLS CUI [5,2])
C3819042 (UMLS CUI [6,1])
C0442821 (UMLS CUI [6,2])
Anti-hepatitis C (HCV) Agents Investigational | Anti-hepatitis C (HCV) Agents
Item
prior treatment with any investigational or commercially available anti-hepatitis c virus agents.
boolean
C4324240 (UMLS CUI [1,1])
C1517586 (UMLS CUI [1,2])
C4324240 (UMLS CUI [2])
Laboratory test result abnormal
Item
abnormal laboratory tests.
boolean
C0438215 (UMLS CUI [1])
Liver Cirrhosis | Bridging fibrosis Extensive
Item
cirrhosis or extensive bridging fibrosis.
boolean
C0023890 (UMLS CUI [1])
C0334160 (UMLS CUI [2,1])
C0205231 (UMLS CUI [2,2])
Heart Disease
Item
history of cardiac disease.
boolean
C0018799 (UMLS CUI [1])
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