ID

20947

Beskrivning

Safety and PK Study of NOV-205 to Treat Chronic HCV Who Fail Standard Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT00372983

Länk

https://clinicaltrials.gov/show/NCT00372983

Nyckelord

Versioner (1)
  1. 2017-03-30 2017-03-30 -
Uppladdad den

30 mars 2017

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Hepatitis C NCT00372983

Engelsk

Eligibility Hepatitis C NCT00372983

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
a serum hcv rna level of >100,000 iu/ml using a quantitative, branched-chain-dna (bdna)-based assay (lower limit of quantitation = ~650 iu/ml) or other equally sensitive quantitative methods.
Beskrivning

HCV viral load Level Branched DNA Assay

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1868902
UMLS CUI [1,2]
C0441889
UMLS CUI [1,3]
C0887812
infection with genotype 1 hcv
Beskrivning

Hepatitis C virus genotype Infection

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1148363
UMLS CUI [1,2]
C3714514
documented failure to respond to treatment (defined as a patient who did not achieve an early viral response (evr) (≥2 log reduction in serum hcv rna or undetectable hcv rna after 12 weeks of treatment) or is serum hcv rna positive after 24 weeks of treatment with pegylated interferon plus ribavirin for hepatitis c.
Beskrivning

Absence of therapeutic response | Response Viral Early Absent | HCV viral load Reduction | HCV viral load Undetectable | Hepatitis C RNA positive | pegylated interferon alfa | Ribavirin | Therapeutic procedure Hepatitis C

Datatyp

boolean

Alias
UMLS CUI [1]
C0521983
UMLS CUI [2,1]
C0871261
UMLS CUI [2,2]
C0521026
UMLS CUI [2,3]
C1279919
UMLS CUI [2,4]
C0332197
UMLS CUI [3,1]
C1868902
UMLS CUI [3,2]
C0392756
UMLS CUI [4,1]
C1868902
UMLS CUI [4,2]
C3827727
UMLS CUI [5]
C0855842
UMLS CUI [6]
C0907160
UMLS CUI [7]
C0035525
UMLS CUI [8,1]
C0087111
UMLS CUI [8,2]
C0019196
women of childbearing potential willing to use two acceptable methods of birth control during trial participation or are sterile or post-menopausal (defined as not having a menstrual cycle for greater than two years)
Beskrivning

Childbearing Potential Contraceptive methods Quantity | Infertility | Postmenopausal state | Menstrual cycle Absent Duration

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C1265611
UMLS CUI [2]
C0021359
UMLS CUI [3]
C0232970
UMLS CUI [4,1]
C0025329
UMLS CUI [4,2]
C0332197
UMLS CUI [4,3]
C0449238
sexually active male subjects are practicing acceptable methods of contraception during trial participation
Beskrivning

Gender Sex Behavior Contraceptive methods

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0036864
UMLS CUI [1,3]
C0700589
have the ability to understand the requirements of the trial, have provided written informed consent, and agree to abide by the trial restrictions and to return for the required assessments
Beskrivning

Informed Consent | Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C0525058
the subject must be able to self administer daily subcutaneous injections or their caregiver must be able to administer daily subcutaneous injections
Beskrivning

Subcutaneous Injections Self Administration Daily | Caregiver Subcutaneous Injections Administration Daily

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021499
UMLS CUI [1,2]
C0036589
UMLS CUI [1,3]
C0332173
UMLS CUI [2,1]
C0085537
UMLS CUI [2,2]
C0021499
UMLS CUI [2,3]
C1533734
UMLS CUI [2,4]
C0332173
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
clinical, laboratory, or histological evidence of liver cirrhosis
Beskrivning

Liver Cirrhosis Evidence of

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0023890
UMLS CUI [1,2]
C0332120
evidence of hepatic decompensation (presence of or a history of ascites, hepatic encephalopathy, variceal bleeding, or hepatocellular carcinoma)
Beskrivning

Hepatic decompensation Evidence of | Ascites | Hepatic Encephalopathy | Bleeding varices | Liver carcinoma

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1394798
UMLS CUI [1,2]
C0332120
UMLS CUI [2]
C0003962
UMLS CUI [3]
C0019151
UMLS CUI [4]
C0333106
UMLS CUI [5]
C2239176
co-infection with human immunodeficiency virus (hiv) or active hepatitis b virus (hbv) (as determined by presence of hepatitis b surface antigen (hbsag)
Beskrivning

HIV coinfection | HBV coinfection | Hepatitis B Surface Antigens Presence

Datatyp

boolean

Alias
UMLS CUI [1]
C4062778
UMLS CUI [2]
C2242656
UMLS CUI [3,1]
C0019168
UMLS CUI [3,2]
C0150312
have received pegylated interferon and/or ribavirin within the 60 days prior to randomization
Beskrivning

pegylated interferon alfa | Ribavirin

Datatyp

boolean

Alias
UMLS CUI [1]
C0907160
UMLS CUI [2]
C0035525
any known preexisting medical condition that could interfere with the subject's participation in and completion of the protocol
Beskrivning

Medical condition Interferes with Study Subject Participation Status | Medical condition Interferes with Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2348568
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0525058
pregnant female or nursing mother
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
Tillbaka till toppen

Similar models

Eligibility Hepatitis C NCT00372983

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
HCV viral load Level Branched DNA Assay
Item
a serum hcv rna level of >100,000 iu/ml using a quantitative, branched-chain-dna (bdna)-based assay (lower limit of quantitation = ~650 iu/ml) or other equally sensitive quantitative methods.
boolean
C1868902 (UMLS CUI [1,1])
C0441889 (UMLS CUI [1,2])
C0887812 (UMLS CUI [1,3])
Hepatitis C virus genotype Infection
Item
infection with genotype 1 hcv
boolean
C1148363 (UMLS CUI [1,1])
C3714514 (UMLS CUI [1,2])
Absence of therapeutic response | Response Viral Early Absent | HCV viral load Reduction | HCV viral load Undetectable | Hepatitis C RNA positive | pegylated interferon alfa | Ribavirin | Therapeutic procedure Hepatitis C
Item
documented failure to respond to treatment (defined as a patient who did not achieve an early viral response (evr) (≥2 log reduction in serum hcv rna or undetectable hcv rna after 12 weeks of treatment) or is serum hcv rna positive after 24 weeks of treatment with pegylated interferon plus ribavirin for hepatitis c.
boolean
C0521983 (UMLS CUI [1])
C0871261 (UMLS CUI [2,1])
C0521026 (UMLS CUI [2,2])
C1279919 (UMLS CUI [2,3])
C0332197 (UMLS CUI [2,4])
C1868902 (UMLS CUI [3,1])
C0392756 (UMLS CUI [3,2])
C1868902 (UMLS CUI [4,1])
C3827727 (UMLS CUI [4,2])
C0855842 (UMLS CUI [5])
C0907160 (UMLS CUI [6])
C0035525 (UMLS CUI [7])
C0087111 (UMLS CUI [8,1])
C0019196 (UMLS CUI [8,2])
Childbearing Potential Contraceptive methods Quantity | Infertility | Postmenopausal state | Menstrual cycle Absent Duration
Item
women of childbearing potential willing to use two acceptable methods of birth control during trial participation or are sterile or post-menopausal (defined as not having a menstrual cycle for greater than two years)
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0021359 (UMLS CUI [2])
C0232970 (UMLS CUI [3])
C0025329 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0449238 (UMLS CUI [4,3])
Gender Sex Behavior Contraceptive methods
Item
sexually active male subjects are practicing acceptable methods of contraception during trial participation
boolean
C0079399 (UMLS CUI [1,1])
C0036864 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])
Informed Consent | Protocol Compliance
Item
have the ability to understand the requirements of the trial, have provided written informed consent, and agree to abide by the trial restrictions and to return for the required assessments
boolean
C0021430 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
Subcutaneous Injections Self Administration Daily | Caregiver Subcutaneous Injections Administration Daily
Item
the subject must be able to self administer daily subcutaneous injections or their caregiver must be able to administer daily subcutaneous injections
boolean
C0021499 (UMLS CUI [1,1])
C0036589 (UMLS CUI [1,2])
C0332173 (UMLS CUI [1,3])
C0085537 (UMLS CUI [2,1])
C0021499 (UMLS CUI [2,2])
C1533734 (UMLS CUI [2,3])
C0332173 (UMLS CUI [2,4])
Item Group
C0680251 (UMLS CUI)
Liver Cirrhosis Evidence of
Item
clinical, laboratory, or histological evidence of liver cirrhosis
boolean
C0023890 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
Hepatic decompensation Evidence of | Ascites | Hepatic Encephalopathy | Bleeding varices | Liver carcinoma
Item
evidence of hepatic decompensation (presence of or a history of ascites, hepatic encephalopathy, variceal bleeding, or hepatocellular carcinoma)
boolean
C1394798 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
C0003962 (UMLS CUI [2])
C0019151 (UMLS CUI [3])
C0333106 (UMLS CUI [4])
C2239176 (UMLS CUI [5])
HIV coinfection | HBV coinfection | Hepatitis B Surface Antigens Presence
Item
co-infection with human immunodeficiency virus (hiv) or active hepatitis b virus (hbv) (as determined by presence of hepatitis b surface antigen (hbsag)
boolean
C4062778 (UMLS CUI [1])
C2242656 (UMLS CUI [2])
C0019168 (UMLS CUI [3,1])
C0150312 (UMLS CUI [3,2])
pegylated interferon alfa | Ribavirin
Item
have received pegylated interferon and/or ribavirin within the 60 days prior to randomization
boolean
C0907160 (UMLS CUI [1])
C0035525 (UMLS CUI [2])
Medical condition Interferes with Study Subject Participation Status | Medical condition Interferes with Protocol Compliance
Item
any known preexisting medical condition that could interfere with the subject's participation in and completion of the protocol
boolean
C3843040 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
Pregnancy | Breast Feeding
Item
pregnant female or nursing mother
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Tillbaka till toppen 

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