ID

40976

Description

A Trial of NOV-205 in Hepatitis C Patients Who Failed Standard Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT01058512

Link

https://clinicaltrials.gov/show/NCT01058512

Keywords

Versions (1)
  1. 6/7/20 6/7/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 7, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatitis C NCT01058512

English

Eligibility Hepatitis C NCT01058512

1 forms  
Inclusion Criteria
Description

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.
Description

Hepatitis C virus RNA assay | Branched Chain DNA Assay

Data type

boolean

Alias
UMLS CUI [1]
C1272251
UMLS CUI [2,1]
C1553156
UMLS CUI [2,2]
C1510438
infection with genotype 1 hcv
Description

Hepatitis C Genotype

Data type

boolean

Alias
UMLS CUI [1,1]
C0019196
UMLS CUI [1,2]
C1533728
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
Description

Therapy non-responder | Antiviral Response Early failed | Hepatitis C virus RNA assay | Hepatitis C RNA positive Post PEGINTERFERON/RIBAVIRIN

Data type

boolean

Alias
UMLS CUI [1]
C0919875
UMLS CUI [2,1]
C1155328
UMLS CUI [2,2]
C1279919
UMLS CUI [2,3]
C0231175
UMLS CUI [3]
C1272251
UMLS CUI [4,1]
C0855842
UMLS CUI [4,2]
C0687676
UMLS CUI [4,3]
C1875630
adequate laboratory parameters
Description

Laboratory Results Adequate

Data type

boolean

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C0205411
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)
Description

Childbearing Potential Contraceptive methods Quantity | Female Sterilization | Postmenopausal state

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C1265611
UMLS CUI [2]
C0015787
UMLS CUI [3]
C0232970
sexually active male subjects are practicing acceptable methods of contraception during trial participation
Description

Gender Sexually active Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0241028
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
Description

Informed Consent | Protocol Compliance

Data type

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
Description

Self Administration Subcutaneous Injections Daily | Caregiver Subcutaneous Injections Daily

Data type

boolean

Alias
UMLS CUI [1,1]
C0036589
UMLS CUI [1,2]
C0021499
UMLS CUI [1,3]
C0332173
UMLS CUI [2,1]
C0085537
UMLS CUI [2,2]
C0021499
UMLS CUI [2,3]
C0332173
Exclusion Criteria
Description

Exclusion Criteria

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

Liver Cirrhosis

Data type

boolean

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

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

Data type

boolean

Alias
UMLS CUI [1]
C1394798
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)
Description

HIV coinfection | HBV coinfection | Hepatitis B Surface Antigens Present

Data type

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 enrollment
Description

PEGINTERFERON Recent | Ribavirin Recent

Data type

boolean

Alias
UMLS CUI [1,1]
C0982327
UMLS CUI [1,2]
C0332185
UMLS CUI [2,1]
C0035525
UMLS CUI [2,2]
C0332185
any known preexisting medical condition that could interfere with the subject's participation in and completion of the protocol
Description

Medical condition Interferes with Study Subject Participation Status | Medical condition Interferes with Completion of clinical trial

Data type

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]
C2732579
pregnant female or nursing mother
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Hepatitis C NCT01058512

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Hepatitis C virus RNA assay | Branched Chain 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
C1272251 (UMLS CUI [1])
C1553156 (UMLS CUI [2,1])
C1510438 (UMLS CUI [2,2])
Hepatitis C Genotype
Item
infection with genotype 1 hcv
boolean
C0019196 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
Therapy non-responder | Antiviral Response Early failed | Hepatitis C virus RNA assay | Hepatitis C RNA positive Post PEGINTERFERON/RIBAVIRIN
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
C0919875 (UMLS CUI [1])
C1155328 (UMLS CUI [2,1])
C1279919 (UMLS CUI [2,2])
C0231175 (UMLS CUI [2,3])
C1272251 (UMLS CUI [3])
C0855842 (UMLS CUI [4,1])
C0687676 (UMLS CUI [4,2])
C1875630 (UMLS CUI [4,3])
Laboratory Results Adequate
Item
adequate laboratory parameters
boolean
C1254595 (UMLS CUI [1,1])
C0205411 (UMLS CUI [1,2])
Childbearing Potential Contraceptive methods Quantity | Female Sterilization | Postmenopausal state
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])
C0015787 (UMLS CUI [2])
C0232970 (UMLS CUI [3])
Gender Sexually active Contraceptive methods
Item
sexually active male subjects are practicing acceptable methods of contraception during trial participation
boolean
C0079399 (UMLS CUI [1,1])
C0241028 (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])
Self Administration Subcutaneous Injections Daily | Caregiver Subcutaneous Injections 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
C0036589 (UMLS CUI [1,1])
C0021499 (UMLS CUI [1,2])
C0332173 (UMLS CUI [1,3])
C0085537 (UMLS CUI [2,1])
C0021499 (UMLS CUI [2,2])
C0332173 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Liver Cirrhosis
Item
clinical, laboratory, or histological evidence of liver cirrhosis
boolean
C0023890 (UMLS CUI [1])
Hepatic decompensation | 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])
C0003962 (UMLS CUI [2])
C0019151 (UMLS CUI [3])
C0333106 (UMLS CUI [4])
C2239176 (UMLS CUI [5])
HIV coinfection | HBV coinfection | Hepatitis B Surface Antigens Present
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])
PEGINTERFERON Recent | Ribavirin Recent
Item
have received pegylated interferon and/or ribavirin within the 60 days prior to enrollment
boolean
C0982327 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0035525 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
Medical condition Interferes with Study Subject Participation Status | Medical condition Interferes with Completion of clinical trial
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])
C2732579 (UMLS CUI [2,3])
Pregnancy | Breast Feeding
Item
pregnant female or nursing mother
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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