ID

16276

Description

Safety and Antiviral Activity Study of ACH-126,443 (Beta-L-Fd4C) in Treatment Naive Adults With Chronic Hepatitis B Virus Infection; ODM derived from: https://clinicaltrials.gov/show/NCT00034359

Link

https://clinicaltrials.gov/show/NCT00034359

Keywords

Versions (1)
  1. 7/8/16 7/8/16 -
Uploaded on

July 8, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatitis B, Chronic NCT00034359

English

Eligibility Hepatitis B, Chronic NCT00034359

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
adults >= 18 years of age
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
chronic hbv infection, known to be hbsag positive >= 6 months
Description

chronic hbv infection, hbsag positive

Data type

boolean

Alias
UMLS CUI [1]
C0149709
plasma hbv dna level >= 100,000 copies/ml
Description

plasma hbv dna level

Data type

boolean

Alias
UMLS CUI [1]
C3641250
hbe-antigen positive
Description

hbe-antigen positive

Data type

boolean

Alias
UMLS CUI [1]
C0392390
hiv negative
Description

hiv negative

Data type

boolean

Alias
UMLS CUI [1]
C0481430
basic hematologic and chemistry parameters within acceptable limits (defined in protocol
Description

normal blood test

Data type

boolean

Alias
UMLS CUI [1]
C0919709
no need for excluded medications
Description

medication

Data type

boolean

Alias
UMLS CUI [1]
C0013227
subjects of reproductive capability must utilize two approved forms of birth control, one of which must be barrier protection.
Description

contraceptive methods

Data type

boolean

Alias
UMLS CUI [1]
C0700589
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
hiv infection
Description

hiv infection

Data type

boolean

Alias
UMLS CUI [1]
C0019693
hepatitis c co-infection
Description

hepatitis c co-infection

Data type

boolean

Alias
UMLS CUI [1]
C1112419
concurrent systemic antiviral treatment
Description

concurrent systemic antiviral treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C0009429
UMLS CUI [1,2]
C2363964
previous antiviral treatment for hbv infection within 6 months prior to randomization or treatment with 3tc for more than 6 months at any time in the past
Description

prior antiviral treatment or treatment with 3tc

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C2363964
UMLS CUI [2,1]
C1514463
UMLS CUI [2,2]
C0209738
previous therapy with agents with significant systemic myelosuppressive or cytotoxic potential within 3 months of study start or the expected need for such therapy at study start
Description

prior myelosuppressive or cytotoxic therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C1513793
UMLS CUI [2,1]
C1514463
UMLS CUI [2,2]
C0677881
alcohol abuse
Description

alcohol abuse

Data type

boolean

Alias
UMLS CUI [1]
C0038586
pregnancy or breast-feeding
Description

pregnancy or breast-feeding

Data type

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0006147
inability to tolerate oral medication
Description

inability to tolerate oral medication

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0001563
ast>7.0 times the upper limit of normal
Description

ast

Data type

boolean

Alias
UMLS CUI [1]
C0201899
alt>7.0 times the upper limit of normal
Description

alt

Data type

boolean

any clinical condition or prior therapy that, in the investigators opinion, would make the subject unsuitable for the study or unable to comply with the dosing requirements
Description

exclusion criteria

Data type

boolean

Alias
UMLS CUI [1]
C0680251
use of any investigational drug.
Description

use of any investigational drug

Data type

boolean

Alias
UMLS CUI [1]
C0013230
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Similar models

Eligibility Hepatitis B, Chronic NCT00034359

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
age
Item
adults >= 18 years of age
boolean
C0001779 (UMLS CUI [1])
chronic hbv infection, hbsag positive
Item
chronic hbv infection, known to be hbsag positive >= 6 months
boolean
C0149709 (UMLS CUI [1])
plasma hbv dna level
Item
plasma hbv dna level >= 100,000 copies/ml
boolean
C3641250 (UMLS CUI [1])
hbe-antigen positive
Item
hbe-antigen positive
boolean
C0392390 (UMLS CUI [1])
hiv negative
Item
hiv negative
boolean
C0481430 (UMLS CUI [1])
normal blood test
Item
basic hematologic and chemistry parameters within acceptable limits (defined in protocol
boolean
C0919709 (UMLS CUI [1])
medication
Item
no need for excluded medications
boolean
C0013227 (UMLS CUI [1])
contraceptive methods
Item
subjects of reproductive capability must utilize two approved forms of birth control, one of which must be barrier protection.
boolean
C0700589 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
hiv infection
Item
hiv infection
boolean
C0019693 (UMLS CUI [1])
hepatitis c co-infection
Item
hepatitis c co-infection
boolean
C1112419 (UMLS CUI [1])
concurrent systemic antiviral treatment
Item
concurrent systemic antiviral treatment
boolean
C0009429 (UMLS CUI [1,1])
C2363964 (UMLS CUI [1,2])
prior antiviral treatment or treatment with 3tc
Item
previous antiviral treatment for hbv infection within 6 months prior to randomization or treatment with 3tc for more than 6 months at any time in the past
boolean
C1514463 (UMLS CUI [1,1])
C2363964 (UMLS CUI [1,2])
C1514463 (UMLS CUI [2,1])
C0209738 (UMLS CUI [2,2])
prior myelosuppressive or cytotoxic therapy
Item
previous therapy with agents with significant systemic myelosuppressive or cytotoxic potential within 3 months of study start or the expected need for such therapy at study start
boolean
C1514463 (UMLS CUI [1,1])
C1513793 (UMLS CUI [1,2])
C1514463 (UMLS CUI [2,1])
C0677881 (UMLS CUI [2,2])
alcohol abuse
Item
alcohol abuse
boolean
C0038586 (UMLS CUI [1])
pregnancy or breast-feeding
Item
pregnancy or breast-feeding
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
inability to tolerate oral medication
Item
inability to tolerate oral medication
boolean
C0009488 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0001563 (UMLS CUI [1,3])
ast
Item
ast>7.0 times the upper limit of normal
boolean
C0201899 (UMLS CUI [1])
alt
Item
alt>7.0 times the upper limit of normal
boolean
exclusion criteria
Item
any clinical condition or prior therapy that, in the investigators opinion, would make the subject unsuitable for the study or unable to comply with the dosing requirements
boolean
C0680251 (UMLS CUI [1])
use of any investigational drug
Item
use of any investigational drug.
boolean
C0013230 (UMLS CUI [1])
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