ID

29743

Description

Rate and Predictors of Relapse in the Treatment of Hepatitis C (Study P05181); ODM derived from: https://clinicaltrials.gov/show/NCT00723645

Link

https://clinicaltrials.gov/show/NCT00723645

Keywords

Versions (1)
  1. 4/17/18 4/17/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 17, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatitis C, Chronic NCT00723645

English

Eligibility Hepatitis C, Chronic NCT00723645

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
participants with chronic hepatitis c virus (hcv)[any genotype] who received pegylated interferon alfa-2b plus ribavirin as first treatment for hepatitis c.
Description

Chronic Hepatitis C HCV genotype Any | peginterferon alfa-2b | Ribavirin | Therapeutic procedure First Hepatitis C

Data type

boolean

Alias
UMLS CUI [1,1]
C0524910
UMLS CUI [1,2]
C1148363
UMLS CUI [1,3]
C1552551
UMLS CUI [2]
C0796545
UMLS CUI [3]
C0035525
UMLS CUI [4,1]
C0087111
UMLS CUI [4,2]
C0205435
UMLS CUI [4,3]
C0019196
negative hcv rna at the end of treatment (24 or 48 weeks according to the product labeling as appropriate), measured by the assay used at each institution. only institutions using an assay with a limit of detection of 50 iu/ml or less will be eligible.
Description

Hepatitis C RNA negative Hepatitis C virus RNA assay | Treatment completed | Hepatitis C virus RNA assay Limit of Detection

Data type

boolean

Alias
UMLS CUI [1,1]
C0855841
UMLS CUI [1,2]
C1272251
UMLS CUI [2]
C0580352
UMLS CUI [3,1]
C1272251
UMLS CUI [3,2]
C2718050
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
women of childbearing potential (i.e., premenopausal women and women who are less than 6 months postmenopausal) who will not use an appropriate contraceptive method during the course of the clinical study. appropriate contraceptives include double barrier methods (eg, diaphragm or condom plus spermicide), intrauterine device, oral, injectable or subcutaneous hormonal contraceptive, or surgically sterilized partner.
Description

Childbearing Potential Contraceptive methods Unwilling | Premenopausal state | Postmenopausal state Duration | Barrier Contraception Double | Vaginal contraceptive diaphragm | Female Condoms | Vaginal Spermicides | Intrauterine Devices | Contraceptives, Oral | Injectable contraception | Subcutaneous contraceptive Hormonal | Partner Male sterilization

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0558080
UMLS CUI [2]
C0232969
UMLS CUI [3,1]
C0232970
UMLS CUI [3,2]
C0449238
UMLS CUI [4,1]
C0004764
UMLS CUI [4,2]
C0205173
UMLS CUI [5]
C0042241
UMLS CUI [6]
C0221829
UMLS CUI [7]
C0087145
UMLS CUI [8]
C0021900
UMLS CUI [9]
C0009905
UMLS CUI [10]
C1262153
UMLS CUI [11,1]
C0459222
UMLS CUI [11,2]
C0458083
UMLS CUI [12,1]
C0682323
UMLS CUI [12,2]
C0024559
completed treatment with pegylated interferon alfa-2b plus ribavirin more than 4 weeks before study entry.
Description

Treatment completed | peginterferon alfa-2b | Ribavirin

Data type

boolean

Alias
UMLS CUI [1]
C0580352
UMLS CUI [2]
C0796545
UMLS CUI [3]
C0035525
positive hcv rna at the end of treatment (24 or 48 weeks according to the product labeling as appropriate).
Description

Hepatitis C RNA positive | Treatment completed

Data type

boolean

Alias
UMLS CUI [1]
C0855842
UMLS CUI [2]
C0580352
participants treated for a period shorter than the enrollment period.
Description

Therapeutic procedure short-term | Enrollment Period failed

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0443303
UMLS CUI [2,1]
C1516879
UMLS CUI [2,2]
C1948053
UMLS CUI [2,3]
C0231175
co-infection with human immumodeficiency virus (hiv).
Description

HIV coinfection

Data type

boolean

Alias
UMLS CUI [1]
C4062778
co-infected with hepatitis b virus (hbv).
Description

HBV coinfection

Data type

boolean

Alias
UMLS CUI [1]
C2242656
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Similar models

Eligibility Hepatitis C, Chronic NCT00723645

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Chronic Hepatitis C HCV genotype Any | peginterferon alfa-2b | Ribavirin | Therapeutic procedure First Hepatitis C
Item
participants with chronic hepatitis c virus (hcv)[any genotype] who received pegylated interferon alfa-2b plus ribavirin as first treatment for hepatitis c.
boolean
C0524910 (UMLS CUI [1,1])
C1148363 (UMLS CUI [1,2])
C1552551 (UMLS CUI [1,3])
C0796545 (UMLS CUI [2])
C0035525 (UMLS CUI [3])
C0087111 (UMLS CUI [4,1])
C0205435 (UMLS CUI [4,2])
C0019196 (UMLS CUI [4,3])
Hepatitis C RNA negative Hepatitis C virus RNA assay | Treatment completed | Hepatitis C virus RNA assay Limit of Detection
Item
negative hcv rna at the end of treatment (24 or 48 weeks according to the product labeling as appropriate), measured by the assay used at each institution. only institutions using an assay with a limit of detection of 50 iu/ml or less will be eligible.
boolean
C0855841 (UMLS CUI [1,1])
C1272251 (UMLS CUI [1,2])
C0580352 (UMLS CUI [2])
C1272251 (UMLS CUI [3,1])
C2718050 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Childbearing Potential Contraceptive methods Unwilling | Premenopausal state | Postmenopausal state Duration | Barrier Contraception Double | Vaginal contraceptive diaphragm | Female Condoms | Vaginal Spermicides | Intrauterine Devices | Contraceptives, Oral | Injectable contraception | Subcutaneous contraceptive Hormonal | Partner Male sterilization
Item
women of childbearing potential (i.e., premenopausal women and women who are less than 6 months postmenopausal) who will not use an appropriate contraceptive method during the course of the clinical study. appropriate contraceptives include double barrier methods (eg, diaphragm or condom plus spermicide), intrauterine device, oral, injectable or subcutaneous hormonal contraceptive, or surgically sterilized partner.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
C0232969 (UMLS CUI [2])
C0232970 (UMLS CUI [3,1])
C0449238 (UMLS CUI [3,2])
C0004764 (UMLS CUI [4,1])
C0205173 (UMLS CUI [4,2])
C0042241 (UMLS CUI [5])
C0221829 (UMLS CUI [6])
C0087145 (UMLS CUI [7])
C0021900 (UMLS CUI [8])
C0009905 (UMLS CUI [9])
C1262153 (UMLS CUI [10])
C0459222 (UMLS CUI [11,1])
C0458083 (UMLS CUI [11,2])
C0682323 (UMLS CUI [12,1])
C0024559 (UMLS CUI [12,2])
Treatment completed | peginterferon alfa-2b | Ribavirin
Item
completed treatment with pegylated interferon alfa-2b plus ribavirin more than 4 weeks before study entry.
boolean
C0580352 (UMLS CUI [1])
C0796545 (UMLS CUI [2])
C0035525 (UMLS CUI [3])
Hepatitis C RNA positive | Treatment completed
Item
positive hcv rna at the end of treatment (24 or 48 weeks according to the product labeling as appropriate).
boolean
C0855842 (UMLS CUI [1])
C0580352 (UMLS CUI [2])
Therapeutic procedure short-term | Enrollment Period failed
Item
participants treated for a period shorter than the enrollment period.
boolean
C0087111 (UMLS CUI [1,1])
C0443303 (UMLS CUI [1,2])
C1516879 (UMLS CUI [2,1])
C1948053 (UMLS CUI [2,2])
C0231175 (UMLS CUI [2,3])
HIV coinfection
Item
co-infection with human immumodeficiency virus (hiv).
boolean
C4062778 (UMLS CUI [1])
HBV coinfection
Item
co-infected with hepatitis b virus (hbv).
boolean
C2242656 (UMLS CUI [1])
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