ID

14217

Description

Triple Therapy With Peg-Interferon Alfa-2b/Ribavirin Plus Amantadine Compared to Standard Peg-Interferon Alfa-2b/Ribavirin for Previous Hepatitis C Virus (HCV) Non Responders; ODM derived from: https://clinicaltrials.gov/show/NCT00122629

Link

https://clinicaltrials.gov/show/NCT00122629

Keywords

Versions (1)
  1. 4/4/16 4/4/16 -
Uploaded on

April 4, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatitis C, Chronic NCT00122629

English

Eligibility Hepatitis C, Chronic NCT00122629

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
positive anti-hcv antibody test
Description

Anti-hcv antibody test

Data type

boolean

Alias
UMLS CUI [1]
C0201487
patients who did not respond to treatment with standard interferon + ribavirin (hcv rna+ by pcr in the last month of treatment)
Description

Response to standard HCV treatment (by HCV RNA)

Data type

boolean

Alias
UMLS CUI [1,1]
C0521982
UMLS CUI [1,2]
C0717864
UMLS CUI [2]
C0369335
compensated liver disease
Description

Liver function

Data type

boolean

Alias
UMLS CUI [1]
C0232741
neutrophil count over or equal to1000/mm3
Description

Neutrophil count

Data type

boolean

Alias
UMLS CUI [1]
C0200633
platelet count over or equal to 100 giga/l
Description

Platelet count

Data type

boolean

Alias
UMLS CUI [1]
C0032181
haemoglobin over or equal to 10g/dl
Description

Haemoglobin

Data type

boolean

Alias
UMLS CUI [1]
C0518015
patients had to have undergone a post-treatment liver biopsy within a year, showing a metavir histological score over or equal to a1f1, without cirrhosis (fibrosis score below f4)
Description

Post-treatment liver biopsy (metavir histological score + fibrosis score)

Data type

boolean

Alias
UMLS CUI [1,1]
C0193388
UMLS CUI [1,2]
C2709088
UMLS CUI [2]
C3888527
UMLS CUI [3]
C1954437
alt over n and hcv rna+ at screening
Description

ALT measurement and HCV RNA

Data type

boolean

Alias
UMLS CUI [1]
C0201836
UMLS CUI [2]
C0369335
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
co-infection with hepatitis b or human immunodeficiency virus
Description

Co-infections

Data type

boolean

Alias
UMLS CUI [1]
C2242656
UMLS CUI [2,1]
C0275524
UMLS CUI [2,2]
C0019682
any other cause of liver disease
Description

Liver disease etiology

Data type

boolean

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C1314792
active drug abuse, active alcohol consumption above 40g/day
Description

Substance use disorder

Data type

boolean

Alias
UMLS CUI [1]
C0038586
organ grafts
Description

Organ graft

Data type

boolean

Alias
UMLS CUI [1]
C0524930
presence of hepatocellular carcinoma
Description

Hepatocellular carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C2239176
cardiovascular, metabolic, renal, haematological, neurological or psychiatric disease
Description

Comorbidity

Data type

boolean

Alias
UMLS CUI [1]
C0009488
patients with previous amantadine use
Description

Amantadine

Data type

boolean

Alias
UMLS CUI [1]
C0002403
systemic immunosuppressive or antiviral treatment during the last 24 weeks and those with a history of interferon and/or ribavirin intolerance
Description

Immunossuppressive or antiviral treatment and drug intolerance

Data type

boolean

Alias
UMLS CUI [1]
C0021079
UMLS CUI [2]
C2363964
UMLS CUI [3]
C0277585
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Similar models

Eligibility Hepatitis C, Chronic NCT00122629

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Anti-hcv antibody test
Item
positive anti-hcv antibody test
boolean
C0201487 (UMLS CUI [1])
Response to standard HCV treatment (by HCV RNA)
Item
patients who did not respond to treatment with standard interferon + ribavirin (hcv rna+ by pcr in the last month of treatment)
boolean
C0521982 (UMLS CUI [1,1])
C0717864 (UMLS CUI [1,2])
C0369335 (UMLS CUI [2])
Liver function
Item
compensated liver disease
boolean
C0232741 (UMLS CUI [1])
Neutrophil count
Item
neutrophil count over or equal to1000/mm3
boolean
C0200633 (UMLS CUI [1])
Platelet count
Item
platelet count over or equal to 100 giga/l
boolean
C0032181 (UMLS CUI [1])
Haemoglobin
Item
haemoglobin over or equal to 10g/dl
boolean
C0518015 (UMLS CUI [1])
Post-treatment liver biopsy (metavir histological score + fibrosis score)
Item
patients had to have undergone a post-treatment liver biopsy within a year, showing a metavir histological score over or equal to a1f1, without cirrhosis (fibrosis score below f4)
boolean
C0193388 (UMLS CUI [1,1])
C2709088 (UMLS CUI [1,2])
C3888527 (UMLS CUI [2])
C1954437 (UMLS CUI [3])
ALT measurement and HCV RNA
Item
alt over n and hcv rna+ at screening
boolean
C0201836 (UMLS CUI [1])
C0369335 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Co-infections
Item
co-infection with hepatitis b or human immunodeficiency virus
boolean
C2242656 (UMLS CUI [1])
C0275524 (UMLS CUI [2,1])
C0019682 (UMLS CUI [2,2])
Liver disease etiology
Item
any other cause of liver disease
boolean
C0023895 (UMLS CUI [1,1])
C1314792 (UMLS CUI [1,2])
Substance use disorder
Item
active drug abuse, active alcohol consumption above 40g/day
boolean
C0038586 (UMLS CUI [1])
Organ graft
Item
organ grafts
boolean
C0524930 (UMLS CUI [1])
Hepatocellular carcinoma
Item
presence of hepatocellular carcinoma
boolean
C2239176 (UMLS CUI [1])
Comorbidity
Item
cardiovascular, metabolic, renal, haematological, neurological or psychiatric disease
boolean
C0009488 (UMLS CUI [1])
Amantadine
Item
patients with previous amantadine use
boolean
C0002403 (UMLS CUI [1])
Immunossuppressive or antiviral treatment and drug intolerance
Item
systemic immunosuppressive or antiviral treatment during the last 24 weeks and those with a history of interferon and/or ribavirin intolerance
boolean
C0021079 (UMLS CUI [1])
C2363964 (UMLS CUI [2])
C0277585 (UMLS CUI [3])
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