ID

13700

Description

Hepatitis C Rimantadine and Antiviral Combination Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT01413490

Link

https://clinicaltrials.gov/show/NCT01413490

Keywords

Versions (1)
  1. 2/29/16 2/29/16 -
Uploaded on

February 29, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatitis C NCT01413490

English

Eligibility Hepatitis C NCT01413490

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
have a diagnosis of hcv infection, genotype 1 or genotype 3
Description

infection Hepatitis C; Genotype

Data type

boolean

Alias
UMLS CUI [1,1]
C3714514
UMLS CUI [1,2]
C0019196
be eligible for standard combination therapy with pegylated ifn and ribavirin
Description

combination therapy ribavirin

Data type

boolean

Alias
UMLS CUI [1,1]
C0013218
UMLS CUI [1,2]
C0035525
be at least 18 but no more than 65 years of age
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
have signed an informed consent indicating that the patient is aware of the infectious nature of their disease and have been informed of the procedures of the protocol, the experimental nature of the therapy, alternatives, potential benefits, side effects, risks, and discomforts
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
be willing and able to comply with scheduled visits, the treatment plan, and laboratory tests
Description

compliance

Data type

boolean

Alias
UMLS CUI [1]
C1321605
have no contraindications to receiving rimantadine therapy
Description

contraindication rimantadine

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0035629
have blood results within defined acceptable haematological and biochemical parameters (haemoglobin >10 g/dl, platelet count >150 x 109/l, bilirubin <25 umol/l, albumin >35 g/l, creatinine <150 umol/l
Description

haemoglobin; platelet count

Data type

boolean

Alias
UMLS CUI [1]
C0518015
UMLS CUI [2]
C0032181
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
have dementia or altered mental status that would prohibit informed consent
Description

Informed Consent Limited Comorbidity

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
have previously received treatment for hcv infection (i.e. are currently treatment naïve)
Description

therapy hepatitis c

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0019196
have any condition which would deem the patient ineligible for combination therapy with pegylated ifn or ribavirin. this includes pregnancy, significant cardiac, renal or autoimmune disease, severe depression or psychosis, and previous organ transplantation
Description

comorbidity affecting treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0087111
cirrhosis or liver failure as evidenced by clinical (cutaneous stigmata of chronic liver disease, ascites, encephalopathy), ultrasonic (cirrhotic appearance of liver, ascites) or biochemical (platelet count >150 x 109/l, bilirubin <25 umol/l, albumin >35 g/l) evidence, routinely collated in all patients diagnosed with hcv
Description

cirrhosis; liver failure; encephalopathy

Data type

boolean

Alias
UMLS CUI [1]
C0023890
UMLS CUI [2]
C0085605
UMLS CUI [3]
C0085584
any condition which would preclude the use of rimantadine. this comprises significant renal impairment (creatinine >150), pregnancy, epilepsy or history of unexplained seizures
Description

rimantadine; epilepsy; Renal Insufficiency

Data type

boolean

Alias
UMLS CUI [1]
C0035629
UMLS CUI [2]
C0014544
UMLS CUI [3]
C1565489
have any other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the chief investigators, would make the patient inappropriate for this study. this includes the presence of end stage liver disease (cirrhosis), and hiv infection
Description

Compliance behavior Limited Comorbidity

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
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Similar models

Eligibility Hepatitis C NCT01413490

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
infection Hepatitis C; Genotype
Item
have a diagnosis of hcv infection, genotype 1 or genotype 3
boolean
C3714514 (UMLS CUI [1,1])
C0019196 (UMLS CUI [1,2])
combination therapy ribavirin
Item
be eligible for standard combination therapy with pegylated ifn and ribavirin
boolean
C0013218 (UMLS CUI [1,1])
C0035525 (UMLS CUI [1,2])
age
Item
be at least 18 but no more than 65 years of age
boolean
C0001779 (UMLS CUI [1])
informed consent
Item
have signed an informed consent indicating that the patient is aware of the infectious nature of their disease and have been informed of the procedures of the protocol, the experimental nature of the therapy, alternatives, potential benefits, side effects, risks, and discomforts
boolean
C0021430 (UMLS CUI [1])
compliance
Item
be willing and able to comply with scheduled visits, the treatment plan, and laboratory tests
boolean
C1321605 (UMLS CUI [1])
contraindication rimantadine
Item
have no contraindications to receiving rimantadine therapy
boolean
C1301624 (UMLS CUI [1,1])
C0035629 (UMLS CUI [1,2])
haemoglobin; platelet count
Item
have blood results within defined acceptable haematological and biochemical parameters (haemoglobin >10 g/dl, platelet count >150 x 109/l, bilirubin <25 umol/l, albumin >35 g/l, creatinine <150 umol/l
boolean
C0518015 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Informed Consent Limited Comorbidity
Item
have dementia or altered mental status that would prohibit informed consent
boolean
C0021430 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
therapy hepatitis c
Item
have previously received treatment for hcv infection (i.e. are currently treatment naïve)
boolean
C0087111 (UMLS CUI [1,1])
C0019196 (UMLS CUI [1,2])
comorbidity affecting treatment
Item
have any condition which would deem the patient ineligible for combination therapy with pegylated ifn or ribavirin. this includes pregnancy, significant cardiac, renal or autoimmune disease, severe depression or psychosis, and previous organ transplantation
boolean
C0009488 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
cirrhosis; liver failure; encephalopathy
Item
cirrhosis or liver failure as evidenced by clinical (cutaneous stigmata of chronic liver disease, ascites, encephalopathy), ultrasonic (cirrhotic appearance of liver, ascites) or biochemical (platelet count >150 x 109/l, bilirubin <25 umol/l, albumin >35 g/l) evidence, routinely collated in all patients diagnosed with hcv
boolean
C0023890 (UMLS CUI [1])
C0085605 (UMLS CUI [2])
C0085584 (UMLS CUI [3])
rimantadine; epilepsy; Renal Insufficiency
Item
any condition which would preclude the use of rimantadine. this comprises significant renal impairment (creatinine >150), pregnancy, epilepsy or history of unexplained seizures
boolean
C0035629 (UMLS CUI [1])
C0014544 (UMLS CUI [2])
C1565489 (UMLS CUI [3])
Compliance behavior Limited Comorbidity
Item
have any other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the chief investigators, would make the patient inappropriate for this study. this includes the presence of end stage liver disease (cirrhosis), and hiv infection
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
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