ID

16278

Description

Rituximab to Treat Hepatitis C-Associated Cryoglobulinemic Vasculitis; ODM derived from: https://clinicaltrials.gov/show/NCT00029107

Link

https://clinicaltrials.gov/show/NCT00029107

Keywords

Versions (2)
  1. 7/8/16 7/8/16 -
  2. 9/20/21 9/20/21 -
Uploaded on

July 8, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatitis C NCT00029107

English

Eligibility Hepatitis C NCT00029107

1 forms  
Criteria
Description

Criteria

diagnosis of hcv-cv: must have all of the following
Description

diagnosis of hcv-cv

Data type

boolean

Alias
UMLS CUI [1]
C0019196
hcv infection documented by serology and/or plasma hcv rna.
Description

hcv rna- or seropositive

Data type

boolean

Alias
UMLS CUI [1]
C1269695
UMLS CUI [2]
C0855842
one or more organ system with objective evidence of active vasculitis such as:
Description

active vasculitis

Data type

boolean

Alias
UMLS CUI [1]
C0042384
palpable purpura
Description

palpable purpura

Data type

boolean

Alias
UMLS CUI [1]
C0151190
glomerulonephritis (defined by the presence of glomerular hematuria and/or new or worsening proteinuria);
Description

glomerulonephritis

Data type

boolean

Alias
UMLS CUI [1]
C0017658
acute peripheral neuropathy.
Description

acute peripheral neuropathy

Data type

boolean

Alias
UMLS CUI [1]
C0031117
detectable cryoglobulins and/or rf.
Description

detectable cryoglobulins or rheumatoid factors

Data type

boolean

Alias
UMLS CUI [1]
C0392385
UMLS CUI [2]
C0151379
failure of treatment with ifn-alpha and ribavirin to control manifestations of hcv-cv or intolerance to ifn-alpha/ribavirin regimen.
Description

cytostatic treatment failure

Data type

boolean

Alias
UMLS CUI [1,1]
C0162643
UMLS CUI [1,2]
C0002199
UMLS CUI [2,1]
C0162643
UMLS CUI [2,2]
C0035525
patients must have a personal physician responsible for the care of their hcv.
Description

personal physician

Data type

boolean

ages of 18 and 75 years
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
willingness to use effective contraception during and for 12 months following rituximab treatment. effective contraception methods include abstinence, surgical sterilization of either partner, barrier methods such as diaphragm, condom, cap or sponge, or hormonal contraception.
Description

contraceptive methods

Data type

boolean

Alias
UMLS CUI [1]
C0700589
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
recent (within 4 weeks) initiation of or increase in immunosuppressive therapy.
Description

immunosuppressive therapy

Data type

boolean

Alias
UMLS CUI [1]
C0021079
active systemic infection (other than hepatitis c).
Description

active systemic infection

Data type

boolean

Alias
UMLS CUI [1]
C0009450
pregnancy or breast feeding.
Description

pregnancy or breast feeding

Data type

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0006147
prior treatment with rituximab.
Description

prior treatment with rituximab

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0393022
known allergy to murine proteins.
Description

allergy to murine proteins

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1699668
significant renal insufficiency (creatinine clearance less than 30 ml/min).
Description

renal insufficiency

Data type

boolean

Alias
UMLS CUI [1]
C1565489
presence of life-threatening hcv-cv; defined as rapidly progressive glomerulonephritis (defined as a doubling of the serum creatinine over a 3 month period), cns vasculitis, cardiac disease due to active vasculitis, or gi vasculitis (defined by ischemic bowel, perforation, or infarction).
Description

life-threatening hcv-cv

Data type

boolean

Alias
UMLS CUI [1]
C0221239
UMLS CUI [2]
C0042384
UMLS CUI [3]
C0856069
significant hepatic insufficiency as manifested by child-pugh classification of b or c.
Description

hepatic insufficiency

Data type

boolean

Alias
UMLS CUI [1,1]
C1306571
UMLS CUI [1,2]
C2347612
history of variceal bleeding, encephalopathy.
Description

variceal bleeding or encephalopathy

Data type

boolean

Alias
UMLS CUI [1]
C1739112
UMLS CUI [2]
C0085584
history of liver transplantation.
Description

history of liver transplantation.

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0023911
co-infection with either hbv or hiv.
Description

co-infection with either hbv or hiv

Data type

boolean

Alias
UMLS CUI [1]
C2242656
UMLS CUI [2]
C4062778
any underlying medical condition that in the judgment of the investigator would put the patient at increased risk for serious infusion-related adverse events.
Description

any condition compromising study protocol compliance

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 NCT00029107

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
diagnosis of hcv-cv
Item
diagnosis of hcv-cv: must have all of the following
boolean
C0019196 (UMLS CUI [1])
hcv rna- or seropositive
Item
hcv infection documented by serology and/or plasma hcv rna.
boolean
C1269695 (UMLS CUI [1])
C0855842 (UMLS CUI [2])
active vasculitis
Item
one or more organ system with objective evidence of active vasculitis such as:
boolean
C0042384 (UMLS CUI [1])
palpable purpura
Item
palpable purpura
boolean
C0151190 (UMLS CUI [1])
glomerulonephritis
Item
glomerulonephritis (defined by the presence of glomerular hematuria and/or new or worsening proteinuria);
boolean
C0017658 (UMLS CUI [1])
acute peripheral neuropathy
Item
acute peripheral neuropathy.
boolean
C0031117 (UMLS CUI [1])
detectable cryoglobulins or rheumatoid factors
Item
detectable cryoglobulins and/or rf.
boolean
C0392385 (UMLS CUI [1])
C0151379 (UMLS CUI [2])
cytostatic treatment failure
Item
failure of treatment with ifn-alpha and ribavirin to control manifestations of hcv-cv or intolerance to ifn-alpha/ribavirin regimen.
boolean
C0162643 (UMLS CUI [1,1])
C0002199 (UMLS CUI [1,2])
C0162643 (UMLS CUI [2,1])
C0035525 (UMLS CUI [2,2])
personal physician
Item
patients must have a personal physician responsible for the care of their hcv.
boolean
age
Item
ages of 18 and 75 years
boolean
C0001779 (UMLS CUI [1])
contraceptive methods
Item
willingness to use effective contraception during and for 12 months following rituximab treatment. effective contraception methods include abstinence, surgical sterilization of either partner, barrier methods such as diaphragm, condom, cap or sponge, or hormonal contraception.
boolean
C0700589 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
immunosuppressive therapy
Item
recent (within 4 weeks) initiation of or increase in immunosuppressive therapy.
boolean
C0021079 (UMLS CUI [1])
active systemic infection
Item
active systemic infection (other than hepatitis c).
boolean
C0009450 (UMLS CUI [1])
pregnancy or breast feeding
Item
pregnancy or breast feeding.
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
prior treatment with rituximab
Item
prior treatment with rituximab.
boolean
C1514463 (UMLS CUI [1,1])
C0393022 (UMLS CUI [1,2])
allergy to murine proteins
Item
known allergy to murine proteins.
boolean
C0020517 (UMLS CUI [1,1])
C1699668 (UMLS CUI [1,2])
renal insufficiency
Item
significant renal insufficiency (creatinine clearance less than 30 ml/min).
boolean
C1565489 (UMLS CUI [1])
life-threatening hcv-cv
Item
presence of life-threatening hcv-cv; defined as rapidly progressive glomerulonephritis (defined as a doubling of the serum creatinine over a 3 month period), cns vasculitis, cardiac disease due to active vasculitis, or gi vasculitis (defined by ischemic bowel, perforation, or infarction).
boolean
C0221239 (UMLS CUI [1])
C0042384 (UMLS CUI [2])
C0856069 (UMLS CUI [3])
hepatic insufficiency
Item
significant hepatic insufficiency as manifested by child-pugh classification of b or c.
boolean
C1306571 (UMLS CUI [1,1])
C2347612 (UMLS CUI [1,2])
variceal bleeding or encephalopathy
Item
history of variceal bleeding, encephalopathy.
boolean
C1739112 (UMLS CUI [1])
C0085584 (UMLS CUI [2])
history of liver transplantation.
Item
history of liver transplantation.
boolean
C0262926 (UMLS CUI [1,1])
C0023911 (UMLS CUI [1,2])
co-infection with either hbv or hiv
Item
co-infection with either hbv or hiv.
boolean
C2242656 (UMLS CUI [1])
C4062778 (UMLS CUI [2])
any condition compromising study protocol compliance
Item
any underlying medical condition that in the judgment of the investigator would put the patient at increased risk for serious infusion-related adverse events.
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
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