ID

44001

Beschreibung

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

Link

https://clinicaltrials.gov/show/NCT00029107

Stichworte

Versionen (2)
  1. 08.07.16 08.07.16 -
  2. 20.09.21 20.09.21 -
Hochgeladen am

20. September 2021

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Hepatitis C NCT00029107

Englisch

Eligibility Hepatitis C NCT00029107

1 Formulare  
Criteria
Beschreibung

Criteria

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

diagnosis of hcv-cv

Datentyp

boolean

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

hcv rna- or seropositive

Datentyp

boolean

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

active vasculitis

Datentyp

boolean

Alias
UMLS CUI [1]
C0042384
palpable purpura
Beschreibung

palpable purpura

Datentyp

boolean

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

glomerulonephritis

Datentyp

boolean

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

acute peripheral neuropathy

Datentyp

boolean

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

detectable cryoglobulins or rheumatoid factors

Datentyp

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.
Beschreibung

cytostatic treatment failure

Datentyp

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.
Beschreibung

personal physician

Datentyp

boolean

ages of 18 and 75 years
Beschreibung

age

Datentyp

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.
Beschreibung

contraceptive methods

Datentyp

boolean

Alias
UMLS CUI [1]
C0700589
Exclusion Criteria
Beschreibung

Exclusion Criteria

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

immunosuppressive therapy

Datentyp

boolean

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

active systemic infection

Datentyp

boolean

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

pregnancy or breast feeding

Datentyp

boolean

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

prior treatment with rituximab

Datentyp

boolean

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

allergy to murine proteins

Datentyp

boolean

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

renal insufficiency

Datentyp

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).
Beschreibung

life-threatening hcv-cv

Datentyp

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.
Beschreibung

hepatic insufficiency

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1306571
UMLS CUI [1,2]
C4050412
history of variceal bleeding, encephalopathy.
Beschreibung

variceal bleeding or encephalopathy

Datentyp

boolean

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

history of liver transplantation.

Datentyp

boolean

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

co-infection with either hbv or hiv

Datentyp

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.
Beschreibung

any condition compromising study protocol compliance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
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Ähnliche Modelle

Eligibility Hepatitis C NCT00029107

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
C4050412 (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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