ID

16443

Beskrivning

Pegylated Interferon to Treat Chronic Hepatitis D; ODM derived from: https://clinicaltrials.gov/show/NCT00023322

Länk

https://clinicaltrials.gov/show/NCT00023322

Nyckelord

Versioner (1)
  1. 2016-07-16 2016-07-16 -
Uppladdad den

16 juli 2016

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Hepatitis D NCT00023322

Engelsk

Eligibility Hepatitis D NCT00023322

1 Formulär  
Criteria
Beskrivning

Criteria

age greater than or equal to 18 years, male or female
Beskrivning

age greater than or equal to 18 years, male or female

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
serum alanine or aspartate aminotransferase activities that are above the upper limit of normal (alt greater than 41 or ast greater than 31 u/l) on an average of three determinations taken during the previous 6 months. the mean of the three determinations will be defined as 'baseline' levels.
Beskrivning

ALT and AST measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0201836
UMLS CUI [2]
C0201899
presence of anti-hdv in serum
Beskrivning

presence of anti-hdv in serum

Datatyp

boolean

Alias
UMLS CUI [1]
C0312635
evidence of chronic hepatitis on liver biopsy done within the previous 12 months with a necroinflammatory score in histology activity index of at least 5 (out of a maximum of 18) and at least 1 for hepatic fibrosis (out of a maximum of 6).
Beskrivning

chronic hepatitis and necroinflammatory score

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0019189
UMLS CUI [1,2]
C1954431
presence of hdv antigen in liver tissue.
Beskrivning

presence of hdv antigen in liver tissue

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0525569
UMLS CUI [1,2]
C0736268
written informed consent.
Beskrivning

written informed consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
previous standard alpha interferon or other antiviral activity will not exclude patients.
Beskrivning

previous standard alpha interferon or other antiviral activity

Datatyp

boolean

Alias
UMLS CUI [1]
C0278953
UMLS CUI [2,1]
C1514463
UMLS CUI [2,2]
C0280274
active hbv replication will not exclude patients.
Beskrivning

active hbv replication

Datatyp

boolean

all ethnicities.
Beskrivning

all ethnicities

Datatyp

boolean

patients will need to meet the first six entry criteria to enroll
Beskrivning

patients will need to meet the first six entry criteria to enroll

Datatyp

boolean

Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
decompensated liver disease, as marked by bilirubin greater than 4 mg%, albumin less than 3.0 gm%, prothrombin time greater than 2 sec prolonged, or history of bleeding esophageal varices, ascites or hepatic encephalopathy. patients with alt levels greater than 1000 u/l (greater than 25 times uln) will not be enrolled but may be followed until three determinations are below this level.
Beskrivning

decompensated liver disease

Datatyp

boolean

Alias
UMLS CUI [1]
C4075847
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201838
UMLS CUI [4]
C0033707
UMLS CUI [5]
C0201836
pregnancy or, in women of child-bearing potential or in spouses of such women, inability to practice adequate contraception defined as vasectomy in men, tubal ligation in women, or use of condoms and spermicide, or birth control pills, or an intrauterine device, or depo-provera, or norplant.
Beskrivning

pregnancy or adequate contraception

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0700589
significant systemic or major illnesses other than liver disease, including, but not limited to, congestive heart failure, renal failure (creatinine clearance less than 50 ml/min), organ transplantation, serious psychiatric disease or depression (only if felt to be at high risk by the nih psychiatric consultation service), and angina pectoris.
Beskrivning

comorbidities

Datatyp

boolean

Alias
UMLS CUI [1]
C0009488
immunosuppressive therapy within the last 6 months.
Beskrivning

immunosuppressive therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0021079
evidence of another form of liver disease in addition to viral hepatitis (for example autoimmune liver disease, wilson's disease, alcoholic liver disease, hemochromatosis, and alpha-1-antitrypsin deficiency).
Beskrivning

other liver disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0023895
any evidence of coronary artery disease or cerebral vascular disease, including abnormalities on exercise stress testing in patients with defined risk factors who will be screened for evidence of underlying coronary artery disease.
Beskrivning

coronary artery disease or cerebral vascular disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0010068
UMLS CUI [2]
C0007820
active substance abuse, such as alcohol, inhaled or injection drugs within the previous year.
Beskrivning

active substance use disorder

Datatyp

boolean

Alias
UMLS CUI [1]
C0038586
evidence of hepatocellular carcinoma; either alphafetoprotein (afp) levels greater than 200 ng/ml (normal less than 9 ng/ml) and/or ultrasound (or other imaging study) demonstrating a mass suggestive of liver cancer.
Beskrivning

evidence of hepatocellular carcinoma

Datatyp

boolean

Alias
UMLS CUI [1]
C2239176
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Similar models

Eligibility Hepatitis D NCT00023322

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
age greater than or equal to 18 years, male or female
Item
age greater than or equal to 18 years, male or female
boolean
C0001779 (UMLS CUI [1])
ALT and AST measurement
Item
serum alanine or aspartate aminotransferase activities that are above the upper limit of normal (alt greater than 41 or ast greater than 31 u/l) on an average of three determinations taken during the previous 6 months. the mean of the three determinations will be defined as 'baseline' levels.
boolean
C0201836 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
presence of anti-hdv in serum
Item
presence of anti-hdv in serum
boolean
C0312635 (UMLS CUI [1])
chronic hepatitis and necroinflammatory score
Item
evidence of chronic hepatitis on liver biopsy done within the previous 12 months with a necroinflammatory score in histology activity index of at least 5 (out of a maximum of 18) and at least 1 for hepatic fibrosis (out of a maximum of 6).
boolean
C0019189 (UMLS CUI [1,1])
C1954431 (UMLS CUI [1,2])
presence of hdv antigen in liver tissue
Item
presence of hdv antigen in liver tissue.
boolean
C0525569 (UMLS CUI [1,1])
C0736268 (UMLS CUI [1,2])
written informed consent
Item
written informed consent.
boolean
C0021430 (UMLS CUI [1])
previous standard alpha interferon or other antiviral activity
Item
previous standard alpha interferon or other antiviral activity will not exclude patients.
boolean
C0278953 (UMLS CUI [1])
C1514463 (UMLS CUI [2,1])
C0280274 (UMLS CUI [2,2])
active hbv replication
Item
active hbv replication will not exclude patients.
boolean
all ethnicities
Item
all ethnicities.
boolean
patients will need to meet the first six entry criteria to enroll
Item
patients will need to meet the first six entry criteria to enroll
boolean
Item Group
C0680251 (UMLS CUI)
decompensated liver disease
Item
decompensated liver disease, as marked by bilirubin greater than 4 mg%, albumin less than 3.0 gm%, prothrombin time greater than 2 sec prolonged, or history of bleeding esophageal varices, ascites or hepatic encephalopathy. patients with alt levels greater than 1000 u/l (greater than 25 times uln) will not be enrolled but may be followed until three determinations are below this level.
boolean
C4075847 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201838 (UMLS CUI [3])
C0033707 (UMLS CUI [4])
C0201836 (UMLS CUI [5])
pregnancy or adequate contraception
Item
pregnancy or, in women of child-bearing potential or in spouses of such women, inability to practice adequate contraception defined as vasectomy in men, tubal ligation in women, or use of condoms and spermicide, or birth control pills, or an intrauterine device, or depo-provera, or norplant.
boolean
C0032961 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
comorbidities
Item
significant systemic or major illnesses other than liver disease, including, but not limited to, congestive heart failure, renal failure (creatinine clearance less than 50 ml/min), organ transplantation, serious psychiatric disease or depression (only if felt to be at high risk by the nih psychiatric consultation service), and angina pectoris.
boolean
C0009488 (UMLS CUI [1])
immunosuppressive therapy
Item
immunosuppressive therapy within the last 6 months.
boolean
C0021079 (UMLS CUI [1])
other liver disease
Item
evidence of another form of liver disease in addition to viral hepatitis (for example autoimmune liver disease, wilson's disease, alcoholic liver disease, hemochromatosis, and alpha-1-antitrypsin deficiency).
boolean
C0023895 (UMLS CUI [1])
coronary artery disease or cerebral vascular disease
Item
any evidence of coronary artery disease or cerebral vascular disease, including abnormalities on exercise stress testing in patients with defined risk factors who will be screened for evidence of underlying coronary artery disease.
boolean
C0010068 (UMLS CUI [1])
C0007820 (UMLS CUI [2])
active substance use disorder
Item
active substance abuse, such as alcohol, inhaled or injection drugs within the previous year.
boolean
C0038586 (UMLS CUI [1])
evidence of hepatocellular carcinoma
Item
evidence of hepatocellular carcinoma; either alphafetoprotein (afp) levels greater than 200 ng/ml (normal less than 9 ng/ml) and/or ultrasound (or other imaging study) demonstrating a mass suggestive of liver cancer.
boolean
C2239176 (UMLS CUI [1])
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