ID

16020

Description

Gamma Interferon Therapy for Chronic Hepatitis C; ODM derived from: https://clinicaltrials.gov/show/NCT00028275

Lien

https://clinicaltrials.gov/show/NCT00028275

Mots-clés

Versions (1)
  1. 26/06/2016 26/06/2016 -
Téléchargé le

26 juin 2016

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Chronic Hepatitis C NCT00028275

Anglais

Eligibility Chronic Hepatitis C NCT00028275

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
age 18 years or above, male or female.
Description

age and gender

Type de données

boolean

Alias
UMLS CUI [1,1]
C0001779
UMLS CUI [1,2]
C0079399
serum alanine or asparate aminotransferase activities that are above the upper limit of normal (alt greater than 41 or ast greater than 31 iu/l).
Description

AST, ALT above limit

Type de données

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
presence of anti-hcv in serum.
Description

anti-hcv

Type de données

boolean

Alias
UMLS CUI [1]
C0201487
presence of hcv rna genotype1 in serum at levels above 10,000 copies/ml.
Description

hcv rna genotype1 level

Type de données

boolean

Alias
UMLS CUI [1]
C0369335
previous adequate therapy with alpha interferon and ribavirin without a sustained virological response. an adequate course of therapy is defined as at least 24 weeks of alpha interferon in starting doses of 3 million units thrice weekly and ribavirin in starting doses of at least 1000 mg daily. patients who initiated therapy at these doses, but required dose modification due to side effects will also be eligible.
Description

previous interferon-alpha or ribavirin therapy

Type de données

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0002199
UMLS CUI [2,1]
C1514463
UMLS CUI [2,2]
C0035525
written informed consent.
Description

written informed consent

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

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.
Description

decompensated liver disease

Type de données

boolean

Alias
UMLS CUI [1]
C0745744
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 spermacide, or birth control pills, or an intrauterine device.
Description

pregnancy and contraception

Type de données

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0700589
significant systemic or major illnesses other than liver disease, including congestive heart failure, ischemic heart disease, angina pectoris, cerebrovascular disease, renal failure (creatinine clearance less than 50 ml/min), organ transplantation, serious psychiatric disease or depression.
Description

comorbidity

Type de données

boolean

Alias
UMLS CUI [1]
C0009488
pre-existing, severe bone marrow compromise; anemia (hematocrit less than 34%), neutropenia (less than 1000 polymorphonuclear cells/mm(3)) or thrombocytopenia (less than 70,000 cells/mm(3)).
Description

bone marrow disease

Type de données

boolean

Alias
UMLS CUI [1]
C0005956
evidence of another form of liver disease in addition to viral hepatitis (for example autoimmune liver disease, wilson's disease, alcoholic liver disease, hemochromatosis, alpha-1-antitrypsin deficiency).
Description

liver disease

Type de données

boolean

Alias
UMLS CUI [1]
C0023895
active substance abuse, such as alcohol, inhaled or injection drugs within the previous six months.
Description

substance use disorder

Type de données

boolean

Alias
UMLS CUI [1]
C0038586
serious autoimmune disease that, in the opinion of the investigators, might be worsened by interferon therapy, such as lupus erythematous, rheumatoid arthritis or crohn's disease.
Description

serious autoimmune disease

Type de données

boolean

Alias
UMLS CUI [1]
C0004364
evidence of hepatocellular carcinoma; either alphafetoprotein (afp) levels greater than 50 ng/ml (normal less than 9 ng/ml) and/or ultrasound (or other imaging study) demonstrating a mass suggestive of liver cancer.
Description

evidence of hepatocellular carcinoma

Type de données

boolean

Alias
UMLS CUI [1]
C2239176
human immunodeficiency virus infection, as shown by presence of anti-hiv.
Description

HIV infection

Type de données

boolean

Alias
UMLS CUI [1]
C0019693
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Similar models

Eligibility Chronic Hepatitis C NCT00028275

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
age and gender
Item
age 18 years or above, male or female.
boolean
C0001779 (UMLS CUI [1,1])
C0079399 (UMLS CUI [1,2])
AST, ALT above limit
Item
serum alanine or asparate aminotransferase activities that are above the upper limit of normal (alt greater than 41 or ast greater than 31 iu/l).
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
anti-hcv
Item
presence of anti-hcv in serum.
boolean
C0201487 (UMLS CUI [1])
hcv rna genotype1 level
Item
presence of hcv rna genotype1 in serum at levels above 10,000 copies/ml.
boolean
C0369335 (UMLS CUI [1])
previous interferon-alpha or ribavirin therapy
Item
previous adequate therapy with alpha interferon and ribavirin without a sustained virological response. an adequate course of therapy is defined as at least 24 weeks of alpha interferon in starting doses of 3 million units thrice weekly and ribavirin in starting doses of at least 1000 mg daily. patients who initiated therapy at these doses, but required dose modification due to side effects will also be eligible.
boolean
C1514463 (UMLS CUI [1,1])
C0002199 (UMLS CUI [1,2])
C1514463 (UMLS CUI [2,1])
C0035525 (UMLS CUI [2,2])
written informed consent
Item
written informed consent.
boolean
C0021430 (UMLS CUI [1])
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
C0745744 (UMLS CUI [1])
pregnancy and 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 spermacide, or birth control pills, or an intrauterine device.
boolean
C0032961 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
comorbidity
Item
significant systemic or major illnesses other than liver disease, including congestive heart failure, ischemic heart disease, angina pectoris, cerebrovascular disease, renal failure (creatinine clearance less than 50 ml/min), organ transplantation, serious psychiatric disease or depression.
boolean
C0009488 (UMLS CUI [1])
bone marrow disease
Item
pre-existing, severe bone marrow compromise; anemia (hematocrit less than 34%), neutropenia (less than 1000 polymorphonuclear cells/mm(3)) or thrombocytopenia (less than 70,000 cells/mm(3)).
boolean
C0005956 (UMLS CUI [1])
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, alpha-1-antitrypsin deficiency).
boolean
C0023895 (UMLS CUI [1])
substance use disorder
Item
active substance abuse, such as alcohol, inhaled or injection drugs within the previous six months.
boolean
C0038586 (UMLS CUI [1])
serious autoimmune disease
Item
serious autoimmune disease that, in the opinion of the investigators, might be worsened by interferon therapy, such as lupus erythematous, rheumatoid arthritis or crohn's disease.
boolean
C0004364 (UMLS CUI [1])
evidence of hepatocellular carcinoma
Item
evidence of hepatocellular carcinoma; either alphafetoprotein (afp) levels greater than 50 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])
HIV infection
Item
human immunodeficiency virus infection, as shown by presence of anti-hiv.
boolean
C0019693 (UMLS CUI [1])
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