Informações:
Falhas:
ID
14077
Descrição
Trial of Obeticholic Acid in Patients With Moderately Severe Alcoholic Hepatitis (AH); ODM derived from: https://clinicaltrials.gov/show/NCT02039219
Link
https://clinicaltrials.gov/show/NCT02039219
Palavras-chave
Versões (1)
- 27/03/2016 27/03/2016 -
Transferido a
27 de março de 2016
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Alcoholic Hepatitis NCT02039219
Eligibility Alcoholic Hepatitis NCT02039219
- StudyEvent: Eligibility
Similar models
Eligibility Alcoholic Hepatitis NCT02039219
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
acute alcoholic hepatitis
Item
individuals ≥ 21 years with a diagnosis of acute ah. the diagnosis of acute alcoholic hepatitis will be based on clinical features and testing including hepatomegaly, jaundice, fever, leukocytosis, compatible liver biochemistries in the context of heavy alcohol consumption. a liver biopsy is not mandatory, but will be required to confirm the diagnosis if a firm diagnosis of ah cannot be made on clinical and laboratory criteria
boolean
C0001306 (UMLS CUI [1])
meld score
Item
moderate severity defined as meld score > 11 and < 19
boolean
C1718072 (UMLS CUI [1])
heavy alcohol consumption
Item
heavy alcohol consumption (defined as > 40 grams per day on average in women and > 60 grams per day on average in men for a minimum of 6 months and within the 6 weeks prior to study enrollment)
boolean
C2030272 (UMLS CUI [1])
Written informed consent
Item
Written informed consent
boolean
C0021430 (UMLS CUI [1])
urine pregnancy test
Item
negative urine pregnancy test where appropriate
boolean
C0430057 (UMLS CUI [1])
ID.6
Item
women of child bearing potential should be willing to practice contraception throughout the treatment period
boolean
Infection
Item
significant active infection (e.g., sepsis, or spontaneous bacterial peritonitis; sbp). subjects can be reconsidered after the infection is under control.
boolean
C3714514 (UMLS CUI [1])
serum creatinine
Item
serum creatinine > 2.5 mg/dl
boolean
C0600061 (UMLS CUI [1])
systemic steroid therapy
Item
must not be receiving systemic steroids > 1 week at the time of screening or any experimental medicines for ah
boolean
C4039704 (UMLS CUI [1])
gastric bypass
Item
presence of any other disease or condition that is interfering with the absorption, distribution, metabolism, or excretion of drugs including bile salt metabolism in the intestine. patients who have undergone gastric bypass procedures will be excluded (gastric lap band is acceptable).
boolean
C0017125 (UMLS CUI [1])
investigational drug
Item
participation in another investigational drug, biologic, or medical device trial within 30 days prior to screening
boolean
C0013230 (UMLS CUI [1])