Hepatic encephalopathy
Conditions
Interventions
investigational material(s)
Generic name etc : Rifaximin
INN of investigational material : Rifaximin(INN)
Therapeutic category code : 619 Other antibiotic preparations (including mixed antibiotic prep
Sponsors
ASKA Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients should be eligible for the study if they meet all the following criteria: 1) Japanese pediatric patients aged under 18 when a consent form is obtained 2) Hyperammonemia (over 66 ug/dL of blood ammonia level) at enrollment 3) Grade I or II mental state of H.E. (Classification by ""criteria for pediatric HE"" or ""Inuyama Symposium"") at enrollment 4) Patient who has any of the following basic diseases. Hepatic cirrhosis, biliary atresia, portal hypertension (including Bunch syndrome), congenital absence of the portal vein (including portal-systemic shunt), Wilson disease, urea cycle disorder (chronic phase) and lysinuric protein intolerance 5) Obtained a consent from the legal representative (parents or legal gurdian) after sufficient study information is given to them. In addition, explain the study information as much as possible to the subject, when the principal investigator or coinvestigator concludes that the patient have ability to provide assent, the informed assent would be obtain from the pediatric subject.
Exclusion criteria
Exclusion criteria: Patients should be ineligible for the study if the patient meets either one of the following criteria 1) A concurrent disease or medical history (such as mental illness, metabolic disorders except Wilson disease, urea cycle disorder and lysinuric protein intolerance, chronic renal failure, hypertension, diabetes mellitus, hypoglycemia, myocardial infarction, cardiac failure, cerebral infarction, cerebro-degenerative disease, malignant tumor and Mycobacterium tuberculosis infection) of the patient is concluded by the principal investigator or coinvestigator that this may impact the study assessment. 2) Acute hepatitis or in the acute exacerbation phase of chronic hepatitis 3) Patients having either one of the following concurrent diseases Ascites requiring regular drainage Bleeding due to rupture of esophageal or gastric varicoses Spontaneous bacterial peritonitis Severe electrolyte abnormality that may impact the psychoneurological function 4) Laboratory values meet either one of the following levels at enrollment BUN over 25 mg/dL and serum creatinine over 2.0 mg/dL hemoglobin under 7 g/dL serum potassium under 2.5 mEq/L 5) Patients using an antibacterial agent (excluding a dermatological agent) either one of the following periods Within 6 days prior to the examinations of Blood ammonia level, Mental state, and Number connection test-A and test-B Within 1 week prior to the study medication 6) Unable to discontinue a drug prohibited for concomitant use in the study 7) Patients who proved impossible to administer the investigational drug for 2 weeks or more 8) Previous history of allergy to rifamycin antibiotics 9) Having received other investigational drugs within 16 weeks prior to the study medication 10) Patients who have difficulty taking tablets (10.2 mm in diameter) 11) Person in reproductive age and also are pregnant (possibly pregnant) or lactating or willing to become pregnant (including those who are unable to have appropriate contraception) 12) Other patients whom the principal investigator or coinvestigator concludes ineligible for the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy (blood ammonia level) pharmacokinetics safety - | — |
Secondary
| Measure | Time frame |
|---|---|
| other Mental state of H.E., Psychoneurological function test | — |
Countries
Japan
Contacts
Public ContactMasashi Tagawa
ASKA Pharmaceutical Co., Ltd.
Outcome results
None listed