A pharmacokinetic study of sodium phenylbutyrate in refractory pediatric cholestasis disease
Phase 1
- Conditions
- Refractory pediatric cholestasis disease (progressive familial intrahepatic cholestasis, primary biliary cirrhosis, primary sclerosing cholangitis, Alagille syndrome, drug-induced cholestatic liver injury, biliary atresia, etc)
- Registration Number
- JPRN-UMIN000025037
- Lead Sponsor
- Juntendo University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 7
Inclusion Criteria
Not provided
Exclusion Criteria
1) Those who have hypersensitivity with phenylbutylate, its metabolites, drug additives and/or benzoate, etc 2) Subjects with congestive heart failure, kidney failure, and/or hypernatremia with edema 3) Subjects with renal dysfunction 4) Subjects with liver cirrhosis 5) Subjects who have been determined ineligible by principal investigator or sub-investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method