An open-label study of FPF1011 in patients with cerebrotendinous xanthomatosis (phase 3)
- Conditions
- Cerebrotendinous xanthomatosis
- Registration Number
- JPRN-jRCT2080225062
- Lead Sponsor
- Fujimoto Pharmaceutical Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 6
Main inclusion criteria.
1) The patient diagnosed with cerebrotendinous xanthomatosis.
2) Written informed consent.
3) In case of female patient of childbearing potential, the result of the pregnancy test (urine) conducted prior to registration must be negative, and she must consent to use suitable contraception not to get pregnant.
4) Outpatient.
Main exclusion criteria.
1) Patient who possibly changes the dosage and administration of restricted concomitant drugs or the usage of the restricted combination therapy.
2) Patient with the serious complications in circulation, respiratory, blood, liver, kidney, digestive system, and so on.
3) Patient with allergy to commercial CDCA formulations.
4) Breastfeeding woman.
5) Patient who has received any other investigational product or post-marketing clinical trial drug within 12 weeks prior to giving informed consent.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method