The multicenter continuous clinical study on the safety of long-term administration of bezafibrate for mitochondrial fatty acid beta-oxidation disorders

The multicenter continuous clinical study on the safety of long-term administration of bezafibrate for mitochondrial fatty acid beta-oxidation disorders - BezFAOD continuous clinical study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000017984

Enrollment

Registered

2015-07-02

Start date

2015-08-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

mitochondrial fatty acid beta-oxidation disorders

Interventions

Administer orally the following daily doses, which are equivalent to the end of the preceding study (HUPE-002-02), of the investigational drug twice a day after breakfast and dinner. (1) for ages 3

Standard treatment period: 200mg (morning: 100mg, evening: 100mg) When dose increased: 300mg (morning: 200mg, evening: 100mg) (2) for ages 7.5 to 11

Standard treatment period: 300mg (morning: 200mg, evening: 100mg) When dose increased: 400mg (morning: 200mg, evening: 200mg) (3) for ages 12 and older

Standard treatment period: 600mg (morning: 300mg, evening: 300mg) When dose increased: 800mg (morning: 400mg, evening: 400mg)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patient who: (1) was enrolled in the preceding study (HUPE-002-02) and completed Week 78 (2) gives written informed consent before enrolling the study. The consent from a legally acceptable representative is required for the patients with uncertain capacity of judgments. Subjective patients under 20-year-old should receive an adequate explanation depending on one's ability to understand, and give assent with written forms if possible

Exclusion criteria

Exclusion criteria: Patient who is considered ineligible for enrolling the study by a principal investigator or sub-investigator

Design outcomes

Primary

Measure	Time frame
Safety endpoint Existence and its contents of adverse events and side effects	—

Countries

Japan

Contacts

Public ContactSaki Yokoshiki

Hokkaido University Hospital Clinical Research and Medical innovation Center Research and Development Division

Beza@pop.med.hokudai.ac.jp011-706-7735

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026