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A study of efficacy and safety of 5-aminolevulinic acid phosphate in patients with sideroblastic anemia

A study of efficacy and safety of 5-aminolevulinic acid phosphate in patients with sideroblastic anemia - Efficacy and safety of 5-ALA phosphate in patients with sideroblastic anemia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000021407
Enrollment
5
Registered
2016-03-15
Start date
2016-03-15
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

sideroblastic anemia

Interventions

Orally intake a 150 mg 5-aminolevulinic acid phosphate capsule once a day for up to 24 weeks.

Sponsors

Department of Hematology and Oncology, Graduate School of Medicine, Kyoto University
Lead Sponsor
SBI Pharmaceuticals Co., Ltd
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Individuals with sideroblastic anemia willing to give written informed consent for study participation

Exclusion criteria

Exclusion criteria: Platelet count less than 100,000/micro L. Neutrophil count less than 1500/micro L.

Design outcomes

Primary

MeasureTime frame
Efficacy (improvement of the hemoglobin value) at 12 weeks after the initiation of the treatment.

Secondary

MeasureTime frame
Safety until 8 weeks after the discontinuation of the treatment.

Countries

Japan

Contacts

Public ContactHiroshi Kawabata

Graduate School of Medicine, Kyoto University Department of Hematology and Oncology

hkawabat@kuhp.kyoto-u.ac.jp075-751-4964

Outcome results

None listed

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