General Drug Use-Results survey of BESREMi

JRCT ID: jRCT2031240088

Registered date:16/05/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Patients with polycythemia vera (limited to cases where existing treatment is ineffective or inappro
• Date of first enrollment: 15/04/2024
• Target sample size: 200
• Study type: Observational

Outcome(s)

Primary Outcome

Safety issues
1. Severity and frequency of adverse events and side effects (including unknown events)
2. Adverse events and adverse reactions by patient background factors
3. Adverse events and adverse reactions by major organ category, serious adverse events and adverse reactions.

Secondary Outcome

Efficacy
1. Haematological complete response rate (CHR), CHR rate over time, CHR persistence rate
2. Molecular genetic response (MR) rate
3. Absolute values (frequency) of haematocrit, white blood cell count, platelet count and phlebotomy frequency from baseline
4. Change from baseline in absolute values (frequency) of haematocrit values, white blood cell counts, platelet counts and phlebotomy frequency
5. Change from baseline in JAK2 V617F allele verden values

Key inclusion & exclusion criteria

• Age minimum: >= 15age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Among patients with polycythemia vera (limited to cases where existing treatment is ineffective or inappropriate),
1. Patients who have agreed to participate in this study
2. Patients who have received Clozapine since the conclusion of the research agreement for this study.

• Exclude criteria: Patients with contraindications to administration in BESREMi package insert.

Related Information

• Primary Sponsor: PMS group R&D Div. PharmaEssentia Japan K.K.