Tepurenone trial for HSCT

JRCT ID: jRCTs061210072

Registered date:27/01/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Hematological disease
• Date of first enrollment: 27/01/2022
• Target sample size: 80
• Study type: Interventional

Intervention(s)

Treated group: In addition to the conventional treatment, 50 mg of teprenone is administered after each meal for three weeks.
Non-treated group: Conventional treatment only

Outcome(s)

• Primary Outcome: Incidence of severe acute GVHD (Grade III or higher of acute GVHD)

Secondary Outcome

1) Survival rate at 100 days after transplantation
2) Factors that enable early prediction of acute GVHD severity.
3) Teprenone-induced changes in oxidative stress markers, including Trx-1 and HSP-70, and expression of pro-inflammatory cytokines

Key inclusion & exclusion criteria

• Age minimum: >= 15age old
• Age maximum: Not applicable
• Gender: Both
• Include criteria: Allogeneic hematopoietic stem cell transplant recipients

Exclude criteria

(1) Under 15 years old
(2) With mental illness or psychiatric symptoms
(3) Pregnancy, lactation
(4) Severe allergy to teprenone

Related Information

• Primary Sponsor: Fujii Keiko