A clinical study evaluating the effect of eppikajutsuto on lymphatic malformations

JRCT ID: jRCTs041210007

Registered date:16/04/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Lymphatic malformation
• Date of first enrollment: 12/08/2021
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Patients take the test drug "Eppikajutsuto" for 6 months. The dose is adjusted according to the body weight of the study subject, and 0.6 g / min 3 per kg of body weight per day is orally administered before meals. The amount of oral medication should be increased or decreased as the body weight is increased or decreased. The upper limit of medication is 7.5 g / day.

Outcome(s)

• Primary Outcome: The response of tumor volume due to volumetry of lymphatic malformation at 6 months after drug administration from before the start of administration, volume reduced by 20% at 6 months, and in the case of diffuse lesions, the reduction of major lesions are evaluated in the same manner.

Secondary Outcome

1. Ratio of volume reduced by 50% or more
2. Reduction rate of lesion
3. 10% improvement of QOL with treatment
4. Safety of administration of Eppikajutsuto
5. Medication adherence of Eppikajutsuto, Ratio of people who could take 70
% or more

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Diagunostic image (at least Echo,CT,MRI)demonstrates a specific LM lesion
2. Weight 25kg or less

Exclude criteria

When any one or more of the following items are satisfied
Has a history of allergic reactions to Eppikajutsuto.
Have received or have received mTOR inhibitors
Has undergone sclerotherapy / surgery in the past
Has a serious disease other than lymphatic malformation
Participated in other clinical studies (studies) within 3 months before the start of administration of the test drug
Evaluable MRI cannot be taken
When the principal investigator or the investigator determines that apatients is inappropriate for this study

Related Information

• Primary Sponsor: Ogawa Keiko
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development (AMED)