Efficacy of Cholestimide in ATTRv Amyloidosis

JRCT ID: jRCTs031210156

Registered date:21/06/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: ATTR variant amyloidosis
• Date of first enrollment: 21/06/2021
• Target sample size: 10
• Study type: Interventional
• Intervention(s): At the time of diarrhea, cholestimide 500 mg given orally, three tablets twice daily before breakfast and dinner.The maximum daily dosage is 6 tablets, and the interval between doses should be at least 2 hours.

Outcome(s)

• Primary Outcome: Change in the frequency of diarrhea before and after treatment

Secondary Outcome

Changes in the following items before and after treatment.

1 Bristol Stool Form Scale
2 primary symptoms
3 Blood concentration of 7a-hydroxy-4-cholesten-3-one(C4)
4 mBMI
5 EQ-5D-5L

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Patients aged 20 years or older with a diagnosis of ATTRv amyloidosis
2) Patients with diarrhea symptoms that are difficult to control with existing symptomatic medications for diarrhea (Bristol Stool Shape Scale 6 or higher)
3) Patients who are able to comply with their medication and keep an appropriate diary.
4) Patients who have given written consent based on the free will of the subject after receiving sufficient explanation for participation in this study.

Exclude criteria

Patients who do not meet any of the following exclusion criteria will be included.
(1) Patients for whom consent cannot be obtained
(2) Patients who have contraindications to the use of the study drug (patients with complete obstruction of the biliary tract, patients with intestinal obstruction, patients with a history of hypersensitivity to the components of Corevine Tablets 500 mg).
(3) Other patients who are judged by the principal investigator to be unsuitable as subjects.

Related Information

• Primary Sponsor: Yoshiki Sekijima