NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs031210156

Registered date:21/06/2021

Efficacy of Cholestimide in ATTRv Amyloidosis

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedATTR variant amyloidosis
Date of first enrollment21/06/2021
Target sample size10
Countries of recruitmentJapan
Study typeInterventional
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 OutcomeChange in the frequency of diarrhea before and after treatment
Secondary OutcomeChanges 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 maximumNot applicable
GenderBoth
Include criteria1) 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 criteriaPatients 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

Contact

Public contact
Name Mochizuki Yusuke
Address 3-1-1 Asahi, Matsumoto-shi, Nagano-ken, 390-8621, Japan Nagano Japan 390-8621
Telephone +81-263372673
E-mail sannai@shinshu-u.ac.jp
Affiliation Shinshu university department of medicine
Scientific contact
Name Sekijima Yoshiki
Address 3-1-1 Asahi, Matsumoto-shi, Nagano-ken, 390-8621, Japan Nagano Japan 390-8621
Telephone +81-263372673
E-mail sannai@shinshu-u.ac.jp
Affiliation Shinshu university department of medicine