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Efficacy of Cholestimide in ATTRv Amyloidosis

Evaluation of Efficacy and Safety of Cholestimide for Diarrhea in Patients with ATTRv Amyloidosis

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs031210156
Enrollment
10
Registered
2021-06-21
Start date
2021-06-21
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ATTR variant amyloidosis amyloidosis, transthyretin

Interventions

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 leas

Sponsors

Yoshiki Sekijima
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

MeasureTime frame
Change in the frequency of diarrhea before and after treatment

Secondary

MeasureTime frame
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

Contacts

Public ContactMochizuki Yusuke

Shinshu university department of medicine

sannai@shinshu-u.ac.jp+81-263372673

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026