Efficacy of Cholestimide in ATTRv Amyloidosis

Phase 3

• Conditions: ATTR variant amyloidosis; amyloidosis, transthyretin; Amyloid Neuropathies, Familial

• Registration Number: JPRN-jRCTs031210156
• Lead Sponsor: Yoshiki Sekijima

Brief Summary

Increased production and secretion of bile acids are associated with diarrheal symptoms in patients with ATTRv amyloidosis. Cholestimide significantly reduces the frequency of diarrhea in patients with ATTRv amyloidosis. Further studies in larger cohorts are warranted.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-21
• Study Completion: 2023-01-16
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 9

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified