Phase III study combined with post-marketing clinical study of RM1319 in patients with inborn error of bile acid metabolism, including childre

Phase 3

• Conditions: Inborn errors of bile acid metabolism

• Registration Number: JPRN-UMIN000041118
• Lead Sponsor: ReqMed Company, Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-07-15
• Study Completion: 2023-06-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

Not provided

Exclusion Criteria

Patients with any of the following criteria will be excluded from this study. 1. Among patients who have experienced hypersensitivity or serious side effects after administration of cholic acid or components contained in this investigational drug, patients who are determined to be unsuitable by the investigator or sub-investigator 2. Patients with galactose intolerance, Lapp lactase deficiency, or glucose/galactose malabsorption 3. Among patients with hypertriglyceridemia or family history, patients who are unable to confirm the effective dose even though they are administering a high dose of chenodeoxycholic acid 4. Patients who have participated in other clinical studies or clinical trials within the past 12 weeks 5. Patients with alcohol dependence or drug dependence 6. Pregnant or breast-feeding women. Among women of childbearing potential, who wish to become pregnant during this study or who cannot consent appropriate contraception (intrauterine contraceptive device/spermicide, wearing a condom by a partner, etc.) Check by urinary HCG test is mandatory at registration and specified timing during this study) 7. Other patients who are determined to be unsuitable by the investigator or sub-investigator

Study & Design

• Study Type: Interventional
• Study Design: Not specified