Efficacy and safety of apraglutide in SBS-IF

JRCT ID: jRCT2021210005

Registered date:10/05/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: short bowel syndrome and intestinal failure (SBS-IF)
• Date of first enrollment: 04/08/2021
• Target sample size: 12
• Countries of recruitment: Argentina,Japan,Belgium,Japan,Czech Republic,Japan,Denmark,Japan,France,Japan,Germany,Japan,Israel,Japan,Italy,Japan,Norway,Japan,Poland,Japan,Korea,Japan,Spain,Japan,Sweden,Japan,Taiwan,Japan,United Kingdom,Japan,United States,Japan
• Study type: Interventional
• Intervention(s): Apraglutide 2.5 mg or 5 mg SC once weekly

Outcome(s)

Primary Outcome

Relative change from baseline in actual weekly PS
volume at Week 24

Secondary Outcome

- Subjects who achieve a reduction of at least 1 day per week of PS from baseline at Week 24
- Relative change from baseline in actual weekly PS volume at Week 24 in stoma subjects
- Subjects who achieve a reduction of at least 1 day per week of PS from baseline at Week 48 in CIC
subjects.
- CIC subjects reaching enteral autonomy at Week 48

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Male and female subjects with SBS-IF, receiving PS,
secondary to surgical resection of the small intestine
with <200 cm from duodeno-jejunal flexure, based on
available medical/surgical records and with either:
a. CIC and neither jejunostomy nor ileostomy with
the latest intestinal resection being at least
12 months prior to screening OR
b. Jejunostomy or ileostomy with the latest
intestinal resection being at least 6 months
prior to screening.

Exclude criteria

Major abdominal surgery (more than 10% intestinal
resection or surgery that changes anatomy group) in
the last 6 months prior to screening. Surgery for
feeding tube placement allowed.

Related Information

• Primary Sponsor: Kashiyama Akinori
• Secondary ID(s): NCT04627025