A Study of Teduglutide in Japanese People with Short Bowel Syndrome

JRCT ID: jRCT2031210284

Registered date:27/08/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Short Bowel Syndrome
• Date of first enrollment: 01/09/2021
• Target sample size: 120
• Study type: Observational

Outcome(s)

Primary Outcome

1.Number of Participants with Adverse Events
Timeframe: Up to 36 months
An adverse event (AE) is any untoward or undesirable medical occurrence in a participant linked in time with the use of a pharmaceutical/ medicinal product. They are not limited to the events with clear causal relationship with treatment with concerned drug. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.

2.Number of Participants with Serious Adverse Events
Timeframe: Up to 30 days
A serious AE is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability /incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria.

Secondary Outcome

1.Changes from Baseline in Prescription Volume of Parenteral Nutrition Intravenous (PN/IV) Support
Time Frame: Baseline, 6, 12, 18, 24, 30, and 36 months after teduglutide treatment initiation
Changes from baseline in prescription volume ofPN/IV support prescribed by investigators to 6, 12, 18, 24, 30, and 36 months after teduglutide treatment initiation will be reported.

2.Percent Change from Baseline in Prescription Volume of PN/IV Support
Time Frame: Baseline, 6, 12, 18, 24, 30, and 36 months after teduglutide treatment initiation
Percent change from baseline in prescription volume of PN/IV support to multiple timepoints (6, 12, 18, 24, 30, and 36 months) after teduglutide treatment initiation will be reported. Percent change from baseline will be calculated as following; [prescription volume at each timepoint - prescription volume at baseline] / prescription volume at baseline * 100 (percent).

3.Changes from Baseline in Dose of PN/IV Support
Time Frame: Baseline, 6, 12, 18, 24, 30, and 36 months after teduglutide treatment initiation
Changes from baseline in actual dose of PN/IV support to 6, 12, 18, 24, 30, and 36 months after teduglutide treatment initiation will be reported.

4.Percent Change from Baseline of Dose in PPN/IV Support
Time Frame: Baseline, 6, 12, 18, 24, 30, and 36 months after teduglutide treatment initiation
Percent change from baseline in actual dose of PN/IV support to multiple timepoints (6, 12, 18, 24, 30, and 36 months) after teduglutide treatment initiation will be reported. Percent change from baseline will be calculated as following; [actual dose at each timepoint - actual dose at baseline] / actual dose at baseline * 100 (percent).

5.Percentage of Participants who Completely Wean off PN/IV Support
Time Frame: Baseline, 6, 12, 18, 24, 30, and 36 months after teduglutide treatment initiation
Number of participants who completely wean off PN/IV support will be assessed.

6.Crohn's Disease Activity Index (CDAI)
Time Frame: 36 months after teduglutide treatment initiation
CDAI score is calculated from the following 8 items: (a) Number of liquid or very soft stools; (b) Abdominal pain; (c) General wellbeing; (d) Extraintestinal complications; (e) Antidiarrhoeal drugs; (f) Abdominal mass; (g) Hematocrit; and (h) Body weight. Scores of some items in CDAI are calculated based on patient diary. Total range of score is more than 0. Higher score means more severe disease and especially severe disease was defined as a value of greater than 450.

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both
• Include criteria: All participants in Japan who received teduglutide will be enrolled in this post marketing surveillance.
• Exclude criteria: None

Related Information

• Primary Sponsor: Contact for Clinical Trial Information
• Secondary ID(s): NCT05023382