Special Drug Use Investigation of Revestive Subcutaneous Injection 3.8 mg (All-case Surveillance)

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Observational
SUMMARY

The main aims of this study are to check for side effects from treatment with teduglutide (Revestive) and how well teduglutide controls symptoms of short bowel syndrome. The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study. During the study, participants with short bowel syndrome will receive an injection of teduglutide just under the skin (subcutaneous) according to their clinic's standard practice. The study doctors will check for side effects from teduglutide for 36 months.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• All participants in Japan who received teduglutide will be enrolled in this post marketing surveillance.

Locations
Other Locations
Japan
Takeda selected site
RECRUITING
Tokyo
Takeda Selected Site
NOT_YET_RECRUITING
Tokyo
Contact Information
Primary
Takeda Contact
medinfoUS@takeda.com
+1-877-825-3327
Time Frame
Start Date: 2021-09-01
Estimated Completion Date: 2026-02-28
Participants
Target number of participants: 120
Treatments
Teduglutide 0.05 milligram per kilogram (mg/kg)
Participants will receive Teduglutide 0.05 milligram per kilogram (mg/kg) subcutaneous (SC) injection once daily.
Related Therapeutic Areas
Sponsors
Leads: Takeda

This content was sourced from clinicaltrials.gov