Observing the effects of teduglutide in Japanese patients with short bowel syndrome
Special Drug Use Investigation of Revestive Subcutaneous Injection 3.8 mg (All-case Surveillance)
This study is looking at how well teduglutide works and what side effects it has for Japanese patients with short bowel syndrome over three years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Sex | All |
| Sponsor | Takeda Industry-sponsored |
| Locations | 2 sites (Tokyo and 1 other locations) |
| Trial ID | NCT05023382 on ClinicalTrials.gov |
What this trial studies
This study aims to monitor the side effects and symptom control of teduglutide (Revestive) in individuals diagnosed with short bowel syndrome in Japan. Participants will receive subcutaneous injections of teduglutide as per their clinic's standard practice, and the study will track their experiences over a period of 36 months. The study is observational, meaning the sponsor will not influence treatment but will provide guidelines for data collection. The focus is on understanding the real-world effects of teduglutide in this specific patient population.
Who should consider this trial
Good fit: Ideal candidates for this study are Japanese individuals diagnosed with short bowel syndrome who are receiving teduglutide treatment.
Not a fit: Patients who are not receiving teduglutide or those with conditions other than short bowel syndrome may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the safety and efficacy of teduglutide for managing short bowel syndrome in Japanese patients.
How similar studies have performed: While this study is observational, similar studies on teduglutide have shown promising results in other populations, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All participants in Japan who received teduglutide will be enrolled in this post marketing surveillance. Exclusion Criteria: * None
Where this trial is running
Tokyo and 1 other locations
- Takeda Selected Site — Tokyo, Japan (Not_yet_recruiting)
- Takeda selected site — Tokyo, Japan (Recruiting)
Study contacts
- Study coordinator: Takeda Contact
- Email: medinfoUS@takeda.com
- Phone: +1-877-825-3327
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.