Trials / Completed
CompletedNCT03268811
A Study in Japanese Children With Short Bowel Syndrome Who Completed SHP633-302
A Prospective, Open-label, Long-term Safety and Efficacy Study of Teduglutide in Japanese Pediatric Subjects With Short Bowel Syndrome Who Completed SHP633-302
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 9 (actual)
- Sponsor
- Shire · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
The purpose of this clinical study is to evaluate the long-term safety and tolerability of teduglutide treatment in Japanese pediatric participants with short bowel syndrome (SBS) who completed Study SHP633-302 (NCT02980666).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Teduglutide | Teduglutide 0.05 mg/kg SC injection will be administered once daily into 1 of the 4 quadrants of the abdomen or either thigh or arm. |
Timeline
- Start date
- 2017-08-23
- Primary completion
- 2021-11-02
- Completion
- 2021-11-02
- First posted
- 2017-08-31
- Last updated
- 2022-05-24
- Results posted
- 2022-05-24
Locations
6 sites across 1 country: Japan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03268811. Inclusion in this directory is not an endorsement.