Trials / Completed
CompletedNCT02340819
Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Teduglutide in Japanese Subjects With PN-dependent Short Bowel Syndrome (SBS)
A 4-Stage, Open-label, Multicenter Study Including Long-term Extension to Evaluate the Safety, Efficacy and Pharmacokinetics of Teduglutide in Japanese Subjects With PN-dependent Short Bowel Syndrome
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 11 (actual)
- Sponsor
- Shire · Industry
- Sex
- All
- Age
- 16 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the safety and efficacy of an investigational treatment (teduglutide) in Japanese patients with PN-dependent SBS. This study will also look at how teduglutide moves through the body (pharmacokinetics).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Teduglutide | 0.05 mg/kg/day administered by subcutaneous injection over a 24-week period. |
Timeline
- Start date
- 2014-12-18
- Primary completion
- 2018-11-05
- Completion
- 2018-11-05
- First posted
- 2015-01-19
- Last updated
- 2021-06-09
- Results posted
- 2019-11-20
Locations
5 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT02340819. Inclusion in this directory is not an endorsement.