A Long-Term, Open-Label Study With Teduglutide for Subjects With Parenteral Nutrition Dependent Short Bowel Syndrome
Overview
- Phase
- Phase 3
- Intervention
- teduglutide
- Conditions
- Short Bowel Syndrome
- Sponsor
- Shire
- Enrollment
- 88
- Locations
- 23
- Primary Endpoint
- Percent Change in PN/IV Volume by Visit
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
This study is a 2-year open label extension study to collect long term efficacy and safety data from patients who have completed the 24-weeks of study drug dosing in CL0600-020.
Detailed Description
Some people with SBS need to infuse parenteral nutrition (PN) in order to live. Although PN can save lives, it can lead to some serious side effects such as infection or liver damage. The risk for those effects increases the longer people are on PN. Teduglutide is an investigative medicine being evaluated as a possible treatment for people with PN-dependent SBS. Teduglutide is similar to a protein the body makes. When people have SBS, their bodies do not make enough of the protein and they have trouble getting nutrients and fluids from the food they eat and drink. We want to see if teduglutide can help decrease the amount of PN needed because the body is doing a better job of taking up what it eats and drinks. We also want to find out how safe teduglutide is and record any side effects.
Investigators
Eligibility Criteria
Inclusion Criteria
- •must have completed 24 weeks of dosing of the CL0600-020 study
Exclusion Criteria
- Not provided
Arms & Interventions
teduglutide
0.05 mg/kg/day
Intervention: teduglutide
Outcomes
Primary Outcomes
Percent Change in PN/IV Volume by Visit
Time Frame: 24 months
The mean change from baseline in weekly PN.IV volume in percent change is shown by visit.
Absolute Change in PN/IV Volume by Visit
Time Frame: 24 months
The mean change from baseline in weekly PN.IV volume in Liters is shown by visit.
Secondary Outcomes
- Number of Subjects Achieving PN/IV Reduction(24 Months or Last Dosing Visit)