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NCT00930644 · ClinicalTrials.gov registry record · Phase 3
Open-Label Study of Teduglutide for Subjects With PN-Dependent Short Bowel Syndrome (SBS)
A Phase 3 study of Short Bowel Syndrome, sponsored by Shire.
- Completed
- Registry status
- Phase 3
- Development phase
- 88
- Enrollment target
- 20
- Study locations
NCT00930644: Completed Phase 3 study of Short Bowel Syndrome, sponsored by Shire.
NCT00930644 is a Phase 3 study of Short Bowel Syndrome that has completed, run by Shire. The registered enrollment target is 88 participants, below the 180-participant average among 17 other Short Bowel Syndrome trials with a reported enrollment target (51% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00930644, a Phase 3 study of Short Bowel Syndrome, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 88 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
The mean change from baseline in weekly PN.IV volume in percent change is shown by visit.
Conditions Studied
Interventions
- DRUG teduglutide
Study Locations (20)
Other
- Rigshospitalet - Copenhagen
- Hôpital Beaujon - Clichy
- Hopital de l'Archet 2 - Nice
- Azienda Universitaria Policlinico Federico II - Naples
- Wojewodzki Szpital Specjalistyczny im. M. Pirogowa, Pracownia Leczenia Zywieniowego - Lodz
- Samodzielny Publiczny Szpital Kliniczny nr 4, Klinika Chirurgii Ogolnej i Transplantacyjnej - Lublin
- Pracownia Żywienia Klinicznego - Olsztyn
- Samodzielny Publiczny Szpital Kliniczny-Im.prof W.Orłowskiego CMKP - Warsaw
- Hospital Universitario de Bellvitge - Barcelona
Pennsylvania
- University of Pennslyvania - Philadelphia
- University Of Pittsburgh Medical Center - Pittsburgh
Ontario
- St. Michael's Hospital - Toronto
- University Health Network - Toronto General Hospital - Toronto
California
- Scripps Clinic & Research Foundation - La Jolla
New York
- Mount Sinai Medical Center - New York
Ohio
- Cleveland Clinic Foundation - Cleveland
Tennessee
- Vanderbilt University Medical Center - Nashville
Alberta
- Royal Alexandra Hospital - Edmonton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 88 participants |
| Start Date | 2009-09-21 |
| Est. Completion | 2013-01-24 |
| Phase | Phase 3 |
What the finished NCT00930644 record still lists
NCT00930644 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 88 participants, a relatively small participant target, below the 180-participant average among 17 other Short Bowel Syndrome trials with a reported enrollment target (51% lower).
The record links to 1 condition, with Short Bowel Syndrome appearing as the primary indexed condition, and to 1 intervention - of which teduglutide is the first listed.
NCT00930644 names 20 study sites across 10 states, led by Other, Pennsylvania, Ontario.
Frequently Asked Questions
What is clinical trial NCT00930644 about?
NCT00930644 is a clinical study titled "Open-Label Study of Teduglutide for Subjects With PN-Dependent Short Bowel Syndrome (SBS)". 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.
What is the current status of trial NCT00930644?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 88 participants. The study started on 2009-09-21. Estimated completion is 2013-01-24.
What conditions does trial NCT00930644 study?
This clinical trial studies the following conditions: Short Bowel Syndrome.
What interventions are being tested in trial NCT00930644?
The interventions under investigation include: teduglutide (DRUG).
Who is sponsoring clinical trial NCT00930644?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00930644 being conducted?
This trial has 20 study locations across California, New York, Ohio, Pennsylvania, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Short Bowel Syndrome
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00930644's enrollment target sits among peer trials
88 9th of 17 higher than 9 of 17 other Short Bowel Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Short Bowel Syndrome trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Efficacy And Safety Evaluation of Glepaglutide in Treatment of SBS
RECRUITING · Phase 3
-
Evaluation of Long Term Safety and Efficacy of Glepaglutide in Treatment of SBS
ACTIVE NOT RECRUITING · Phase 3
-
Evaluation of Long Term Safety and Efficacy of Glepaglutide in Treatment of SBS - Extension Trial
ACTIVE NOT RECRUITING · Phase 3
-
Open-label Extension Trial to Evaluate the Long-term Safety of Apraglutide in Short Bowel Syndrome.
ACTIVE NOT RECRUITING · Phase 3
-
Trial to Evaluate Efficacy and Safety of Apraglutide in SBS-IF
COMPLETED · Phase 3
-
Safety and Efficacy Study of Teduglutide in Subjects With Short Bowel Syndrome
COMPLETED · Phase 3
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