13 completed, 1 active not recruiting, 1 recruiting, 1 withdrawn. 7 Phase 3, 4 Phase 2, 2 Phase 1, 1 Not applicable, 1 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 7 | Completed 5, Active not recruiting 1, Withdrawn 1 |
| Phase 2 | 4 | Completed 4 |
| Phase 1 | 2 | Completed 2 |
| Not applicable | 1 | Recruiting 1 |
| Phase 4 | 1 | Completed 1 |
Follow ALX-0600: new trials by email Literature Review of ALX-0600 trials Research Report on ALX-0600
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Study of Teduglutide in Chinese Adults With Short Bowel Syndrome Teduglutide - Short Bowel Syndrome | Phase 3 | Active not recruiting | Takeda | 13 | 2025-06-26 | 2026-09-08 |
| TED_ORG: Study on Short Bowel Syndrome Teduglutide (ALX-0600), No Treatment Added - Short Bowel Syndrome (SBS) | Not applicable | Recruiting | Meyer Children's Hospital IRCCS | 50 | 2024-10-30 | 2026-02-10 |
| Pilot Study to Investigate the Effect of Teduglutide on Temporary Ileostomy Function and Complications Teduglutide, Placebo - Ileostomy - Stoma | Phase 3 | Withdrawn | Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) | 2022-06-02 | 2023-02-23 | |
| Pediatric Teduglutide Registry Teduglutide - Short Bowel Syndrome | Completed | Boston Children's Hospital | 142 | 2021-05-18 | 2023-12-11 | |
| Teduglutide for Enterocutaneous Fistula (ECF) Teduglutide, Standard of Care - Postoperative Fistula | Phase 2 | Completed | Daniel Dante Yeh | 6 | 2019-01-31 | 2021-10-06 |
| A Study of the Gut Barrier and Blood Vessel Inflammation in Individuals With and Without HIV Teduglutide, Placebo - HIV | Phase 2 | Completed | Massachusetts General Hospital | 32 | 2015-12-01 | 2023-06-12 |
| Short Bowel Syndrome and Teduglutide Versus Placebo Teduglutide, Placebo - Short Bowel Syndrome | Phase 4 | Completed | Mayo Clinic | 8 | 2014-01-01 | 2016-02-22 |
| A One-Year, Open-Label Study With Teduglutide for Subjects Who Completed Study CL0600-021 Teduglutide - Short Bowel Syndrome | Phase 3 | Completed | Shire | 14 | 2012-05-21 | 2021-06-10 |
| Open-Label Study of Teduglutide for Subjects With PN-Dependent Short Bowel Syndrome (SBS) teduglutide - Short Bowel Syndrome | Phase 3 | Completed | Shire | 88 | 2009-09-21 | 2021-06-11 |
| Study of Teduglutide Effectiveness in Parenteral Nutrition (PN)-Dependent Short Bowel Syndrome (SBS) Subjects teduglutide, placebo - Short Bowel Syndrome | Phase 3 | Completed | Shire | 86 | 2008-11-25 | 2021-06-03 |
| Pharmacokinetics (PK) of 20 mg Teduglutide in Participants With Moderately Impaired Hepatic Function Compared to Healthy Participants Teduglutide - Hepatic Impairment | Phase 1 | Completed | Shire | 24 | 2007-07-26 | 2021-05-14 |
| A Double-Blind Multi-Dose Tolerability and Pharmacokinetic Study of Teduglutide teduglutide, tedguglutide - Pharmacokinetics and Safety of Elevated Doses | Phase 1 | Completed | Shire | 95 | 2006-09-06 | 2021-05-25 |
| Safety and Efficacy Study of Teduglutide in Subjects With Short Bowel Syndrome Who Completed Protocol CL0600-004 (NCT00081458) teduglutide 0.05 mg/kg/d, teduglutide 0.10 mg/kg/d - Short Bowel Syndrome | Phase 3 | Completed | Shire | 65 | 2005-01-10 | 2021-06-02 |
| Safety and Efficacy Study of Teduglutide in Subjects With Short Bowel Syndrome Placebo, Teduglutide 0.05 mg/kg/d, Teduglutide 0.1 mg/kg/d - Short Bowel Syndrome | Phase 3 | Completed | Shire | 84 | 2004-05-25 | 2021-06-09 |
| Safety and Efficacy of ALX-0600 in Subjects With Active Crohn's Disease Who Completed Protocol CL0600-008 Teduglutide (ALX-0600) - Crohn's Disease | Phase 2 | Completed | Shire | 67 | 2004-03-01 | 2021-05-14 |
| Safety and Efficacy of ALX-0600 in Subjects With Active Crohn's Disease ALX-0600, placebo, teduglutide 0.05 - Crohn's Disease | Phase 2 | Completed | Shire | 100 | 2003-11-12 | 2021-05-25 |
Short Bowel Syndrome (9) · Hyperphagia (5) · Crohn Disease (2) · Atherosclerosis (1) · Inflammation (1)
Shire (9) · Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) (1) · Boston Children's Hospital (1) · Daniel Dante Yeh (1) · Massachusetts General Hospital (1) · Mayo Clinic (1) · Meyer Children's Hospital IRCCS (1) · Takeda (1)
United States (14) · Canada (6) · Denmark (4) · France (4) · Poland (4) · United Kingdom (4) · Germany (3) · Italy (3) · Netherlands (3) · Belgium (2) · Spain (2) · China (1)
Daniel D Yeh, MD (1) · James McCormick, DO (1) · Janet Lo, MD, MMSc (1) · Lissette Jimenez (1) · Michael Camilleri, MD (1)
PMID 21317170, PMID 24134154, PMID 27507402, PMID 16099790, PMID 22982184, PMID 23274148, PMID 23333663, PMID 23587733, PMID 26223941, PMID 27855998, PMID 29174926, PMID 29761915, PMID 31495952, PMID 31784300, PMID 32341691, PMID 35871951, PMID 42754721
2004 (2), 2008 (1), 2009 (1), R01HL123351 (1), UL1TR000135 (1)