Clinical trials: Short Bowel Syndrome (SBS)
Short Bowel Syndrome
Trial to Evaluate Efficacy and Safety of Apraglutide in SBS-IF
The primary objective of the trial is the confirmation of the efficacy of apraglutide to evaluate the efficacy of weekly subcutaneous apraglutide in reducing parenteral support dependency.
- Trial name
- STARS (NCT04627025)
- Testing
- apraglutide
- Where
- 68 sites in United States, Argentina and 16 more
- Volunteers
- 164 people
- Sponsor
- VectivBio AG
Short Bowel Syndrome (SBS)
Efficacy and Safety Evaluation of Glepaglutide in Treatment of Short Bowel Syndrome
The purpose of this study is to understand the safety and efficacy of twice weekly glepaglutide 10 mg in adult patients with short bowel syndrome (SBS), who were previously enrolled in the EASE SBS 2 or EASE SBS 3 trials.
- Trial name
- EASE SBS 6 (NCT07228403)
- Testing
- Glepaglutide 10 mg
- Where
- 16 sites in United States, Belgium and 5 more
- Volunteers
- 28 people
- Sponsor
- Zealand Pharma
Short Bowel Syndrome
A Pharmacokinetic, Safety, and Pharmacodynamic Study of Teduglutide in Pediatric Subjects With Short Bowel Syndrome
This will be an open label, 4-cohort study. Non-randomized subjects will receive teduglutide in each of the 3 active cohorts. An attempt will be made to enroll additional subjects into an observational cohort who will receive…
- Trial name
- NCT01952080
- Testing
- teduglutide
- Where
- 19 sites in United States, United Kingdom
- Volunteers
- 42 people
- Sponsor
- Shire
Short Bowel Syndrome (SBS), SBS Associated With Intestinal Failure (SBS-IF)
A Study to Investigate the Efficacy and Safety of Apraglutide Compared With Placebo in Adult Participants With Short Bowel Syndrome Associated With Intestinal Failure (SBS-IF)
This Phase 3 placebo-controlled study is planned to further investigate the efficacy, safety, and tolerability of apraglutide in the overall SBS-IF (short bowel syndrome associated with intestinal failure) population during 24…
- Trial name
- STARS-2 (NCT07742735)
- Testing
- Apraglutide
- Where
- 94 sites in United States, Argentina and 20 more
- Volunteers
- 124 people
- Sponsor
- VectivBio AG
Short Bowel Syndrome
Safety and Efficacy Study of Teduglutide in Subjects With Short Bowel Syndrome
The purpose of this study is to evaluate the efficacy, safety, tolerability, and pharmacokinetics (PK) of teduglutide compared with placebo in subjects with parenteral nutrition (PN)-dependent short bowel syndrome (SBS).
- Trial name
- NCT00081458
- Testing
- Teduglutide 0.05 mg/kg/d, Teduglutide 0.1 mg/kg/d
- Where
- 32 sites in United States, Belgium and 7 more
- Volunteers
- 84 people
- Sponsor
- Shire
Short Bowel Syndrome
The Long-term Effect on Intestinal Absorption and Safety of Treatment With Glepaglutide in Patients With Short Bowel Syndrome
The purpose of this trial is to investigate the long-term effect of glepaglutide on the intestinal absorption, nutritional status of participants with Short Bowel Syndrome (SBS).
- Trial name
- EASE SBS 4 (NCT04991311)
- Testing
- Glepaglutide
- Where
- Denmark
- Volunteers
- 12 people
- Sponsor
- Zealand Pharma
Short Bowel Syndrome
Evaluation of Long Term Safety and Efficacy of Glepaglutide in Treatment of SBS - Extension Trial
This trial is an extension trial to EASE SBS 2. The study looks at whether glepaglutide is a safe treatment for participants with Short Bowel Syndrome (SBS), as well as how well effectiveness is maintained during long term…
- Trial name
- EASE SBS 3 (NCT04881825)
- Testing
- Glepaglutide
- Where
- 19 sites in United States, Belgium and 6 more
- Volunteers
- 84 people
- Sponsor
- Zealand Pharma
Short Bowel Syndrome
Phase 2 Study to Assess the Safety, PK, and PD of Sonefpeglutide (HM15912) in SBS-IF Subjects
This is a randomized, double-blind, placebo-controlled, proof-of-concept (PoC), Phase 2 study to assess the safety, PK, and PD of SC administration of HM15912(sonefpeglutide) in adult subjects with SBS-associated intestinal…
- Trial name
- NCT04775706
- Testing
- HM15912 Active
- Where
- 15 sites in United States, Belgium and 6 more
- Volunteers
- 18 people
- Sponsor
- Hanmi Pharmaceutical Company Limited
Short Bowel Syndrome
Study in Japanese Pediatric Subjects With Short Bowel Syndrome (SBS) Who Are Dependent on Parenteral Support
The purpose of this study is to determine if an investigational treatment (teduglutide) is safe and effective in Japanese children (age 4 months through 15 years of age) with SBS who are dependent on parenteral support.
- Trial name
- NCT02980666
- Testing
- Teduglutide
- Where
- 5 sites in Japan
- Volunteers
- 10 people
- Sponsor
- Shire
Short Bowel Syndrome
Efficacy And Safety Evaluation of Glepaglutide in Treatment of Short Bowel Syndrome (SBS)
The primary objective of the trial is to confirm the efficacy of glepaglutide in reducing parenteral support volume in patients with short bowel syndrome. Glepaglutide is the International Nonproprietary Name and USAN for ZP1848.
- Trial name
- EASE SBS 1 (NCT03690206)
- Testing
- glepaglutide
- Where
- 29 sites in United States, Belgium and 7 more
- Volunteers
- 106 people
- Sponsor
- Zealand Pharma
Short Bowel Syndrome
Metabolic Balance Study of Apraglutide in Patients With Short Bowel Syndrome, Intestinal Failure (SBS-IF) and Colon-in-Continuity (CIC)
The primary objective of the trial is to evaluate the safety of apraglutide in adult subjects with SBS-IF and CIC.
- Trial name
- STARSnutrition (NCT04964986)
- Testing
- Apraglutide
- Where
- 2 sites in Belgium, France
- Volunteers
- 10 people
- Sponsor
- VectivBio AG
Short Bowel Syndrome
Long-term Safety and Efficacy Study of Teduglutide in Pediatric Participants With Short Bowel Syndrome (SBS)
This study will follow participants who completed the TED-C14-006 study. The purpose of this study is to evaluate the long-term safety and efficacy of teduglutide in pediatric participants with Short Bowel Syndrome (SBS).
- Trial name
- NCT02954458
- Testing
- TED, SOC, Syringe
- Where
- 22 sites in United States, Belgium and 4 more
- Volunteers
- 61 people
- Sponsor
- Shire
Short Bowel Syndrome (SBS)
Retrospective Study on Participants With Short Bowel Syndrome and Chronic Intestinal Failure That Underwent Transplantation in Brazil
The main aim of this study is to capture management and treatment outcome data in participants with short bowel syndrome and chronic intestinal failure (SBS-IF) that underwent intestinal transplantation in Brazil.
- Trial name
- NCT05113082
- Where
- Brazil
- Volunteers
- 7 people
- Sponsor
- Takeda
Short Bowel Syndrome
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.
- Trial name
- NCT00930644
- Testing
- teduglutide
- Where
- 23 sites in United States, Canada and 7 more
- Volunteers
- 88 people
- Sponsor
- Shire
Short Bowel Syndrome
A One-Year, Open-Label Study With Teduglutide for Subjects Who Completed Study CL0600-021
This study is a 1-year open label extension study to collect long term efficacy and safety data from patients who have completed approximately 2 years of dosing in Study CL0600-021.
- Trial name
- STEPS3 (NCT01560403)
- Testing
- Teduglutide
- Where
- 5 sites in United States
- Volunteers
- 14 people
- Sponsor
- Shire
Short Bowel Syndrome (SBS)
A Survey to Assess Participants' and Physicians' Knowledge When Using GATTEX (Knowledge Assessment Survey)
The study is about learning and documenting how well participants and physicians understand how to use GATTEX and about potential risks by using a survey (called Knowledge Assessment Survey).
- Trial name
- NCT05561647
- Testing
- No Intervention
- Where
- United States
- Volunteers
- 600 people
- Sponsor
- Takeda
Short Bowel Syndrome, SBS
A Clinical Study of FT1 in Patients With Short Bowel Syndrome
The goal of this clinical trial is to learn if FT1 is safe and works to treat short bowel syndrome (SBS) in adults. It will also learn about the PK/PD profile of FT1.
- Trial name
- NCT07704047
- Testing
- FT1
- Where
- China
- Volunteers
- 8 people
- Sponsor
- Chongqing Peg-Bio Biopharm Co., Ltd.
Short Bowel Syndrome, Short Gut Syndrome
A Phase III Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Investigational Product MP-101 in Subjects With Short Bowel Syndrome Who Have Had an Inadequate Response to Anti-Diarrheals
MP-101 will be evaluated in this study to see if it is safe, tolerable, and can help people with Short Bowel Syndrome. This study will also find out if taking MP-101 can improve the symptoms of Short Bowel Syndrome and reduce the…
- Conditions
- Short Bowel Syndrome, Short Gut Syndrome, SBS, Short Bowel
- Trial name
- NCT02242656
- Testing
- Opium Tincture USP Deodorized
- Where
- 5 sites in United States
- Sponsor
- Marathon Pharmaceuticals, LLC
Short Bowel Syndrome (SBS)
A Study of Teduglutide in Chinese Children and Teenagers With Short Bowel Syndrome
Short Bowel Syndrome (SBS) is a rare condition that happens when a large part of the bowel (also called intestine) is missing or has been removed because of illness or surgery.
- Trial name
- NCT07319832
- Testing
- No Intervention
- Where
- 4 sites in China
- Volunteers
- 12 people
- Sponsor
- Takeda
Short Bowel Syndrome (SBS) in Adults
Phase IV Study of rhGH Injection in Adult Short Bowel Syndrome
This is a multicenter, open-label, single-arm clinical trial. A total of 100 participants with short bowel syndrome (SBS) receiving parenteral nutrition (PN) support are planned to be enrolled.
- Trial name
- NCT07691125
- Testing
- rhGH injection
- Where
- 2 sites in China
- Volunteers
- 100 people
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.