Clinical trials: Short Bowel Syndrome
Short Bowel Syndrome
Efficacy and Safety of PJ009 in Patients With Short Bowel Syndrome Requiring Parenteral Nutrition
The main aim of this clinical trial is to assess the efficacy and safety of PJ009 in patients aged ≥14 with short bowel syndrome (SBS) requiring parenteral nutrition.
- Trial name
- NCT06512584
- Testing
- PJ009
- Where
- 8 sites in China
- Volunteers
- 72 people
- Sponsor
- Chongqing Peg-Bio Biopharm Co., Ltd.
Enteric Hyperoxaluria
Efficacy and Safety of TRA16 Administered Orally in Patients With Enteric Hyperoxaluria (EH).
A Phase II, Multi-center, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of TRA16 Administered Orally in Patients with Enteric Hyperoxaluria (EH).
- Trial name
- NCT07871669
- Testing
- TRA16
- Volunteers
- 30 people
- Sponsor
- Wuhan Kangfude Urolithiasis Research Institute Co., Ltd.
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
Efficacy And Safety Evaluation of Glepaglutide in Treatment of SBS
The purpose of the present Phase 3 trial is to confirm the efficacy and safety of glepaglutide 10 mg twice weekly in a patient population with SBS-IF and generate additional long-term safety data.
- Trial name
- EASE SBS 5 (NCT07197944)
- Testing
- Glepaglutide
- Where
- 33 sites in United States, Austria and 12 more
- Volunteers
- 90 people
- Sponsor
- Zealand Pharma
Short Bowel Syndrome
Registry for Participants With Short Bowel Syndrome
This is a global prospective, observational, multi-center registry to evaluate the long-term safety profile for participants with short bowel syndrome (SBS) who are treated with teduglutide in a routine clinical setting.
- Trial name
- NCT01990040
- Where
- United States
- Volunteers
- 1,806 people
- Sponsor
- Shire
Short Bowel Syndrome
Evaluation of Long Term Safety and Efficacy of Glepaglutide in Treatment of SBS
The primary objective of the trial is to evaluate the long-term safety of glepaglutide treatment in patients with short bowel syndrome (SBS). Glepaglutide is the International Nonproprietary Name and USAN for ZP1848.
- Trial name
- EASE SBS 2 (NCT03905707)
- Testing
- glepaglutide
- Where
- 27 sites in United States, Belgium and 7 more
- Volunteers
- 150 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
A Study of Teduglutide in Chinese Adults With Short Bowel Syndrome
The main aim of the study is to assess how well teduglutide works over 24 weeks in Chinese adult participants with short bowel syndrome (SBS) who need parenteral support and to see how much it can reduce the amount of parenteral…
- Trial name
- NCT06973304
- Testing
- Teduglutide
- Where
- 4 sites in China
- Volunteers
- 13 people
- Sponsor
- Takeda
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
A Study of Teduglutide in Japanese People With Short Bowel Syndrome
The main aims of this study are to check for side effects from treatment with teduglutide (Revestive) and how well teduglutide controls symptoms of short bowel syndrome.
- Trial name
- NCT05023382
- Testing
- Teduglutide
- Where
- Japan
- Volunteers
- 250 people
- Sponsor
- Takeda
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 (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, 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 (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.
Short Bowel Syndrome, Malabsorption Syndromes
Safety and Efficacy of Crofelemer in Adult Patients With Short Bowel Syndrome and Intestinal Failure (SBS-IF) Without Colon-in-continuity (CIC)
A 24-week, randomized, placebo-controlled, double-blind study to evaluate the efficacy, safety and tolerability of crofelemer in patients with Short Bowel Syndrome and Intestinal Failure (SBS-IF) without colon-in-continuity (CIC)…
- Conditions
- Short Bowel Syndrome, Malabsorption Syndromes, Short Gut Syndrome, Post-Op Complication
- Trial name
- CRO-SBS-IF (NCT06904872)
- Testing
- Crofelemer Powder for Oral Solution
- Where
- 8 sites in Germany, Italy
- Volunteers
- 18 people
- Sponsor
- Napo Therapeutics, S.p.A.
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
Gastrointestinal Disease, Inflammatory Bowel Disease (IBD)
Elemental 028 Extra Case Studies
Elemental 028 Extra is a nutritionally complete ACBS approved amino acid-based (elemental) feed designed to provide adequate daily amounts of both macronutrients and micronutrients when used as a sole source of nutrition and to…
- Conditions
- Gastrointestinal Disease, Inflammatory Bowel Disease (IBD), Short Bowel, Malabsorption
- Trial name
- E028E (NCT06877923)
- Testing
- Elemental 028 Extra
- Where
- United Kingdom
- Volunteers
- 30 people
- Sponsor
- Nutricia UK Ltd
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
Open-label Extension Trial to Evaluate the Long-term Safety of Apraglutide in Short Bowel Syndrome.
The primary objective of the trial is to assess long-term safety and tolerability of apraglutide in subjects with SBS-IF.
- Trial name
- STARS extend (NCT05018286)
- Testing
- Apraglutide
- Where
- 66 sites in United States, Argentina and 16 more
- Volunteers
- 158 people
- Sponsor
- VectivBio AG
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