Clinical trials: Short Bowel
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
Long-term Study of Teduglutide in Pediatric Subjects With Short Bowel Syndrome Who Completed the TED-C13-003 Study
The purpose of this study is to evaluate the safety and efficacy of teduglutide treatment of children with short bowel syndrome (SBS) who completed the TED-C13-003 study over a long-term period.
- Trial name
- NCT02949362
- Testing
- Teduglutide, SOC
- Where
- 11 sites in United States, United Kingdom
- Volunteers
- 29 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, Parenteral Nutrition Associated Liver Disease
Study of NST-6179 in Healthy Subjects
A double-blind, randomized, placebo controlled, single and multiple oral dose study to assess safety and tolerability of single and multiple doses of NST-6179 in healthy male and female subjects.
- Trial name
- NCT05181085
- Testing
- NST 6179
- Where
- United Kingdom
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- NorthSea Therapeutics B.V.
Short Bowel Syndrome
A Study of Teduglutide in Japanese Children With Short Bowel Syndrome Aged 4 Months or Older
The main aims of the study are to check for side effects from teduglutide. Participants will receive a daily injection of teduglutide just under the skin (subcutaneous) for 24 weeks. Then they are followed up for another 4 weeks.
- Trial name
- NCT05027308
- Testing
- Teduglutide
- Where
- 6 sites in Japan
- Volunteers
- 3 people
- Sponsor
- Takeda
Essential Fatty Acid Deficiency (EFAD)
Pediatric Study to Evaluate Risk of Developing Essential Fatty Acid Deficiency When Receiving Clinolipid or Standard-of-Care Lipid Emulsion (Part A)
This will be a descriptive study designed to evaluate the propensity for hospitalized pediatric patients treated adequately with Clinolipid or standard of care (Intralipid) from 7 up to 90 days to develop Essential Fatty Acid…
- Trial name
- NCT04555044
- Testing
- Clinolipid, Intralipid
- Where
- 9 sites in United States
- Volunteers
- 101 people
- Sponsor
- Baxter Healthcare Corporation
Short Bowel Syndrome
An Extension Study of Teduglutide in Japanese Participants With Short Bowel Syndrome Who Completed 24 Weeks of Treatment in SHP633-306 or TED-C14-004
The purpose of this clinical study is to evaluate the long-term safety and efficacy of teduglutide in Japanese participants with PN/IV (parenteral nutrition/intravenous)-dependent SBS (short bowel syndrome) who completed…
- Trial name
- NCT03596164
- Testing
- Teduglutide, Syringe, Needle
- Where
- 5 sites in Japan
- Volunteers
- 11 people
- Sponsor
- Takeda
Short Bowel Syndrome
Efficacy, Safety and Tolerability of Enteric-Coated Cholestyramine Capsules for Adult Short Bowel Syndrome
A new Enteric-Coated Cholestyramine (ECC) capsule has been developed to manage diarrhea associated with Short Bowel Syndrome (SBS) in adults.
- Trial name
- NCT04046328
- Testing
- Enteric-Coated Cholestyramine (ECC) Capsule
- Where
- 3 sites in Poland
- Volunteers
- 13 people
- Sponsor
- Pharmascience Inc.
Short Bowel Syndrome
A Study in Japanese Children With Short Bowel Syndrome Who Completed SHP633-302
The purpose of this clinical study is to evaluate the long-term safety and tolerability of teduglutide treatment in Japanese pediatric participants with short bowel syndrome (SBS) who completed Study SHP633-302 (NCT02980666).
- Trial name
- NCT03268811
- Testing
- Teduglutide
- Where
- 6 sites in Japan
- Volunteers
- 9 people
- Sponsor
- Shire
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
Safety and Efficacy Study in Infant With SBS
The objective of this clinical study is to evaluate the efficacy and safety of NTRA-9620 compared with placebo in pediatric subjects (aged 28 weeks postmenstrual age to 52 weeks old) with SBS following surgical resection
- Trial name
- GIFT (NCT02865122)
- Testing
- NTRA-9620
- Where
- 8 sites in United States
- Volunteers
- 2 people
- Sponsor
- Elgan Pharma Ltd.
Essential Fatty Acid Deficiency (EFAD)
Pediatric Study to Evaluate Risk of Developing Essential Fatty Acid Deficiency When Receiving Clinolipid or Standard-of-Care Lipid Emulsion
This will be a descriptive study designed to evaluate the propensity for hospitalized pediatric patients treated adequately with Clinolipid or standard of care for up to 90 days to develop Essential Fatty Acid Deficiency (EFAD).
- Trial name
- NCT02476994
- Testing
- Clinolipid, Intralipid
- Where
- 4 sites in United States
- Volunteers
- 1 people
- Sponsor
- Baxter Healthcare Corporation
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
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
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
Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Teduglutide in Japanese Subjects With PN-dependent Short Bowel Syndrome (SBS)
The purpose of this study is to evaluate the safety and efficacy of an investigational treatment (teduglutide) in Japanese patients with PN-dependent SBS.
- Trial name
- NCT02340819
- Testing
- Teduglutide
- Where
- 5 sites in Japan
- Volunteers
- 11 people
- Sponsor
- Shire
Short Bowel Syndrome
Short Bowel Syndrome Research Study for Children Up To 17 Years of Age on Parenteral Nutrition
Teduglutide is approved for treatment of adults with short bowel syndrome (SBS). The purpose of this study is to evaluate the safety and efficacy of teduglutide in children up to the age of 17 with SBS who are dependent on…
- Trial name
- NCT02682381
- Testing
- Teduglutide 0.05mg/kg, Teduglutide 0.025 mg/kg, Standard of Care
- Where
- 27 sites in United States, Belgium and 5 more
- Volunteers
- 59 people
- Sponsor
- Shire