Clinical trials: SBS
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
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
Prematurity, Intestine Perforation
Early Supplementation of Enteral Microlipid With and Without Fish Oil in Premature Infants With Enterostomies
Necrotizing enterocolitis (NEC) and spontaneous intestinal perforation (SIP) are common devastating gastrointestinal diseases in premature infants.
- Conditions
- Prematurity, Intestine Perforation, Necrotizing Enterocolitis (NEC), Short Bowel Syndrome (SBS)
- Trial name
- EMLFO-2 (NCT01674478)
- Testing
- Microlipid with fish oil, Microlipid
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Wake Forest University
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
Safety and Efficacy Study of Teduglutide in Subjects With Short Bowel Syndrome Who Completed Protocol CL0600-004 (NCT00081458)
The purpose of this clinical study is to evaluate the long-term safety and efficacy of daily administration of teduglutide.
- Trial name
- NCT00172185
- Testing
- teduglutide 0.05 mg/kg/d, teduglutide 0.10 mg/kg/d
- Where
- 21 sites in United States, Belgium and 6 more
- Volunteers
- 65 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
Cancer
A Study to Evaluate Safety, Tolerability and Preliminary Efficacy of FP-1305 in Cancer Patients (MATINS)
This is a first in human study to identify whether FP-1305 is suitable to use in humans. The previous pre-clinical studies have demonstrated that FP-1305 binds to a receptor known as CLEVER-1.
- Trial name
- NCT03733990
- Testing
- FP-1305 (bexmarilimab)
- Where
- 11 sites in United States, Finland and 4 more
- Volunteers
- 216 people
- Sponsor
- Faron Pharmaceuticals Ltd
Short Bowel Syndrome
Study of Teduglutide Effectiveness in Parenteral Nutrition (PN)-Dependent Short Bowel Syndrome (SBS) Subjects
Teduglutide is an investigative medicine being evaluated as a possible treatment for people with parenteral nutrition (PN) dependent Short Bowel Syndrome (SBS). Teduglutide is similar to a protein the body makes.
- Trial name
- STEPS (NCT00798967)
- Testing
- teduglutide
- Where
- 35 sites in United States, Canada and 8 more
- Volunteers
- 86 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
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
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.
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
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
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
Evaluate the Efficacy and Safety Growth Hormone, Glutamine and Diet in Patients With Short Bowel Syndrome (SBS)
Treatment for 3.5-8 weeks with GH (0.05 mg/kg/day) +GLN+Diet, followed by continued compliance to the individualized oral diet and enteral GLN, will result in reduced volume of TPN infusion/week and/or reduced frequency of TPN…
- Trial name
- NCT00742157
- Testing
- Growth Hormone
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- University of Nebraska
Blood Platelet Disorders
Efficacy of Eltrombopag to Improve Thrombocytopenia of MYH9-related Disease
The term MYH9-related disease (MYH9RD) includes four genetic disorders: May-Hegglin anomaly, Sebastian syndrome, Fechtner syndrome, and Epstein syndrome.
- Trial name
- NCT01133860
- Testing
- eltrombopag
- Where
- 3 sites in Italy
- Volunteers
- 12 people
- Sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
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