Clinical trials: Short Gut
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
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 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
Colorectal Cancer
A Study of Xeloda (Capecitabine) in Combination With Avastin + Short Course Chemotherapy in Patients With Metastatic Colorectal Cancer
This 2-arm study was designed to evaluate the efficacy and safety of 2 treatment regimens of Xeloda and Avastin, with either irinotecan or oxaliplatin administered for the first 12 cycles, as first line treatment in patients with…
- Trial name
- NCT00642603
- Testing
- capecitabine [Xeloda], bevacizumab [Avastin], oxaliplatin
- Where
- 76 sites in United States
- Volunteers
- 41 people
- Sponsor
- Hoffmann-La Roche
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
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
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
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
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 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
Study of Teduglutide in Japanese Participants With Short Bowel Syndrome
The objectives of this clinical study are to evaluate the safety, efficacy, and pharmacokinetics (PK) of teduglutide in Japanese participants with short bowel syndrome (SBS) who are dependent on parenteral nutrition/intravenous…
- Trial name
- NCT03663582
- Testing
- Teduglutide, Syringe, Needle
- Where
- 5 sites in Japan
- Volunteers
- 7 people
- Sponsor
- Shire
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
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
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
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
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
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
Safety, Efficacy and Pharmacokinetic Study of Teduglutide in Infants 4 to 12 Months of Age With Short Bowel Syndrome
The purpose of the study is to evaluate the safety, efficacy/pharmacodynamics (PD) and pharmacokinetics (PK) of teduglutide treatment in infants with short bowel syndrome (SBS) dependent on parenteral (PN) support.
- Trial name
- NCT03571516
- Testing
- Teduglutide, Standard Medical Therapy, Syringe
- Where
- 8 sites in Finland, France and 2 more
- Volunteers
- 10 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
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