Ongoing Clinical Trials for Short-Bowel Syndrome
There are currently 7 clinical trials investigating new treatments for Short-Bowel Syndrome across multiple European countries. These studies are evaluating several investigational medications, including HM15912, Crofelemer, Glepaglutide, and Apraglutide, as well as examining how existing medications like Apixaban and Rivaroxaban work in patients who require long-term parenteral nutrition. The trials aim to improve nutrient absorption, reduce the need for intravenous feeding, and enhance quality of life for those affected by this condition.
Clinical trial locations
- Belgium
- Study on How Apixaban and Teduglutide Affect Patients with Short Bowel Syndrome on Long-Term Parenteral Nutrition
- Study of HM15912 for Adults with Short Bowel Syndrome-associated Intestinal Failure
- Long-term safety study of apraglutide (weekly injections) in patients with Short Bowel Syndrome
- Study on the Long-Term Safety and Effectiveness of Glepaglutide for Patients with Short Bowel Syndrome
- Study on the Long-Term Safety of Glepaglutide for Adults with Short Bowel Syndrome
- Czechia
- Denmark
- France
- Study of HM15912 for Adults with Short Bowel Syndrome-associated Intestinal Failure
- Long-term safety study of apraglutide (weekly injections) in patients with Short Bowel Syndrome
- Study on the Long-Term Safety and Effectiveness of Glepaglutide for Patients with Short Bowel Syndrome
- Study on the Long-Term Safety of Glepaglutide for Adults with Short Bowel Syndrome
- Germany
- Study of HM15912 for Adults with Short Bowel Syndrome-associated Intestinal Failure
- Study on Crofelemer for Adults with Short Bowel Syndrome and Intestinal Failure Without Colon in Continuity
- Long-term safety study of apraglutide (weekly injections) in patients with Short Bowel Syndrome
- Study on the Long-Term Safety and Effectiveness of Glepaglutide for Patients with Short Bowel Syndrome
- Study on the Long-Term Safety of Glepaglutide for Adults with Short Bowel Syndrome
- Hungary
- Italy
- Netherlands
- Norway
- Poland
- Study of HM15912 for Adults with Short Bowel Syndrome-associated Intestinal Failure
- Long-term safety study of apraglutide (weekly injections) in patients with Short Bowel Syndrome
- Study on the Long-Term Safety and Effectiveness of Glepaglutide for Patients with Short Bowel Syndrome
- Study on the Long-Term Safety of Glepaglutide for Adults with Short Bowel Syndrome
- Spain
- Sweden
Study of HM15912 for Adults with Short Bowel Syndrome-associated Intestinal Failure
This trial is evaluating HM15912, a human glucagon-like peptide-2 analogue linked to a human immunoglobulin FC fragment, designed to help improve intestinal function in patients whose small intestine is missing or not functioning properly.
Main inclusion criteria: Adults aged 18 years or older with intestinal failure resulting from the condition must weigh at least 30 kg and have a body mass index greater than 18. Participants need to have stable parenteral nutrition with less than 25% change in volume and energy over the past 4 weeks. The last intestinal surgery must have been at least 6 months ago with no planned surgeries during the study.
Main exclusion criteria: Patients with severe allergic reactions to the study medication ingredients, those participating in other trials within 30 days, individuals with drug or alcohol abuse in the past year, pregnant or breastfeeding women, and those with recent major surgery, uncontrolled high blood pressure or diabetes, active infections requiring antibiotics, or recent history of heart attack or stroke are excluded.
Trial focus: The study will assess the safety and tolerability of HM15912 over 24 weeks, monitoring how the body processes the medication and evaluating its effect on reducing the need for parenteral nutrition or intravenous fluids. Regular monitoring includes vital signs, electrocardiogram checks, and observation for injection site reactions.
Study on Crofelemer for Adults with Short Bowel Syndrome and Intestinal Failure Without Colon in Continuity
This double-blind trial investigates Crofelemer, a powder for oral solution that regulates fluid secretion in the intestines, specifically for patients who do not have a continuous colon.
Main inclusion criteria: Adults aged 18 or older who are receiving parenteral support at least three days per week and a minimum of 2 liters weekly must have at least 100 cm of remaining small bowel. At least 6 months must have passed since the last bowel surgery, and participants must have at least 4 continuous months of dependency on parenteral support. Patients must have chronic non-infectious diarrhea with at least one loose watery stool per day for more than 4 consecutive weeks.
Main exclusion criteria: Patients with a colon still connected, those under 18 years, and vulnerable populations requiring special protection cannot participate.
Trial focus: The 24-week study aims to assess the safety and preliminary effectiveness of Crofelemer in reducing the volume of parenteral support needed and improving stool consistency. Researchers will monitor liver and kidney function, glucose and lipid levels, and overall health throughout the treatment period.
Study on How Apixaban and Teduglutide Affect Patients with Short Bowel Syndrome on Long-Term Parenteral Nutrition
This study examines how the body processes Apixaban, a blood clot prevention medication, in patients with the condition compared to healthy volunteers, and also involves the medication Teduglutide.
Main inclusion criteria: Participants must have a small bowel length of less than 2 meters after the Treitz ligament and be on long-term parenteral nutrition or fluids for more than 3 months. Different groups include those who have not previously taken Apixaban or Teduglutide and those already taking Apixaban for at least 4 days. Healthy individuals without gastrointestinal surgeries can participate as controls.
Main exclusion criteria: Patients without the condition or those not requiring long-term parenteral nutrition are excluded.
Trial focus: The study aims to understand the absorption and processing of Apixaban in the body by comparing blood levels of the medication across different patient groups, which could help improve treatment options for those requiring long-term nutritional support.
Study on the Long-Term Safety and Effectiveness of Glepaglutide for Patients with Short Bowel Syndrome
This extension trial evaluates the long-term safety and effectiveness of Glepaglutide, a solution for subcutaneous injection designed to improve nutrient absorption.
Main inclusion criteria: Patients must have completed the full treatment phase of a previous lead-in trial and provide signed informed consent to participate in this extension study.
Main exclusion criteria: Patients not diagnosed with the condition, those younger than 1 year or older than 17 years, and vulnerable populations are excluded.
Trial focus: The study, continuing until 2026, monitors participants to assess how safe Glepaglutide is for long-term use and its effectiveness in reducing the volume of parenteral support needed. Regular assessments include vital signs, electrocardiograms, and various blood and urine tests to evaluate overall health and quality of life improvements.
Study on the Long-Term Safety of Glepaglutide for Adults with Short Bowel Syndrome
This trial focuses on evaluating the long-term safety of Glepaglutide treatment in adults over approximately two years.
Main inclusion criteria: Adult patients who have signed informed consent and completed the full treatment period of the previous EASE SBS 2 extension trial are eligible for this study.
Main exclusion criteria: Patients with severe allergic reactions to the study medication, those currently in another trial, individuals with certain interfering medical conditions like severe heart disease, pregnant or breastfeeding women, those with drug or alcohol abuse history, recent major surgery, uncontrolled high blood pressure, or severe liver or kidney disease are excluded.
Trial focus: Over 104 weeks, the study will monitor the safety and tolerability of Glepaglutide, tracking any adverse events and changes in health. Researchers will evaluate the medication’s effect on reducing parenteral support needs, with regular assessments of vital signs, heart function, and blood and urine tests.
Study on the Effects of Rivaroxaban in Patients with Short Bowel Syndrome on Long-Term Parenteral Nutrition
This observational study examines the effects of Rivaroxaban, marketed as Xarelto, which prevents blood clots, in patients requiring long-term intravenous feeding.
Main inclusion criteria: Adults aged 18 or older with a diagnosis of intestinal malabsorption from a specialist, currently using total parenteral nutrition, and needing anticoagulant therapy before starting such nutrition are eligible. Reasons for anticoagulation might include preventing strokes in people with irregular heartbeat or preventing blood clots in veins.
Main exclusion criteria: Patients without the condition, those not receiving long-term parenteral nutrition or not taking Rivaroxaban, and children younger than 3 years are excluded.
Trial focus: Over at least one year, the study will evaluate clinical and laboratory outcomes, monitoring blood clot or bleeding events and measuring medication levels in the blood. Quality of life assessments using standard questionnaires will help understand how individual medication absorption varies and its relationship to clinical outcomes.
Long-term safety study of apraglutide (weekly injections) in patients with Short Bowel Syndrome
This extensive study evaluates Apraglutide, a novel peptide belonging to the GLP-2 receptor agonist class, administered through weekly subcutaneous injections over approximately 6 years.
Main inclusion criteria: Participants must have completed previous clinical trials of Apraglutide, finishing at least 70% of planned doses and the last two scheduled visits without meeting stopping criteria. Women who can become pregnant must use effective birth control during the trial and for 4 weeks after, while men with partners who can become pregnant must use birth control during the trial and for 2 weeks after.
Main exclusion criteria: Those under 18 years, pregnant or breastfeeding women, individuals with intestinal obstruction in the past 6 months, active inflammatory bowel disease, current cancer, severe liver or kidney disease, unstable heart conditions, uncontrolled diabetes, planned major surgery, participation in another trial within 30 days, recent drug or alcohol abuse, or known allergies to study medication components are excluded.
Trial focus: The study, continuing until January 2030, will monitor participants through regular check-ups at specific intervals, evaluating safety through blood and urine tests, vital signs, electrocardiograms, and body weight measurements. Researchers will assess changes in parenteral nutrition needs, sleep quality, overall health status, treatment satisfaction, and quality of life impacts.
Summary
The seven ongoing clinical trials for patients with Short-Bowel Syndrome demonstrate a strong focus on developing and evaluating long-term treatment options that can reduce dependence on parenteral nutrition. Most trials are concentrated in Western European countries, with Germany, Belgium, France, and Poland hosting the majority of studies. Several trials are investigating GLP-2 analogues and similar medications, including HM15912, Glepaglutide, and Apraglutide, which work by promoting intestinal growth and improving nutrient absorption. Two studies examine how existing anticoagulant medications, Apixaban and Rivaroxaban, are absorbed in patients requiring long-term intravenous feeding, addressing an important safety concern for this population. Crofelemer represents a different therapeutic approach, focusing on regulating fluid secretion in the intestines. The studies vary in duration from 24 weeks to approximately 6 years, with several extension trials designed to evaluate long-term safety and effectiveness. These trials collectively aim to improve quality of life, reduce complications, and decrease the need for intravenous nutritional support in patients living with this challenging condition.
