Teduglutide for Short Bowel Syndrome

Not currently recruiting at 108 trial locations

Overseen By Shire Contact

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Shire

Must be taking: Parenteral nutrition

Must not be taking: GLP-2 analogs

Disqualifiers: Blinded trial participation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 10 years

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to study the long-term safety and effects of teduglutide, a treatment for individuals with short bowel syndrome (SBS). SBS occurs when the body cannot absorb enough nutrients due to a missing or damaged part of the small intestine. The research compares outcomes between those treated with teduglutide and those who are not. It is suitable for individuals diagnosed with SBS who have relied on IV nutrition support for at least six months. As a Phase 4 trial, this research seeks to understand how the already FDA-approved and effective treatment benefits more patients.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, it does mention that participants should not have been exposed to other GLP-2 analogs besides teduglutide.

What is the safety track record for teduglutide?

Research has shown that teduglutide is generally well-tolerated by people with short bowel syndrome (SBS). Studies report the most common side effects as stomach pain, bloating, and a sore throat. While these can be uncomfortable, they are usually manageable.

Long-term studies gathered safety information from patients over an average of about 83 weeks. The findings indicated that the treatment did not cause many serious problems, with most side effects being mild to moderate.

Overall, teduglutide is considered to have a reliable safety record. For those with SBS considering treatment options, this evidence suggests that teduglutide might be a safe choice. It is important to discuss with a doctor what is best for individual needs. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Teduglutide is unique because it specifically targets the underlying issues of Short Bowel Syndrome (SBS). Unlike traditional treatments that primarily focus on managing symptoms and nutritional support, teduglutide works by mimicking a natural hormone called GLP-2, which helps the intestine absorb more nutrients and fluids. This can potentially reduce patients' dependence on intravenous nutrition, improving their quality of life significantly. Researchers are excited about teduglutide because it offers a more direct approach to enhancing intestinal function, rather than just addressing the symptoms.

What evidence suggests that teduglutide might be an effective treatment for short bowel syndrome?

Research has shown that teduglutide effectively treats short bowel syndrome (SBS). In one study, 85% of patients responded well to the treatment, and 24% stopped receiving nutritional support through their veins after six months. Another study found that patients taking teduglutide required significantly less intravenous nutrition over ten years compared to those not taking the drug. Additionally, some patients demonstrated a 40% early response rate, with a notable reduction in their need for nutritional support. These findings suggest that teduglutide can help many people with SBS rely less on intravenous nutrition. ^{6 7 8 9 10}

Who Is on the Research Team?

Study Director

Principal Investigator

Shire

Are You a Good Fit for This Trial?

Inclusion Criteria

Male and female participants, of any age, with a diagnosis of short bowel syndrome (SBS).

Signed informed consent and medical records release by the participant or a legally acceptable representative

Participants who have never received teduglutide treatment must be on parenteral nutrition (PN)/intravenous (IV) fluids support for at least 6 months at the time of enrollment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are observed for long-term safety and clinical outcomes while being treated with teduglutide or not

10 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Teduglutide

Who Is Running the Clinical Trial?

Shire

Lead Sponsor

Trials

457

Recruited

96,000+

Pierre S. Sayad

Shire

Chief Medical Officer

MD from Loma Linda University

Flemming Ornskov

Shire

Chief Executive Officer since 2013

PhD in Medicine from Aarhus University

Takeda Development Center Americas, Inc.

Industry Sponsor

Trials

58

Recruited

10,800+

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0899900724002892

Forty-eight months outcomes of teduglutide treatment in ... Data relative to short-term clinical outcomes demonstrate that 4 of 10 (40%) patients were early responders to TED therapy, defined as a >20% reduction in PS ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31932048/

Six-month outcomes of teduglutide treatment in adult ... Results: At week 24, 85% of patients were responders and 24% had been weaned off PS, with a 51% reduction of PS needs and 1.5 ± 0.2 days off PS per week. ...

3. clinicalnutritionjournal.com clinicalnutritionjournal.com/article/S0261-5614(25)00027-5/fulltext

Real-world experience of Teduglutide use in adults with ... Controls showed higher percentages of patients deceased or lost to follow up. Centers with ≥10 patients treated with Teduglutide showed higher ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT00798967

NCT00798967 | Study of Teduglutide Effectiveness in ... Comparison of subjects treated with teduglutide to placebo who achieve a 20 to 100% reduction from baseline in weekly parenteral nutrition/intravenous fluid (PN ...

5. healio.com healio.com/news/gastroenterology/20250522/teduglutide-shows-longterm-efficacy-in-short-bowel-syndromeassociated-intestinal-failure

Teduglutide shows long-term efficacy in short bowel ... Patients treated with teduglutide had significant reductions in parenteral nutrition/IV fluid needs over 10 years vs. untreated patients.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8647158/

Safety Findings in Pediatric Patients During Long‐Term ... Safety data were pooled from 4 clinical trials of teduglutide in children with SBS–IF, including a median of 83 weeks of prospective follow‐up.

7. journals.lww.com journals.lww.com/transplantjournal/fulltext/2023/07001/62__long_term_safety_analysis_of_teduglutide.58.aspx

62: Long-term safety analysis of teduglutide treatment in ... Methods: Safety data were compared between 'ever-treated' patients who received standard of care treatment (SOC) and TED, and 'never-treated' patients who ...

8. frontiersin.org frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2024.1404658/full

The real-world analysis of adverse events with teduglutide Teduglutide is generally considered safe and reliable, with the most frequent side effects being abdominal pain, abdominal distension, and nasopharyngitis (Pape ...

9. clinicalnutritionespen.com clinicalnutritionespen.com/article/S2405-4577(22)00631-3/fulltext

Long-Term Safety Analysis Of Teduglutide Treatment In ... Methods: We compared long-term safety between patients treated with TED ('ever-treated') vs those treated with standard of care and never exposed to TED ...

10. aspenjournals.onlinelibrary.wiley.com aspenjournals.onlinelibrary.wiley.com/doi/10.1002/jpen.1690

Safety and Efficacy of Teduglutide in Pediatric Patients With ... Data collected at each visit included predefined safety parameters, vital signs, blood samples, urine and stool output, body weight, body mass ...