Actively Recruiting
An Open-label, Phase 3 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of 0.05 mg/kg/Day Subcutaneous Teduglutide Following Treatment of Short Bowel Syndrome for 24 Weeks in Chinese Adults Who Are Dependent on Parenteral Support
Led by Takeda · Updated on 2025-07-09
13
Participants Needed
4
Research Sites
24 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate how well teduglutide works in Chinese adults with short bowel syndrome (SBS) who depend on parenteral support. The study will assess teduglutide's ability to reduce the amount of parenteral support needed and will explore how the body absorbs, processes, and eliminates the medication. The trial is a phase 3, open-label study sponsored by Takeda focused on adults with SBS who have required parenteral support for at least 12 months. Participants will receive a daily subcutaneous injection of teduglutide at a dose of 0.05 mg per kilogram of body weight. The injection will be administered once daily into one of the four quadrants of the abdomen, thigh, or arm for a total of 24 weeks. After the treatment period, participants will be monitored for safety for an additional 24 weeks. Throughout the study, participants will be involved for approximately 65 weeks in total. Researchers will measure the reduction in weekly parenteral support volume, among other outcomes. They will also monitor teduglutide blood levels, antibody responses, urine output, body weight, and body mass index. Safety will be closely observed from the first dose through the follow-up period to understand any adverse events.
CONDITIONS
Brief Title
A Study of Teduglutide in Chinese Adults With Short Bowel Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males or females 18 years of age or older at the time of signing the informed consent.
- Intestinal failure due to short bowel syndrome caused by major intestinal resection.
- At least 12 continuous months of dependency on parenteral support before signing consent.
- Requires parenteral support at least 3 times per week or at least 4 liters per week during the 2 weeks before baseline.
- Has had a stable parenteral support requirement for at least 4 weeks before starting teduglutide treatment.
- Participants with Crohn's disease must be in endoscopic remission for at least 12 weeks before baseline.
You will not qualify if you...
- Pregnant or lactating females.
- Participation in another clinical study with an experimental drug within 30 days or 5 half-lives before screening.
- Use of glucagon-like peptide-2 or human growth hormone or their analogs within 6 months before baseline.
- Use of octreotide, GLP-1 analogs, or dipeptidyl peptidase-4 inhibitors within 30 days before baseline.
- Previous use of teduglutide.
- Active inflammatory bowel disease requiring immunosuppressant therapy or recent changes in such therapy within 6 months before baseline.
- Intestinal malabsorption due to genetic conditions like cystic fibrosis or microvillus inclusion disease.
- Chronic intestinal pseudo-obstruction or severe dysmotility.
- Significant intestinal stenosis or obstruction within 6 months before baseline.
- Major gastrointestinal surgery within 3 months before baseline, with some minor exceptions.
- Unstable cardiac disease.
- Moderate or severe kidney impairment (creatinine clearance less than 50 mL/min).
- Current cancer diagnosis or history of cancer within past 5 years except cured skin cancer.
- Severe liver disease as defined by specific lab criteria.
- Active pancreatic disease including pancreatitis with elevated enzymes.
- More than 4 hospital admissions related to SBS or parenteral support in past 12 months.
- Unscheduled hospitalization within 30 days before screening.
- Positive tests for hepatitis B, hepatitis C, or HIV.
- Any condition that poses undue risk or would interfere with study completion or results analysis.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 weeks
Participants receive daily subcutaneous injections of teduglutide for their short bowel syndrome.
Daily injections with multiple visits for assessments during treatment
Duration - Up to 24 weeks after treatment
Participants are monitored for safety and long-term outcomes after treatment ends.
Visits at Week 24 and Week 48 for safety and efficacy assessments
Trial Site Locations
Total: 4 locations
1
Beijing Tsinghua Changgung Hospital
Changping, Beijing Municipality, China, 102218
Actively Recruiting
2
Peking Union Medical College Hospital
Dongcheng, Beijing Municipality, China, 100730
Actively Recruiting
3
Affiliated Jinling Hospital, Medical School of Nanjing University
Nanjing, Jiangsu, China, 210016
Actively Recruiting
4
Zhongshan Hospital, Xiamen University
Siming, Xiamen, China, 361004
Actively Recruiting
Research Team
T
Takeda Contact
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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