Actively Recruiting
A Study of Teduglutide in Chinese Adults With Short Bowel Syndrome
Led by Takeda · Updated on 2025-07-09
13
Participants Needed
4
Research Sites
108 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The main aim of the study is to assess how well teduglutide works over 24 weeks in Chinese adult participants with short bowel syndrome (SBS) who need parenteral support and to see how much it can reduce the amount of parenteral support and understand how the body absorbs, processes, and gets rid of teduglutide. Participants will receive a daily injection of teduglutide under the skin for 24 weeks. Safety of teduglutide will be checked for 24 weeks after treatment. Participants will be in the study for about 65 weeks.
CONDITIONS
Official Title
A Study of Teduglutide in Chinese Adults With Short Bowel Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older at consent
- Intestinal failure due to short bowel syndrome from major intestinal resection
- At least 12 continuous months of parenteral support dependency before consent
- Requires parenteral support at least 3 times per week or 4 liters per week in the 2 weeks before baseline
- Stable parenteral support needs for at least 4 consecutive weeks before treatment
- Participants with Crohn's disease must have been in endoscopic remission for at least 12 weeks before baseline
You will not qualify if you...
- Pregnant or breastfeeding women
- Participation in another clinical study with experimental drugs within 30 days or 5 half-lives before screening
- Use of GLP-2, human growth hormone, or their analogs within 6 months before baseline
- Use of octreotide, GLP-1 analogs, or DPP-4 inhibitors within 30 days before baseline
- Previous use of teduglutide
- Active inflammatory bowel disease or recent changes in immunosuppressant therapy within 6 months before baseline
- Intestinal malabsorption caused by genetic conditions such as cystic fibrosis or familial adenomatous polyposis
- 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 (minor procedures allowed)
- Unstable heart disease
- Moderate or severe kidney impairment (creatinine clearance below 50 mL/min)
- Current cancer or history of cancer except cured skin cancer within 5 years
- Severe liver disease with elevated bilirubin or liver enzymes
- Active pancreatic disease with elevated amylase or lipase
- More than 4 hospital admissions related to short bowel syndrome or parenteral support in the past year
- Unscheduled hospitalization within 30 days before screening
- Positive tests for hepatitis B or C, or HIV infection
- Any condition that poses undue risk or interferes with study completion or results analysis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
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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