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New treatment option for Short Bowel Syndrome
Official title A Study of Teduglutide in Chinese Adults With Short Bowel Syndrome
ClinicalTrials.gov ID: NCT06973304
What this study is testing
What is Teduglutide?
Teduglutide is an investigational medicine, given as an once-daily injection under the skin, being studied as a potential treatment for short bowel syndrome.
Also referred to as TAK-633, A16AX08.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Time commitment: about 65 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Males or females 18 years of age or older at the time of signing the informed consent.
- Intestinal failure due to SBS as a consequence of major intestinal resection (example, due to injury, volvulus, vascular disease, cancer, Crohn's...
- Has undergone intestinal resection resulting in at least 12 continuous months of PS dependency prior to signing the informed consent.
- Requires PS at least 3 times per week or at least 4 liters per week during the 2 weeks prior to baseline to meet caloric, fluid, or electrolyte needs...
- Has a stable PS requirement for at least 4 consecutive weeks immediately prior to the start of teduglutide treatment. Stability is defined as follows:
You likely can't join if
- Pregnant or lactating female.
- Participation in a clinical study using an experimental drug within 30 days or 5 half-lives, whichever is longer, prior to screening, or concurrent...
- Use of glucagon-like peptide (GLP)-2 or human growth hormone or analogs of these hormones within the past 6 months prior to the baseline visit.
- Use of octreotide, GLP-1 analogs, or dipeptidyl peptidase-4 inhibitors within 30 days prior to the baseline visit.
- Previous use of teduglutide.
- Active inflammatory bowel disease (IBD) or any participant with IBD requiring immunosuppressant therapy (example, azathioprine,anti-tumor necrosis...
See the full eligibility criteria
- Males or females 18 years of age or older at the time of signing the informed consent.
- Intestinal failure due to SBS as a consequence of major intestinal resection (example, due to injury, volvulus, vascular disease, cancer, Crohn's disease).
- Has undergone intestinal resection resulting in at least 12 continuous months of PS dependency prior to signing the informed consent.
- Requires PS at least 3 times per week or at least 4 liters per week during the 2 weeks prior to baseline to meet caloric, fluid, or electrolyte needs due to ongoing malabsorption.
- Has a stable PS requirement for at least 4 consecutive weeks immediately prior to the start of teduglutide treatment. Stability is defined as follows:
- Actual PS usage is similar to prescribed PS.
- Baseline (Visit 2) 48-hour intake (I)/output (O) volumes should fall within +-25% of the respective 48-hour I/O volumes at the last optimization visit.
- The 48-hour urine output volume must not be less than 2 liters and should not exceed 4 liters at the last optimization visit, the stabilization visit, and the baseline visit.
- Participants with a history of Crohn's disease must be in endoscopic remission for at least 12 weeks prior to the baseline visit.
- Pregnant or lactating female.
- Participation in a clinical study using an experimental drug within 30 days or 5 half-lives, whichever is longer, prior to screening, or concurrent participation in any other clinical study.
- Use of glucagon-like peptide (GLP)-2 or human growth hormone or analogs of these hormones within the past 6 months prior to the baseline visit.
- Use of octreotide, GLP-1 analogs, or dipeptidyl peptidase-4 inhibitors within 30 days prior to the baseline visit.
- Previous use of teduglutide.
- Active inflammatory bowel disease (IBD) or any participant with IBD requiring immunosuppressant therapy (example, azathioprine,anti-tumor necrosis factor [anti-TNF]) drugs) that had been introduced or changed within the...
- Intestinal malabsorption due to a genetic condition, such as cystic fibrosis, microvillus inclusion disease, familial adenomatous polyposis.
- Chronic intestinal pseudo-obstruction or severe dysmotility.
- Clinically significant intestinal stenosis or obstruction, or evidence of such on upper gastrointestinal (UGI)/small bowel follow-through (SBFT), within the past 6 months prior to the baseline visit.
- Major gastrointestinal (GI) surgical intervention, including significant intestinal resection, within the past 3 months (insertion of feeding tube, anastomotic ulcer repair, minor intestinal resections less than or...
- Unstable cardiac disease, (example, congestive heart failure, cyanotic disease, or congenital heart disease).
- Moderate or severe renal impairment, defined as creatinine clearance less than 50 milliliters per minute (mL/min).
- Currently diagnosed with cancer or a history of any cancer except surgically cured skin cancer within the past 5 years.
- Severe hepatobiliary disease including any of the following:
- Total bilirubin level at least 2 times the upper limit of normal (ULN), except for increased indirect (unconjugated) bilirubin in a patient with Gilbert's syndrome.
- AST at least 5\ ULN.
- ALT at least 5\ ULN
- Active clinically significant pancreatic disease, including clinical signs of pancreatitis associated with elevations in serum amylase or lipase at least 2\ ULN.
- More than 4 SBS-related or PS-related hospital admissions (example, central line-associated bloodstream infection, bowel obstruction, severe fluid/electrolyte disturbances) within the past 12 months prior to the...
- Unscheduled hospitalization within 30 days prior to screening.
- Non-herpetic viral diseases:
- Presence of hepatitis C virus (HCV) antibody and a positive confirmatory test result for HCV RNA (ribonucleic acid) (nucleic acid test or polymerase chain reaction).
- Presence of (Hepatitis B Surface Antigen Positive [HBsAg+]). For participants who are negative for HBsAg but are positive for either surface antibodies and/or core antibodies, hepatitis B virus (HBV) deoxyribonucleic...
- Positive results for human immunodeficiency virus (HIV) by serology, regardless of viral load.
- Any condition, disease, illness, or circumstance that in the investigator's opinion puts the participant at any undue risk, prevents completion of the study, or interferes with analysis of the study results. Example of...
The study team makes the final eligibility decision.
Where it's taking place
- Changping, Beijing Municipality, China
- Dongcheng, Beijing Municipality, China
- Nanjing, Jiangsu, China
- Siming, Xiamen, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 65 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Changping, Beijing Municipality, China; Dongcheng, Beijing Municipality, China; Nanjing, Jiangsu, China; Siming, Xiamen, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.