A Study of Teduglutide in Chinese Adults With Short Bowel Syndrome

Официальное название

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

Обзор

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.

Вмешательства

• Препарат Teduglutide
  Teduglutide 0.05 mg/kg SC injection.

Первичные конечные точки

• Percentage of Participants Who Achieved At Least 20 Percent (%) Reduction From Baseline in Weekly Parenteral Support (PS) Volume at Week 20 and Maintained Through Week 24 [Срок оценки: Up to Week 24]

Вторичные конечные точки (12)

• Absolute Change From Baseline in Weekly PS Volume up to Week 24 [Срок оценки: Baseline up to Week 24]
• Percent Change From Baseline in Weekly PS Volume up to Week 24 [Срок оценки: Baseline up to Week 24]
• Absolute Change From Baseline in Days Per Week of PS up to Week 24 [Срок оценки: Baseline up to Week 24]
• Percent Change From Baseline in Days Per Week of PS up to Week 24 [Срок оценки: Baseline up to Week 24]
• Number of Participants Who Achieved At Least 20% Reduction From Baseline in Weekly PS Volume at each visit [Срок оценки: Up to Week 24]
• Number of Participants With At Least a 20% Reduction From Baseline in Weekly PS at Week 20 and Maintained Through Week 24 [Срок оценки: Baseline, Week 20 and Week 24]
• Number of Participants With At Least a 2-liter Reduction From Baseline in Weekly PS at Week 20 and Maintained Through Week 24 [Срок оценки: Baseline, Week 20 and Week 24]
• Number of Participants who are able to Completely Wean off of PS support at Week 24 [Срок оценки: At Week 24]
• Time From First Dose to Time of Completely Weaning off of PS Support [Срок оценки: Up to Week 24]
• AUC0-inf: Area Under the Plasma Concentration-time Curve From Time 0 to Time of Infinity for Teduglutide [Срок оценки: Predose, 1, 2, 4, 6, 8, and 10 hours post-dose]
• AUC0-last: Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for Teduglutide [Срок оценки: Predose, 1, 2, 4, 6, 8, and 10 hours post-dose]
• Cmax: Maximum Observed Plasma Concentration for Teduglutide [Срок оценки: Predose, 1, 2, 4, 6, 8, and 10 hours post-dose]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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 past 6 months prior to the baseline visit.
• 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 equal to \[<=\] 10 centimeter \[cm\], or endoscopic procedure is allowed) prior to the baseline visit.
• 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 baseline visit.
• 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 acid (DNA) polymerase chain reaction will be performed; if any test result meets or exceeds detection sensitivity, the subject will be excluded.
• 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 potential disease state/illnesses that may be excluded are listed in the protocol.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 4 центра

• Beijing Tsinghua Changgung Hospital — Changping
• Peking Union Medical College Hospital — Dongcheng
• Affiliated Jinling Hospital, Medical School of Nanjing University — Нанкин
• Zhongshan Hospital, Xiamen University — Siming

Идентификаторы

NCT: NCT06973304 · TAK-633-3009

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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