ong-term safety of apraglutide in short bowel syndrome

Phase 1

• Conditions: short bowel syndrome; MedDRA version: 20.1Level: PTClassification code: 10049416Term: Short-bowel syndrome Class: 100000004856; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: CTIS2023-510389-28-00
• Lead Sponsor: VectivBio AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-29
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 154

Inclusion Criteria

1. Males and females with a diagnosis of SBS-IF secondary to surgical resection of the small intestine, with CIC or stoma, who were trial subjects of TA799-007 or TA799-013 (parent trials) and: a. Did not meet any stopping criteria b. For those subjects who completed a parent trial, they have received a minimum of 70% of the planned doses in the trial (unless an AE precluded the subject from meeting this percentage; in this case, the Investigator will decide if the subject will benefit from enrolling in the trial) c. For those subjects who completed a parent trial, they have completed the last two scheduled visits of the parent trial. Subjects who were forced to withdraw from TA799-007 or TA799-013 for logistical reasons not related to the efficacy or safety of apraglutide (e.g., hospitalization for a car accident, coronavirus disease [COVID-19] pandemic, emergency surgery, etc.), which resulted in several consecutive missed doses, including the last 2 visits, may be eligible to participate in this trial upon approval by the Medical Monitor d. When the required number of trial-completed subjects is achieved in a parent trial, the remaining subjects still on treatment may prematurely discontinue the parent trial and roll over into TA799-012 (before completing all the parent trial visits). Criterion d” is not applicable to sites in France, 2. Able to give informed consent and agree to follow the details of participation as outlined in this protocol, 3. Women of childbearing potential must agree to use a highly effective method of contraception during the trial and for 4 weeks after the EOT/early termination/safety follow-up visit. Such methods include combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal); progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable); intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomized partner. To be considered sterilized or infertile, females must have undergone surgical sterilization (bilateral tubectomy, hysterectomy or bilateral ovariectomy) or be postmenopausal (defined as at least 12 months amenorrhea without an alternative medical cause, may be confirmed with follicle-stimulating hormone [FSH] test in case of doubt). Women who do not engage in heterosexual intercourse will be allowed to join the trial without contraception following a thorough discussion with the Investigator to determine if this is feasible for the subject. The following methods are not considered acceptable methods of contraception: calendar, ovulation, symptothermal, post-ovulation methods, withdrawal (coitus interruptus), spermicides only, and lactational amenorrhea method, 4. Male subjects with a female partner of childbearing potential must commit to practice methods of contraception and abstain from sperm donation during the trial and for 2 weeks after the EOT/early termination/safety follow-up visit. Nevertheless, if their partners are women of childbearing potential, they must agree to practice contraception and use a highly effective method of contraception during the trial and for 4 weeks after the EOT/early termination/safety follow-up visit. Such methods include combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal); progestogen-only hormonal cont

Exclusion Criteria

1. Subject not capable of understanding or not willing to adhere to the trial visit schedules and other protocol requirements, 2. Subject not undergoing a baseline colonoscopy (if anatomically feasible) or colonography and not having had all identified colonic or rectal polyps removed, 3. Judged not eligible by the Investigator for any other reason

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess long-term safety and tolerability of apraglutide in subjects with SBS-IF;Secondary Objective: To evaluate markers indicative of clinical effects of apraglutide;Primary end point(s): 1. Adverse events (AEs; system organ class, frequency and severity), 2. Occurrence of clinically relevant AEs of special interest (AESIs): o Injection site reactions o Gastrointestinal (GI) obstructions o Gallbladder, biliary and pancreatic disease o Fluid overload o Colorectal polyps o Malignancies, 3. Clinical chemistry, hematology, hemostasis and urinalysis, 4. Occurrence of clinically relevant changes in vital signs (systolic and diastolic blood pressure, heart rate), 5. Occurrence of clinically relevant changes in electrocardiogram (ECG; intervals and rhythm)