ong-term safety of apraglutide in short bowel syndrome

Phase 1

• Conditions: short bowel syndrome; MedDRA version: 20.1Level: PTClassification code 10049416Term: Short-bowel syndromeSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2020-005513-41-HU
• Lead Sponsor: VectivBio AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-17
• Last Update Posted: 29 July 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 have completed parent trials TA799-007 or TA799-013 and:
a. Did not meet any stopping criteria.
b. 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. 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.
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 visit.
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 Visit.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 84
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 70

Exclusion Criteria

1. Subject not capable of understanding or not willing to adhere to the trial visit schedules and other protocol requirements.
2. Judged not eligible by the Investigator or any other reason.

Study & Design

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