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-BE
• Lead Sponsor: VectivBio AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-29
• Last Update Posted: 15 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 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 74

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