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Clinical Trials/EUCTR2020-005513-41-DE
EUCTR2020-005513-41-DEActive, not recruitingPhase 1

An open-label extension trial to evaluate the long-term safety of apraglutide in short bowel syndrome

VectivBio AG0 sites154 target enrollmentStarted: May 21, 2021Last updated:
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Conditions

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Enrollment
154
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

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 desease (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).
  • •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.
  • •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 followup 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 76
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 62

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.

Investigators

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