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Open-label Extension Trial to Evaluate the Long-term Safety of Apraglutide in Short Bowel Syndrome.

Study acronym: STARS extend
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. 3 versions Re-verified since Oct 23, 2024, no change to tracked fieldsv7-v9
  2. Study sites revised (66)v6
  3. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 138 to confirmed 158
    • Study sites: 57 to 66
    v5
  4. Study sites: 38 to 57v4
  5. Primary and study completion dates: Jul 30, 2025 to Oct 30, 2027v3 Show 4 more changesShow less
    • Study sites: 8 to 38
    • Secondary endpoints: 9 to 14
    • Study description expanded, about 11 words
    • Eligibility criteria expanded, about 2 words
  6. Study sites: 1 to 8v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The primary objective of the trial is to assess long-term safety and tolerability of apraglutide in subjects with SBS-IF.
Trial Details
NCT Number NCT05018286
Lead Sponsor VectivBio AG
Conditions
(from sponsor)		 Short Bowel Syndrome
Related terms Intestinal Failure, Short Bowel Syndrome
Enrollment 158 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov