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Pasireotide s.c. in Patients With Post-Bariatric Hypoglycaemia

Study acronym: PASIPHY
StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 5 months later Apr 2026 → Oct 29, 2026
See other at-risk trials from RECORDATI GROUP

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Apr 2026 to Oct 29, 2026
    • Eligibility criteria expanded, about 80 words
    • Secondary endpoints: details revised at 12 of 15 entries
    • Site details revised at 5 of 29 sites
  2. Trial status: Recruiting to Active, Not Recruitingv31 Show 4 more changesShow less
    • Enrollment target: estimated 72 to confirmed 93
    • Study sites: 31 to 29
    • Secondary endpoints: 28 to 15
    • Eligibility criteria expanded, about 5 words
  3. Site details revised at 1 of 31 sitesv30
  4. Primary completion date: Apr 2025 to Apr 2026v29
  5. Site contacts updated at 2 of 31 sitesv28
Show 26 earlier versionsHide 26 earlier versions
  1. Site contacts updated at 4 of 31 sitesv27
  2. Site details revised at 4 of 31 sitesv26
  3. Site details revised at 5 of 31 sitesv25
  4. Study sites: 32 to 31v24
  5. Site details revised at 1 of 32 sitesv23
  6. Site details revised at 2 of 32 sitesv22
  7. Study sites: 24 to 32v21
  8. Site contacts updated at 1 of 24 sitesv20
  9. Site contacts updated at 1 of 24 sitesv19
  10. Site contacts updated at 1 of 24 sitesv18
  11. Site details revised at 2 of 24 sitesv17
  12. Study sites: 20 to 24v16
  13. Primary endpoint revised
    • Eligibility criteria expanded, about 544 words
    • Secondary endpoints expanded, about 325 words
    • Site contacts updated at 19 of 20 sites
    v15
  14. Site details revised at 19 of 20 sitesv14
  15. Site details revised at 1 of 20 sitesv13
  16. Site details revised at 3 of 20 sitesv12
  17. Study sites: 19 to 20v11
  18. Site details revised at 2 of 19 sitesv10
  19. Study sites: 18 to 19v9
  20. Site details revised at 1 of 18 sitesv8
  21. Site details revised at 4 of 18 sitesv7
  22. Site contacts updated at 3 of 18 sitesv6
  23. Study sites: 19 to 18v5
  24. Study sites: 1 to 19
    • Eligibility criteria expanded, about 4 words
    v4
  25. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Oct 2023 to Jan 4, 2024
    v3
  26. Primary endpoint revisedv2
  1. 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 Total duration of trial participation for each participant with post-bariatric hypoglycemia will be a maximum of 59 weeks, with the following duration of trial periods * 19 weeks for the Core Phase. It is composed of: * a Screening period: a maximum of 3 weeks * a Run-in period (no treatment): 4 weeks * a Blinded Treatment Phase: 12 weeks * 36 weeks Extension Phase = an open-label Treatment period * 4 weeks for the safety follow-up period (without any treatment).
Trial Details
NCT Number NCT05928390
Lead Sponsor RECORDATI GROUP
Conditions
(from sponsor)		 Post-Bariatric Hypoglycemia
Enrollment 93 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov