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Study of Safety, Tolerability and Clinical Outcomes of Egaten in Fascioliasis Patients (6 Years of Age or Older).

StatusCompleted
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Results posted: Oct 6, 2026 Primary endpoint revised · Eligibility criteria expanded, about 7 words · Secondary endpoints: 3 to 4 · 2 more Show 5 more changesShow less
    • Primary endpoint revised
    • Eligibility criteria expanded, about 7 words
    • Secondary endpoints: 3 to 4
    • Study description expanded, about 164 words
    • Site details revised at 4 of 10 sites
  2. 3 versions Re-verified since Apr 30, 2026, no change to tracked fieldsv31-v33
  3. Trial completed Primary and study completion dates changed from estimate of Mar 29, 2026 to Mar 27, 2026v30 Show 1 more changeShow less
    • Primary and study completion dates changed from estimate of Mar 29, 2026 to Mar 27, 2026
  4. 2 versions Re-verified since Feb 19, 2026, no change to tracked fieldsv28-v29
  5. Enrollment target: 299 to 301v27
Show 25 earlier versionsHide 25 earlier versions
  1. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 300 to confirmed 299 · Primary and study completion dates: May 13, 2026 to Mar 29, 2026 · Site details revised at 10 of 10 sitesv26 Show 3 more changesShow less
    • Enrollment target: estimated 300 to confirmed 299
    • Primary and study completion dates: May 13, 2026 to Mar 29, 2026
    • Site details revised at 10 of 10 sites
  2. Primary and study completion dates: Dec 10, 2026 to May 13, 2026 Site details revised at 3 of 10 sitesv25 Show 1 more changeShow less
    • Site details revised at 3 of 10 sites
  3. Study sites: 9 to 10v24
  4. Study sites: 6 to 9v23
  5. Primary and study completion dates: Dec 9, 2026 to Dec 10, 2026v22
  6. Primary and study completion dates: Mar 18, 2026 to Dec 9, 2026v21
  7. Re-verified, no change to tracked fieldsv20
  8. Site details revised at 1 of 6 sitesv19
  9. Re-verified, no change to tracked fieldsv18
  10. Site details revised at 1 of 6 sitesv17
  11. Primary completion date: Nov 19, 2025 to Mar 18, 2026 Completion date: Mar 19, 2026 to Mar 18, 2026v16 Show 1 more changeShow less
    • Completion date: Mar 19, 2026 to Mar 18, 2026
  12. Study sites: 5 to 6v15
  13. Study sites: 4 to 5v14
  14. Re-verified, no change to tracked fieldsv13
  15. Study sites: 2 to 4v12
  16. Study sites: 1 to 2v11
  17. 3 versions Re-verified since Apr 19, 2022, no change to tracked fieldsv8-v10
  18. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Completion date: Feb 5, 2026 to Mar 19, 2026 · Start date changed from estimate of Jan 17, 2022 to Feb 11, 2022v7 Show 3 more changesShow less
    • Study sites: 0 to 1
    • Completion date: Feb 5, 2026 to Mar 19, 2026
    • Start date changed from estimate of Jan 17, 2022 to Feb 11, 2022
  19. Start date: Oct 29, 2021 to Jan 17, 2022 Completion date: Nov 19, 2025 to Feb 5, 2026v6 Show 1 more changeShow less
    • Completion date: Nov 19, 2025 to Feb 5, 2026
  20. Primary and study completion dates: May 21, 2025 to Nov 19, 2025 Start date: Oct 21, 2021 to Oct 29, 2021v5 Show 1 more changeShow less
    • Start date: Oct 21, 2021 to Oct 29, 2021
  21. Start date: Jul 5, 2021 to Oct 21, 2021 Primary completion date: May 8, 2025 to May 21, 2025 · Completion date: May 23, 2025 to May 21, 2025v4 Show 2 more changesShow less
    • Primary completion date: May 8, 2025 to May 21, 2025
    • Completion date: May 23, 2025 to May 21, 2025
  22. Start date: Jan 29, 2021 to Jul 5, 2021 Completion date: May 8, 2025 to May 23, 2025v3 Show 1 more changeShow less
    • Completion date: May 8, 2025 to May 23, 2025
  23. Start date: Sep 29, 2020 to Jan 29, 2021 Primary and study completion dates: May 19, 2025 to May 8, 2025v2 Show 1 more changeShow less
    • Primary and study completion dates: May 19, 2025 to May 8, 2025
  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.
Novartis
555 trials monitored
See 31 trials at risk
The study evaluated safety and tolerability along with clinical outcomes of Egaten administered as per the FDA approved dosing regimen of 2 doses of 10 mg/kg (given approximately 12 hours apart) in Fascioliasis participants (≥ 6 years of age).
Trial Details
NCT Number NCT04230148
Lead Sponsor Novartis Pharmaceuticals
Conditions Fascioliasis
Enrollment 301 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov