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Ascending Doses of Crofelemer Powder for Oral Solution in Pediatric Microvillus Inclusion Disease (MVID)

StatusActive, Not Recruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Phase: Phase 2 to Phase 2/3 Primary completion date: Feb 2026 to Dec 2026 · Trial status: Recruiting to Active, Not Recruiting · Enrollment target: estimated 12 to confirmed 6 · 7 morev5 Show 10 more changesShow less
    • Primary completion date: Feb 2026 to Dec 2026
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 12 to confirmed 6
    • Completion date: Mar 2026 to Dec 2026
    • Eligibility criteria expanded, about 9 words
    • Secondary endpoints: 6 to 7
    • Primary endpoints revised (3)
    • Study description expanded, about 46 words
    • Site details revised at 3 of 3 sites
    • Publications: 26 to 30

    See this version in full on ClinicalTrials.gov ↗

  2. Trial status: Not Yet Recruiting to Recruiting Primary completion date: Dec 2025 to Feb 2026 · Start date changed from estimate of Apr 15, 2025 to May 1, 2025 · Site details revised at 3 of 3 sitesv4 Show 3 more changesShow less
    • Primary completion date: Dec 2025 to Feb 2026
    • Start date changed from estimate of Apr 15, 2025 to May 1, 2025
    • Site details revised at 3 of 3 sites
  3. Start date: Mar 15, 2025 to Apr 15, 2025v3
  4. Start date: Jan 2025 to Mar 15, 2025v2
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
A study that will evaluate the safety, tolerability and preliminary efficacy of multiple ascending doses of crofelemer, compared to placebo, using a randomized cross-over design within each dose level, when administered to participants with MVID receiving parenteral support (PS, defined as TPN with or without supplementary IV fluid requirements). Blinded study drug will be administered as a novel crofelemer formulation, Crofelemer Powder for Oral Solution, or a matching placebo powder formulation for oral solution. Assigned study drug will be reconstituted and administered orally (or enterally) three times daily (TID) as a concentrated liquid formulation in each of the three dose levels.
Trial Details
NCT Number NCT06721871
Lead Sponsor Napo Pharmaceuticals, Inc.
Conditions Microvillus Inclusion Disease, Congenital Disorders, Rare Diseases
Enrollment 6 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov