NCT06721871 · ClinicalTrials.gov record · last posted 2026-06-09
Ascending Doses of Crofelemer Powder for Oral Solution in Pediatric Microvillus Inclusion Disease (MVID)
StatusActive, Not Recruiting
PhasePhase 2/3
Started2025-05-01
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from the ClinicalTrials.gov record
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.
Amendment record
4 amendments on the ClinicalTrials.gov record
This ClinicalTrials.gov record has been amended 4 times since 2024-12-03; most recent amendment 2026-06-05. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history.
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2026-06-05
Status change Recruiting→Active, Not Recruitingv4
2025-06-09
Status change Not Yet Recruiting→Recruitingv3
| NCT Number |
NCT06721871 |
| Lead Sponsor |
Napo Pharmaceuticals, Inc.
|
| Conditions |
Microvillus Inclusion Disease, Congenital Disorders, Rare Diseases |
| Enrollment |
6 participants |
| Start Date |
2025-05-01 |
| Primary Completion |
2026-12 (estimated) |
| Study Completion |
2026-12 (estimated) |
| Updated on ClinicalTrials.gov |
2026-06-09 |