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NCT06721871 · ClinicalTrials.gov registry record · Phase 2
Ascending Doses of Crofelemer Powder for Oral Solution in Pediatric Microvillus Inclusion Disease (MVID)
A Phase 2 study of Rare Diseases and Congenital Disorders, sponsored by Napo Pharmaceuticals.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 12
- Enrollment target
- 3
- Study locations
NCT06721871: Recruiting Phase 2 study of Rare Diseases and Congenital Disorders, sponsored by Napo Pharmaceuticals.
NCT06721871 is a Phase 2 study of Rare Diseases and Congenital Disorders that is actively recruiting participants, run by Napo Pharmaceuticals. The registered enrollment target is 12 participants, below the 17,474-participant average among 7 other Rare Diseases trials with a reported enrollment target (100% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06721871, a Phase 2 study of Rare Diseases and Congenital Disorders, is actively recruiting participants, sponsored by Napo Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 12 participants
- Enrollment target
- 3
- Study locations
Study Summary
a 32-week 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
Primary Outcome
Incidence of Adverse Events and Serious Adverse Events
Conditions Studied
Interventions
- DRUG Crofelemer Powder for Oral Solution
- DRUG Placebo Powder for Oral Solution
Study Locations (3)
Other
- UOS Gastroenterolgia e Riabilitazione nutrizionale Piazza Sant' Onofrio 4 - Rome
- Al Jalila Children's Hospital - Dubai
Massachusetts
- Boston Children's Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2025-05-01 |
| Est. Completion | 2026-03 |
| Phase | Phase 2 |
What NCT06721871 shows while recruiting
NCT06721871 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 17,474-participant average among 7 other Rare Diseases trials with a reported enrollment target (100% lower).
The record links to 3 conditions, with Rare Diseases appearing as the primary indexed condition, and to 2 interventions - of which Crofelemer Powder for Oral Solution is the first listed.
NCT06721871 reports a single indexed study location in Other, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT06721871 about?
NCT06721871 is a clinical study titled "Ascending Doses of Crofelemer Powder for Oral Solution in Pediatric Microvillus Inclusion Disease (MVID)". a 32-week 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 T...
What is the current status of trial NCT06721871?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2025-05-01. Estimated completion is 2026-03.
What conditions does trial NCT06721871 study?
This clinical trial studies the following conditions: Rare Diseases, Congenital Disorders, Microvillus Inclusion Disease.
What interventions are being tested in trial NCT06721871?
The interventions under investigation include: Crofelemer Powder for Oral Solution (DRUG), Placebo Powder for Oral Solution (DRUG).
Who is sponsoring clinical trial NCT06721871?
This trial is sponsored by Napo Pharmaceuticals, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06721871 being conducted?
This trial has 3 study locations across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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