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

NCT06721871 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-06-12

No results posted yet for this 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

Conditions

  • Microvillus Inclusion Disease
  • Congenital Disorders
  • Rare Diseases

Interventions

DRUG

Crofelemer Powder for Oral Solution

Crofelemer Powder for Oral Solution

DRUG

Placebo Powder for Oral Solution

Matching Placebo Powder for Oral Solution

Sponsors & Collaborators

  • Napo Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Lissette Jimenez, MD, MPH · Boston Children's Hospital

  • Pravin Chaturvedi, PhD · Napo Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
3 Months
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-01
Primary Completion
2026-02-28
Completion
2026-03-31
FDA Drug
Yes

Countries

  • United States
  • Italy
  • United Arab Emirates

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06721871 on ClinicalTrials.gov