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NCT06413368 · ClinicalTrials.gov registry record · Phase 2
Maralixibat in Patients With Cystic Fibrosis and Constipation
A Phase 2 study, sponsored by Children's Hospital Los Angeles.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
NCT06413368 is a Phase 2 study that is actively recruiting participants, run by Children's Hospital Los Angeles. The registered enrollment target is 20 participants.
The verdict
NCT06413368, a Phase 2 study, is actively recruiting participants, sponsored by Children's Hospital Los Angeles.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
Study Summary
Chronic constipation is common in children with cystic fibrosis (CF), likely due to impaired chloride channel function that reduces intestinal secretions. Standard osmotic laxatives often provide inadequate relief in this population. Maralixibat is an ileal bile acid transporter inhibitor (IBATi) that increases the amount of bile acids reaching the colon. Bile acids can enhance intestinal secretion, reduce transit time, and soften stool. This study will evaluate whether Maralixibat improves stool consistency in children with CF who experience constipation. We will enroll 20 children with CF and constipation, defined as a Bristol Stool Scale score \<4 for at least one week while on a stable laxative regimen. Each participant will receive Maralixibat for two weeks in addition to their usual laxatives. Families will record stool consistency and ease of defecation before and during treatment. The primary objective is to determine whether Maralixibat improves stool consistency to a Bristol Stool Scale score \>4. The secondary objective is to assess changes in ease of defecation using standardized questionnaires.
Interventions
- DRUG Maralixibat 9.5 MG/ML [Livmarli]
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2025-04-09 |
| Est. Completion | 2027-06-30 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06413368
The ClinicalTrials.gov registry entry for NCT06413368 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Hospital Los Angeles, which has 119 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Maralixibat 9.5 MG/ML [Livmarli] is the first listed.
NCT06413368 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06413368 about?
NCT06413368 is a clinical study titled "Maralixibat in Patients With Cystic Fibrosis and Constipation". Chronic constipation is common in children with cystic fibrosis (CF), likely due to impaired chloride channel function that reduces intestinal secretions. Standard osmotic laxatives often provide inadequate relief in this population. Maralixibat is an ileal bile acid transporter inhibitor (IBATi) t...
What is the current status of trial NCT06413368?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2025-04-09. Estimated completion is 2027-06-30.
What interventions are being tested in trial NCT06413368?
The interventions under investigation include: Maralixibat 9.5 MG/ML [Livmarli] (DRUG).
Who is sponsoring clinical trial NCT06413368?
This trial is sponsored by Children's Hospital Los Angeles, which has 119 total clinical trials registered on ClinicalTrials.gov.
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