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NCT03499249 · ClinicalTrials.gov registry record · Phase 2
N-Acetylcysteine in Biliary Atresia After Kasai Portoenterostomy
A Phase 2 study, sponsored by Baylor College of Medicine.
- Completed
- Registry status
- Phase 2
- Development phase
- 13
- Enrollment target
NCT03499249 is a Phase 2 study that has completed, run by Baylor College of Medicine. The registered enrollment target is 13 participants.
The verdict
NCT03499249, a Phase 2 study, has completed, sponsored by Baylor College of Medicine.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 13 participants
- Enrollment target
Study Summary
Biliary atresia (BA) is a devastating liver disease of infancy, characterized by bile duct obstruction leading to liver fibrosis, cirrhosis, and eventual need for transplantation in most cases. BA is treated with Kasai portoenterostomy (KP). KPs can achieve bile drainage and improve outcomes. However, even with standard evidence of "good bile flow," bile flow rarely normalizes completely and liver disease continues to progress. In this study, the investigators test whether intravenous N-acetylcysteine (NAC) can improve bile flow after KP. The rationale is that NAC leads to synthesis of glutathione, which is a powerful stimulator of bile flow. The primary objective is to determine whether NAC normalizes total serum bile acid (TSBA) concentrations within 24 weeks of KP. Achieving normal TSBAs is uncommon with current standard-of-care, and is predicted to be associated with better long-term outcomes. The secondary objectives are to describe how other parameters commonly followed in BA change with NAC therapy, as well as report adverse events occurring with therapy and in the first two years of life. This study follows the "minimax" Phase 2 clinical trial design.
Interventions
- DRUG N-Acetyl cysteine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2018-05-18 |
| Est. Completion | 2024-03-23 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03499249
The ClinicalTrials.gov registry entry for NCT03499249 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baylor College of Medicine, which has 616 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which N-Acetyl cysteine is the first listed.
NCT03499249 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03499249 about?
NCT03499249 is a clinical study titled "N-Acetylcysteine in Biliary Atresia After Kasai Portoenterostomy". Biliary atresia (BA) is a devastating liver disease of infancy, characterized by bile duct obstruction leading to liver fibrosis, cirrhosis, and eventual need for transplantation in most cases. BA is treated with Kasai portoenterostomy (KP). KPs can achieve bile drainage and improve outcomes. Howeve...
What is the current status of trial NCT03499249?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 13 participants. The study started on 2018-05-18. Estimated completion is 2024-03-23.
What interventions are being tested in trial NCT03499249?
The interventions under investigation include: N-Acetyl cysteine (DRUG).
Who is sponsoring clinical trial NCT03499249?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
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