Can a common antioxidant help babies with a rare liver disease? first safety trial begins

NCT ID NCT06260566

Not yet recruiting Symptom relief Sponsor: Sanjiv Harpavat Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This early-phase study tests whether infants with biliary atresia can tolerate oral N-Acetylcysteine (NAC) mixed into applesauce. Twelve infants will first receive plain applesauce, then NAC at increasing doses. The goal is to see if they can keep the medicine down without vomiting. If successful, this could lead to larger studies on NAC as a treatment to improve bile flow after Kasai surgery.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: N-Acetylcysteine (NAC) given orally mixed with applesauce
What this could lead to: If NAC is well-tolerated, it could pave the way for larger studies testing whether it helps improve bile flow after Kasai surgery in infants with biliary atresia.
What could go wrong: This is a very early phase 1 trial with only 12 infants, focused on tolerability, not effectiveness. NAC may cause vomiting or other side effects, and even if tolerated, it may not improve the disease.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for BILIARY ATRESIA are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

biliary atresia cholestasis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

BILIARY ATRESIA

More trials for these conditions

Other studies related to the condition(s) this trial covers.