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

NCT ID NCT06260566

Symptom relief Sponsor: Sanjiv Harpavat Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 12 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Oct 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

122 to 273 days

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 122-273 days of life at time of enrollment * Confirmed diagnosis of biliary atresia based on intraoperative cholangiogram * Able to tolerate oral nutrition and medications and not on continuous tube feeds * Anticipated inpatient admission of at least 4 days * Legal guardian(s) consent to study enrollment after understanding the risks and investigational nature of the study Exclusion Criteria: * Gestational age of \<32 weeks at birth * Inability or contraindication to taking oral nutrition * Neonatal intensive care unit admission * Short bowel, or other malabsorptive, syndrome * Decompensated liver disease (INR \> 1.3 despite vitamin K administration) * Active respiratory infection * Severe concurrent illnesses that would interfere with the conduct and/or results of the study * Concurrent participation in another drug trial

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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

How to take part

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

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More trials for these conditions

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