← Back to Search

Mucolytic Agent

N-Acetyl cysteine for Biliary Atresia

Phase 2
Waitlist Available
Led By Sanjiv Harpavat, MD. PhD
Research Sponsored by Baylor College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age less than or equal to 90 days at time of KP (standard age range in which KPs are performed)
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up first two years of life
Awards & highlights

Study Summary

This trial is testing whether N-acetylcysteine can improve bile flow after Kasai portoenterostomy in infants with biliary atresia.

Who is the study for?
This trial is for infants up to 90 days old diagnosed with Biliary Atresia who've had a Kasai procedure at Texas Children's Hospital. They must not have severe liver, respiratory, kidney or other serious health issues. Parental consent is required.Check my eligibility
What is being tested?
The study tests if intravenous N-Acetylcysteine (NAC) can improve bile flow in infants after the Kasai surgery for Biliary Atresia by increasing glutathione levels. It aims to normalize total serum bile acid concentrations within six months post-surgery.See study design
What are the potential side effects?
While specific side effects of NAC are not detailed here, common ones may include allergic reactions, gastrointestinal symptoms like nausea or vomiting, and possible risk of infection due to IV administration.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 90 days old or younger.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~first two years of life
This trial's timeline: 3 weeks for screening, Varies for treatment, and first two years of life for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Patients With Biliary Atresia (BA) Achieving Total Serum Bile Acids Less Than or Equal to 10 *U*Mol/L Within 24 Weeks of Kasai Portoenterostomy (KP)
Secondary outcome measures
Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Gamma-glutamyltransferase (GGT) Fold, and Conjugated Bilirubin (Bc) Change Above Baseline at 3 Days and 7 Days After KP (During Treatment)
Number of Patients Experiencing Sentinel Events in the First 2 Years of Life
Number of Patients With Adverse Events Possibly Related to NAC, Including Rash, Urticaria, Pruritus, Tachycardia, Hypotension, Vomiting, Edema, Anaphylaxis, and Intravenous Line Issues

Trial Design

1Treatment groups
Experimental Treatment
Group I: N-Acetylcysteine TreatmentExperimental Treatment1 Intervention
Will receive continuous intravenous NAC therapy (6.25 mg/kg/hour of 10 mg/ml solution, or 0.625 ml/kg/hour, to give 150 mg/kg/day), starting within 24 hours of completion of KP and lasting for a total of 7 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cysteine
FDA approved

Find a Location

Who is running the clinical trial?

Baylor College of MedicineLead Sponsor
997 Previous Clinical Trials
6,002,006 Total Patients Enrolled
2 Trials studying Biliary Atresia
29 Patients Enrolled for Biliary Atresia
Sanjiv Harpavat, MD. PhDPrincipal InvestigatorBaylor College of Medicine

Media Library

N-Acetyl cysteine (Mucolytic Agent) Clinical Trial Eligibility Overview. Trial Name: NCT03499249 — Phase 2
Biliary Atresia Research Study Groups: N-Acetylcysteine Treatment
Biliary Atresia Clinical Trial 2023: N-Acetyl cysteine Highlights & Side Effects. Trial Name: NCT03499249 — Phase 2
N-Acetyl cysteine (Mucolytic Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03499249 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many volunteers are taking part in this research project?

"This clinical study is no longer recruiting participants. Originally posted on May 18th 2018, it was last updated on August 1st 2022. If searching for other trials, there are currently 12 studies enrolling patients with biliary atresia and 24 involving N-Acetyl cysteine."

Answered by AI

Is N-Acetyl cysteine a consequence-free supplement?

"Our team rated N-Acetyl cysteine with a score of 2 since it is still in its second clinical phase, suggesting that while safety information exists, there are not yet any results confirming its efficacy."

Answered by AI

Are there any unfilled openings in this research program?

"Per the information held on clinicaltrials.gov, this specific medical trial is not actively seeking participants at present. Initially posted on May 18th 2018 and last updated August 1st 2022, it has already concluded its recruitment process; however, there are 36 other studies with open enrolment opportunities available now."

Answered by AI

What eligibility criteria have been established for potential participants in this clinical investigation?

"This clinical study is soliciting 16 infants between 0 and 90 days old with a biliary atresia diagnosis confirmed by cholangiography, who have had their Kasai procedure performed at Texas Children's Hospital in the Texas Medical Center. The legal guardian(s) must also agree to participate after being informed of all associated risks and understand that this trial is experimental in nature."

Answered by AI

Is participation in this medical research restricted to individuals over a certain age?

"This clinical trial is specifically seeking out participants aged 0 days to 90 days. For those outside of the specified age range, there are 18 trials targeting people under 18 and 20 for seniors over 65."

Answered by AI
Recent research and studies
~2 spots leftby Mar 2025