Trial · NCT03499249
N-Acetylcysteine in Biliary Atresia After Kasai Portoenterostomy
NCT03499249, Phase 2, Completed, Baylor College of Medicine; results first posted 2024-01-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. N-Acetylcysteine in Biliary Atresia After Kasai Portoenterostomy. Trials, record NCT03499249. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03499249
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- N-Acetylcysteine in Biliary Atresia After Kasai Portoenterostomy
- NCT number
- NCT03499249
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 13 participants, actual
- Lead sponsor
- Baylor College of Medicine
- Conditions
- Biliary Atresia
- Interventions
- N-Acetyl cysteine
- First posted
- 2018-04-17
- Last updated
- 2024-03-26
- Results first posted
- 2024-01-10
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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) | Within 24 weeks after KP | Expected is \~5% of participants based on historical controls (see protocol for summary of historical controls); a higher number is a better outcome |
| Secondary | 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) | 3 days after KP compared to baseline (before KP); 7 days after KP compared to baseline (before KP) | fold-change from baseline (ratio); a fold-change \<1 is a better outcome. |
| Secondary | Number of Patients Experiencing Sentinel Events in the First 2 Years of Life | First two years of life | Events include Nasogastric (NG) feeds or Total Parental Nutrition (TPN) initiation, Splenomegaly (based on ultrasound findings), Thrombocytopenia (platelets \<150,000/mm3), Ascites (recorded when diuretics were needed for fluid accumulation), GI bleed (varices documented by endoscopy), Portal hypertension (one of the following: ascites, or combination of splenomegaly and thrombocytopenia), and Liver transplant or death; units are number of patients, higher numbers are worse outcomes. |
| Secondary | Number of Patients With Adverse Events Possibly Related to NAC, Including Rash, Urticaria, Pruritus, Tachycardia, Hypotension, Vomiting, Edema, Anaphylaxis, and Intravenous Line Issues | Within four weeks after KP | Units are number of patients, higher number is worse outcome |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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) | Within 24 weeks after KP | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | 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) | 3 days after KP compared to baseline (before KP); 7 days after KP compared to baseline (before KP) | fold change over baseline | MEAN | |
| SECONDARY | Number of Patients Experiencing Sentinel Events in the First 2 Years of Life | First two years of life | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Patients With Adverse Events Possibly Related to NAC, Including Rash, Urticaria, Pruritus, Tachycardia, Hypotension, Vomiting, Edema, Anaphylaxis, and Intravenous Line Issues | Within four weeks after KP | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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) | N-Acetylcysteine Treatment | 0 | Participants | ||
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) | N-Acetylcysteine Treatment | AST 3 days after KP | 1.5 | Standard Deviation 0.5 | fold change over baseline |
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) | N-Acetylcysteine Treatment | AST 7 days after KP | 1.4 | Standard Deviation 0.4 | fold change over baseline |
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) | N-Acetylcysteine Treatment | ALT 3 days after KP | 3.3 | Standard Deviation 2.3 | fold change over baseline |
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) | N-Acetylcysteine Treatment | ALT 7 days after KP | 2.1 | Standard Deviation 0.5 | fold change over baseline |
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) | N-Acetylcysteine Treatment | GGT 3 days after KP | 0.9 | Standard Deviation 0.3 | fold change over baseline |
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) | N-Acetylcysteine Treatment | GGT 7 days after KP | 1.7 | Standard Deviation 0.9 | fold change over baseline |
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) | N-Acetylcysteine Treatment | Bc 3 days after KP | 1.3 | Standard Deviation 0.4 | fold change over baseline |
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) | N-Acetylcysteine Treatment | Bc 7 days after KP | 1.3 | Standard Deviation 0.4 | fold change over baseline |
| Number of Patients Experiencing Sentinel Events in the First 2 Years of Life | N-Acetylcysteine Treatment | NG feeds or TPN initiation | 4 | Participants |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | N-Acetylcysteine Treatment | 13 | |
| Overall Study | COMPLETED | N-Acetylcysteine Treatment | 12 | |
| Overall Study | NOT COMPLETED | N-Acetylcysteine Treatment | 1 |
Source ClinicalTrials.gov
Adverse events11
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Emesis with feeds | Gastrointestinal disorders | N-Acetylcysteine Treatment | 3 | 13 | 3 |
| other | Loss of an IV | Investigations | N-Acetylcysteine Treatment | 4 | 13 | 4 |
| other | Febrile illness | Infections and infestations | N-Acetylcysteine Treatment | 1 | 13 | 1 |
| other | AST 400 IU/L >pre-KP value | Hepatobiliary disorders | N-Acetylcysteine Treatment | 6 | 13 | 6 |
| other | GGT 400 IU/L >pre-KP value | Hepatobiliary disorders | N-Acetylcysteine Treatment | 8 | 13 | 8 |
| other | Conjugated bilirubin 3 mg/dL >pre-KP value | Hepatobiliary disorders | N-Acetylcysteine Treatment | 2 | 13 | 2 |
| other | Total bilirubin 5 mg/dL >pre-KP value | Hepatobiliary disorders | N-Acetylcysteine Treatment | 1 | 13 | 1 |
| serious | Febrile illness | Infections and infestations | N-Acetylcysteine Treatment | 2 | 13 | 2 |
| serious | ALT 700 IU/L >pre-KP value | Hepatobiliary disorders | N-Acetylcysteine Treatment | 1 | 13 | 1 |
| serious | INR >2.0 | Blood and lymphatic system disorders | N-Acetylcysteine Treatment | 1 | 13 | 1 |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | N-Acetylcysteine Treatment | 0 | 13 |
| Total, other adverse events | N-Acetylcysteine Treatment | 11 | 13 |
| Total, serious adverse events | N-Acetylcysteine Treatment | 5 | 13 |
Source ClinicalTrials.gov
Papers23
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03499249
GET https://conductscience.org/api/trials/v1/NCT03499249/papers?page=2