Trial · NCT00896025
Study of N-Acetylcysteine in Acute Liver Failure (ALF)
NCT00896025, Phase 4, Terminated, University of Texas Southwestern Medical Center; results first posted 2014-01-29
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of N-Acetylcysteine in Acute Liver Failure (ALF). Trials, record NCT00896025. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00896025
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of N-Acetylcysteine in Acute Liver Failure (ALF)
- NCT number
- NCT00896025
- Status
- Terminated
- Phases
- Phase 4
- Enrollment
- 255 participants, actual
- Lead sponsor
- University of Texas Southwestern Medical Center
- Conditions
- Acute Liver Failure, Fulminant Hepatic Failure
- Interventions
- N-acetylcysteine
- First posted
- 2009-05-11
- Last updated
- 2020-06-01
- Results first posted
- 2014-01-29
- Limitations and caveats
- Early termination lead to zero subjects analyzed.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Survival Rate With or Without Transplant | 3 Weeks | The primary outcome is to compare all patients who survive (with or without transplant) to those who die. |
| Primary | Survival Rate With or Without Transplant | 1-year follow-up | The primary outcome is to compare all patients who survive (with or without transplant) to those who die. |
| Primary | Survival Rate With or Without Transplant | 2-year follow-up | The primary outcome is to compare all patients who survive (with or without transplant) to those who die. |
| Secondary | To Compare Patients Who Survive Without Transplantation to All Other Patients Enrolled in This Study (Those Who Receive a Transplant and Live, Those Who Receive a Transplant and Die, or Those Who Die Before Transplantation). | 3 Week follow-up | The estimated minimum enrollment for any statistical validity was 100 patients. Due to low enrollment (8 participants) and the likelihood of generating any meaningful study data moving forward, the DSMB recommended the early termination of the study. Data was not collected since study was terminated, therefore no data to analyze. |
| Secondary | To Compare Patients Who Survive Without Transplantation to All Other Patients Enrolled in This Study (Those Who Receive a Transplant and Live, Those Who Receive a Transplant and Die, or Those Who Die Before Transplantation). | 1-year follow-up | The estimated minimum enrollment for any statistical validity was 100 patients. Due to low enrollment (8 participants) and the likelihood of generating any meaningful study data moving forward, the DSMB recommended the early termination of the study. Data was not collected since study was terminated. |
| Secondary | To Compare Patients Who Survive Without Transplantation to All Other Patients Enrolled in This Study (Those Who Receive a Transplant and Live, Those Who Receive a Transplant and Die, or Those Who Die Before Transplantation). | 2-year follow-up | The estimated minimum enrollment for any statistical validity was 100 patients. Due to low enrollment (8 participants) and the likelihood of generating any meaningful study data moving forward, the DSMB recommended the early termination of the study. Data was not collected since study was terminated. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Survival Rate With or Without Transplant | 3 Weeks | The estimated minimum enrollment for any statistical validity was 100 patients. Due to low enrollment (8 participants) and the likelihood of generating any meaningful study data moving forward, the DSMB recommended the early termination of the study. Data was not collected since study was terminated, therefore there was no data to analyze. | ||
| PRIMARY | Survival Rate With or Without Transplant | 1-year follow-up | The estimated minimum enrollment for any statistical validity was 100 patients. Due to low enrollment (8 participants) and the likelihood of generating any meaningful study data moving forward, the DSMB recommended the early termination of the study. Data was not collected since study was terminated. | ||
| PRIMARY | Survival Rate With or Without Transplant | 2-year follow-up | The estimated minimum enrollment for any statistical validity was 100 patients. Due to low enrollment (8 participants) and the likelihood of generating any meaningful study data moving forward, the DSMB recommended the early termination of the study. Data was not collected since study was terminated. | ||
| SECONDARY | To Compare Patients Who Survive Without Transplantation to All Other Patients Enrolled in This Study (Those Who Receive a Transplant and Live, Those Who Receive a Transplant and Die, or Those Who Die Before Transplantation). | 3 Week follow-up | Data was not collected since study was terminated, therefore there was no data to analyze. | ||
| SECONDARY | To Compare Patients Who Survive Without Transplantation to All Other Patients Enrolled in This Study (Those Who Receive a Transplant and Live, Those Who Receive a Transplant and Die, or Those Who Die Before Transplantation). | 1-year follow-up | Data was not collected since study was terminated, therefore there was no data to analyze. | ||
| SECONDARY | To Compare Patients Who Survive Without Transplantation to All Other Patients Enrolled in This Study (Those Who Receive a Transplant and Live, Those Who Receive a Transplant and Die, or Those Who Die Before Transplantation). | 2-year follow-up | Data was not collected since study was terminated, therefore there was no data to analyze. |
Source ClinicalTrials.gov
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | N-acetycylcysteine | 8 | |
| Overall Study | COMPLETED | N-acetycylcysteine | 8 | |
| Overall Study | NOT COMPLETED | N-acetycylcysteine | 0 |
Source ClinicalTrials.gov
Adverse events1
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 | Pruritus | Skin and subcutaneous tissue disorders | N-acetycylcysteine | 1 | 8 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | N-acetycylcysteine | ||
| Total, other adverse events | N-acetycylcysteine | 1 | 8 |
| Total, serious adverse events | N-acetycylcysteine | 0 | 8 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37183883 | DERIVED |
Source PubMed
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/NCT00896025
GET https://conductscience.org/api/trials/v1/NCT00896025/registered