Acute Liver FailureNCT07765823
Role of N-Acetylcysteine in Non-Acetaminophen-Induced Liver Failure
A study testing N Acetyl Cysteine and Standard supportive care in people with Acute Liver Failure, run by King Edward Medical University at 1 site in Pakistan.
Trial summary
This randomized controlled trial evaluates whether oral N-acetylcysteine (NAC), given alongside standard supportive care, improves survival and reduces mortality in patients with non-acetaminophen-induced acute liver failure (ALF), compared to supportive care alone. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Acute Liver Failure
- What is being tested?
- N Acetyl Cysteine and Standard supportive care
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 sitePakistan
- Study dates
- 16 Jul 2026to 17 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female, aged 18-60 years
- Diagnosed with non-acetaminophen- induced acute hepatic failure (per operational definition/EASL criteria)
- Etiology other than acetaminophen overdose (viral hepatitis HAV/HBV/HEV, non-acetaminophen drug-induced liver injury, or idiopathic)
- No NAC treatment received for current episode prior to enrollment
Who cannot join
- History of chronic liver disease or cirrhosis
- Prior severe cardiac, renal, neurological, or infectious disease that could confound outcomes
- Prior liver transplant or current transplant candidacy
- Known allergy/contraindication to NAC
- Pregnant women.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
King Edward Medical University/Mayo Hospital Lahore
Lahore, Punjab Province, 54000
Israr Toor, FCPS, +92 42 99211129 ext. 331, zaeem.ahmad344@gmail.com
zaeem.ahmad344@gmail.com
About this study
This randomized controlled trial evaluates whether oral N-acetylcysteine (NAC), given alongside standard supportive care, improves survival and reduces mortality in patients with non-acetaminophen-induced acute liver failure (ALF), compared to supportive care alone. Secondary objectives are to assess NAC's effect on length of hospital stay and improvement in liver function tests. Sixty-two adult patients (18-60 years) will be randomized 1:1 to NAC or control, with outcomes assessed at 28 days (survival/mortality) and day 4 (liver function tests).
Read the detailed description
Acute liver failure carries high mortality, and in resource-limited settings like Pakistan, liver transplantation is often inaccessible, making pharmacologic adjuncts to supportive care important. Prior studies (Nabi et al. 2017; Mumtaz et al. 2009; Parkas et al. 2016) suggest oral NAC may improve survival and shorten hospital stay in non-acetaminophen ALF, though evidence remains limited. This trial will randomly assign eligible patients via computer-generated randomization to receive oral/NG NAC (140 mg/kg every 4 hours for 16 hours, then every 6-8 hours, continued for 3 days) plus standard supportive care, or standard supportive care alone. Standard care includes glucose monitoring, prophylactic antimicrobials, proton pump inhibitors, fluid/electrolyte management, anti-encephalopathy measures as needed, and fresh frozen plasma for bleeding. Patients will be followed for up to 28 days.
- Conditions
- Acute Liver Failure
- Being tested
- N Acetyl Cysteine, Standard supportive care
- Keywords
- hepatic failure, acute liver failure, acetylcysteine, randomized controlled trial, supportive care
- Medical subject headings
- Liver Failure, Acute, Liver Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N Acetyl CysteineDrug
Also called NAC
Oral or nasogastric N-acetylcysteine administered at 140 mg/kg every 4 hours for the first 16 hours, followed by 140 mg/kg every 6-8 hours, continued for a total duration of 3 days, given in addition to standard supportive care.
Standard supportive careOther
Also called Supportive care protocol for liver failure
Standard supportive care protocol for acute liver failure (glucose control, antimicrobials, PPIs, fluid/electrolyte management, anti-encephalopathy measures, FFP as needed).
| Study group | Role | What they receive |
|---|---|---|
| NAC Group | Experimental | Oral or nasogastric N-acetylcysteine, 140 mg/kg every 4 hours for the first 16 hours, then every 6-8 hours, continued for 3 days, plus standard supportive care.
Intervention: Drug: N-acetylcysteine Receives: Drug: N Acetyl Cysteine |
| Control Group | Active comparator | Standard supportive care protocol for acute liver failure (glucose control, antimicrobials, PPIs, fluid/electrolyte management, antiencephalopathy measures, FFP as needed). Intervention: Other: Standard Supportive Care Receives: Other: Standard supportive care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival/Mortality rate
Proportion of patients alive (survival) vs. deceased (mortality) at day 28.
Measured: 28 days after enrollment
Secondary outcomes (1)
Length of hospital stay
Lenght of Hospital stay from admission to death/discharge.
Measured: From admission to discharge or death (up to 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2026
- Study start16 Jul 2026
- Primary completion15 Oct 2026 (estimated)
- Study completion17 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Liver FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly allocated 1:1 to receive either oral/NG N-acetylcysteine plus standard supportive care, or standard supportive care alone, and followed in parallel for outcome assessment through day 28.
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Edward Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, somia iqtadar, King Edward Medical University
- Investigators
- Somia Iqtadar, FCPS, Principal investigator, King Edward Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07765823
- Sponsor's protocol ID
- 667/RC/KEMU
- Status last verified
- Aug 2026
- First submitted
- 10 Aug 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: My Team hasn't yet decided about a formal data-sharing infrastructure.
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of N-Acetylcysteine in Non-Acetaminophen-Induced Liver Failure
- ClinicalTrials.gov ID
- NCT07765823
- Acronym / sponsor ID
- 667/RC/KEMU
- Conditions
- Acute Liver Failure
- Keywords
- hepatic failure, acute liver failure, acetylcysteine, randomized controlled trial, supportive care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- King Edward Medical UniversityUniversity, hospital or other
- Study start
- 16 Jul 2026 (actual)
- Primary completion
- 15 Oct 2026 (estimated)
- Study completion
- 17 Oct 2026 (estimated)
- First posted
- 14 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized controlled trial evaluates whether oral N-acetylcysteine (NAC), given alongside standard supportive care, improves survival and reduces mortality in patients with non-acetaminophen-induced acute liver failure (ALF), compared to supportive care alone. Secondary objectives are to assess NAC's effect on length of hospital stay and improvement in liver function tests. Sixty-two adult patients (18-60 years) will be randomized 1:1 to NAC or control, with outcomes assessed at 28 days (survival/mortality) and day 4 (liver function tests).
Detailed description
Acute liver failure carries high mortality, and in resource-limited settings like Pakistan, liver transplantation is often inaccessible, making pharmacologic adjuncts to supportive care important. Prior studies (Nabi et al. 2017; Mumtaz et al. 2009; Parkas et al. 2016) suggest oral NAC may improve survival and shorten hospital stay in non-acetaminophen ALF, though evidence remains limited. This trial will randomly assign eligible patients via computer-generated randomization to receive oral/NG NAC (140 mg/kg every 4 hours for 16 hours, then every 6-8 hours, continued for 3 days) plus standard supportive care, or standard supportive care alone. Standard care includes glucose monitoring, prophylactic antimicrobials, proton pump inhibitors, fluid/electrolyte management, anti-encephalopathy measures as needed, and fresh frozen plasma for bleeding. Patients will be followed for up to 28 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly allocated 1:1 to receive either oral/NG N-acetylcysteine plus standard supportive care, or standard supportive care alone, and followed in parallel for outcome assessment through day 28.
| Arm | Type | Receives |
|---|---|---|
| NAC Group | Experimental | Drug: N Acetyl CysteineOral or nasogastric N-acetylcysteine, 140 mg/kg every 4 hours for the first 16 hours, then every 6-8 hours, continued for 3 days, plus standard supportive care. Intervention: Drug: N-acetylcysteine |
| Control Group | Active comparator | Other: Standard supportive careStandard supportive care protocol for acute liver failure (glucose control, antimicrobials, PPIs, fluid/electrolyte management, antiencephalopathy measures, FFP as needed). Intervention: Other: Standard Supportive Care |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male or female, aged 18-60 years
- Diagnosed with non-acetaminophen- induced acute hepatic failure (per operational definition/EASL criteria)
- Etiology other than acetaminophen overdose (viral hepatitis HAV/HBV/HEV, non-acetaminophen drug-induced liver injury, or idiopathic)
- No NAC treatment received for current episode prior to enrollment
Key exclusion criteria (5 listed)
- History of chronic liver disease or cirrhosis
- Prior severe cardiac, renal, neurological, or infectious disease that could confound outcomes
- Prior liver transplant or current transplant candidacy
- Known allergy/contraindication to NAC
- Pregnant women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N Acetyl CysteineAlso: NACOral or nasogastric N-acetylcysteine administered at 140 mg/kg every 4 hours for the first 16 hours, followed by 140 mg/kg every 6-8 hours, continued for a total duration of 3 days, given in addition to standard supportive care. | Drug | NAC Group |
| Standard supportive careAlso: Supportive care protocol for liver failureStandard supportive care protocol for acute liver failure (glucose control, antimicrobials, PPIs, fluid/electrolyte management, anti-encephalopathy measures, FFP as needed). | Other | Control Group |
Primary outcome
Survival/Mortality rate
Time frame: 28 days after enrollment
Proportion of patients alive (survival) vs. deceased (mortality) at day 28.
1 secondary outcome
Length of hospital stay
Time frame: From admission to discharge or death (up to 28 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: Undecided. My Team hasn't yet decided about a formal data-sharing infrastructure.
Related trials for Acute Liver Failure
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
RecruitingObservational study
Establishing a Reference Framework for Outcomes After Machine-Preserved Liver Transplantation in Europe
End-stage Liver Disease (ESLD), Acute Liver Failure
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Evaluation of Fibroscan® Performance in Diagnosing Acute Heart Failure in Patients Presenting to the Emergency Department
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CytOSorb TreatMent Of Critically Ill PatientS Registry
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Somia Iqtadar, FCPS principal investigator
King Edward Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing N Acetyl Cysteine and Standard supportive care in people with Acute Liver Failure, run by King Edward Medical University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Somia Iqtadar, FCPS (+92 42 99211129 ext. 331, somia.iqtadar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival/Mortality rate (time frame: 28 days after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.