ClinicalTrials.gg
RecruitingNCT07765823Updated Aug 19, 2026

Role of N-Acetylcysteine in Non-Acetaminophen-Induced Liver Failure

An interventional study of N Acetyl Cysteine and Standard supportive care in Acute Liver Failure, sponsored by King Edward Medical University. Recruiting at 1 site in Pakistan. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-08-19.

Sponsored by King Edward Medical University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jul 2026; still recruiting 3 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
62
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Acute Liver Failure

Keywords

  • hepatic failure
  • acute liver failure
  • acetylcysteine
  • randomized controlled trial
  • supportive care
03

In context

Liver Failure, Acute

96 studies on the registry are indexed under Liver Failure, Acute; 20 are open to participants now.

This study's planned enrollment of 62 is above the median of 44 across 49 interventional studies indexed under Liver Failure, Acute.

Browse Liver Failure, Acute studies →

Lead sponsor

King Edward Medical University is the lead sponsor of 82 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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//HEV, non-acetaminophen drug-induced liver injury, or idiopathic)
  • No NAC treatment received for current episode prior to enrollment

Exclusion criteria

Exclusion Criteria:

  • 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/ to NAC
  • Pregnant women.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
62 participants (estimated)

Study arms

  • Experimental
    NAC Group

    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

    Drug: N Acetyl Cysteine

  • Active comparator
    Control Group

    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

    Other: Standard supportive care

Interventions

  • 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.

    Also known as: NAC

  • OtherStandard supportive care

    Standard supportive care protocol for acute liver failure (glucose control, antimicrobials, PPIs, fluid/electrolyte management, anti-encephalopathy measures, FFP as needed).

    Also known as: Supportive care protocol for liver failure

06

What researchers measure

Primary outcomes

  1. Survival/Mortality rate

    Proportion of patients alive (survival) vs. deceased (mortality) at day 28.

    Time frame: 28 days after enrollment

Secondary outcomes

  1. Length of hospital stay

    Lenght of Hospital stay from admission to death/discharge.

    Time frame: From admission to discharge or death (up to 28 days)

Other outcomes

  1. Change in Liver Function Tests

    Improvement/Decline in liver function tests from Baseline to day i.e Change in bilirubin, albumin, INR, AST, ALT from baseline to day 4.

    Time frame: 4 days

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided — My Team hasn't yet decided about a formal data-sharing infrastructure.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jul 2026 (actual). Primary completion is estimated for Oct 2026, 2 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 10, 2026
First posted
Aug 14, 2026
StartActual
Jul 16, 2026
Primary completionEst.
Oct 15, 2026
CompletionEst.
Oct 17, 2026
Last update
Aug 19, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 19, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07765823
Lead sponsor
King Edward Medical University
Responsible party
somia iqtadar (Associate Professor, King Edward Medical University) — Principal investigator
First posted
Aug 14, 2026
Start date
Jul 16, 2026
Primary completion
Oct 15, 2026 (estimated)
Completion
Oct 17, 2026 (estimated)
Last update
Aug 19, 2026

Study contacts

Somia Iqtadar, FCPS
Contact
somia.iqtadar@gmail.com
+92 42 99211129 ext. 331
Zaeem Ahmad, MBBS
Contact
zaeem.ahmad344@gmail.com
+92 42 99211129 ext. 331
Somia Iqtadar, FCPS
principal investigator · King Edward Medical University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Acetylcysteine

Start the discussion