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This trial is complete. It is no longer accepting participants. Results may be available on ClinicalTrials.gov.

NCT00004467

NCT00004467
Completed Phase 3

Who may be able to join

Who might be able to join this trial:

  • You are between 18 and 70 years old
  • You have been diagnosed with sudden (acute) liver failure, meaning your liver stopped working properly within the last 26 weeks and you have no history of long-term liver disease
  • Your liver failure has caused changes in your mental awareness (such as confusion) and problems with blood clotting
  • You are being treated in a hospital intensive care unit (ICU) and can start the study treatment within the first 24 hours of being admitted
  • If you were already in the hospital for another reason and then developed confusion as a new symptom, you may also qualify
  • If you were transferred from another hospital, you may still be eligible as long as no other specific treatment plan has been started and no special liver support machine has been used

Who may not be able to join:

  • You are under 18 or over 70 years old
  • Your liver failure is thought to be caused by a Tylenol (acetaminophen) overdose or mushroom poisoning
  • Your liver failure was caused by a sudden loss of blood flow to the liver (sometimes called "shock liver"), though heat stroke is not automatically excluded
  • You are pregnant, or your liver failure is related to pregnancy complications
  • Your liver failure is thought to be caused by cancer spreading within the liver
  • You are showing signs of severe brain swelling at the time of enrollment
  • Your blood pressure is dangerously low (systolic at or below 70 mmHg) or you need medications to keep your blood pressure up at the time of enrollment
  • You have a severe infection, including a very high fever (above 39°C / 102.2°F) or significant bacteria in the bloodstream at the time of enrollment

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Trial details

Status
Completed
Phase
Phase 3
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Registry
clinicaltrials_gov
Start date
1 June 1998
Est. completion
1 November 2006

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Overall survival rate

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

View original record on ClinicalTrials.gov