Evaluating TYNADOTE® for treating acetaminophen overdose

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to assess the efficacy and safety of TYNADOTE® in patients who have experienced an acetaminophen overdose. The study will involve a 21-day treatment period where eligible participants will be randomized to receive either TYNADOTE® or a placebo alongside standard intravenous N-acetylcysteine (NAC) therapy. Participants will undergo various assessments, including vital sign monitoring and blood tests to evaluate liver function and drug concentration levels. The goal is to determine if TYNADOTE® can improve outcomes in patients suffering from acute liver failure due to acetaminophen toxicity.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Poisoning and hospitalized patients taking acetaminophen.
* Acute ingestion of more than 150 mg/kg or plasma concentration of Acetaminophen is above the treatment line on single acute acetaminophen overdose nomogram.
* Male or female with age more than 20 years at Screening.
* Ability and willingness to provide informed consent, adhere to the study visit schedule and complete all study assessments.

Exclusion Criteria:

* Subjects with Sequential Organ Failure Assessment (SOFA) Score higher than 12.
* Subjects who fulfilled the King's College Hospital (KCH) Criteria for liver transplantation.
* Subjects who was conscious disturbance.
* History of allergic response(s) to N-acetylcysteine (NAC), mannitol, sucralose or related drugs.
* Subject who was unable to take medicine by oral route.
* Receiving any investigational drug within 30 days prior to first dosing.
* Subject who had attacked asthma or bronchitis combined with medication therapy within six months prior to enrollment.
* Donating greater than 150 mL of blood within two months prior to first dosing or donating plasma (e.g. plasmapheresis) within 14 days prior to first dosing. All subjects will be advised not to donate blood for four weeks after completing the study.
* Subject is pregnant or breastfeeding. Women of childbearing potential must have a negative serum pregnancy test at baseline.
* Anuria, pulmonary congestion, severe congestive heart failure, brain hemorrhage, or any conditions that in the opinion of the investigator may interfere with the evaluation of study objectives.
* The combination of poisoning contains acetaminophen and other compound.
* Body weight less than 50 kg.

Where it's running

• Taipei Veterans General Hospital
  Taipei, Beitou District, Taiwan Recruiting

Study contacts

• Study coordinator: ChengHuei Mr. Hsiong, Vice President
• Email: info@sinewpharma.com
• Phone: +886-2-2788-5365

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.