RecruitingPhase 2NCT05557448

To Evaluate the Efficacy and Safety of TYNADOTE® in the Treatment of Acetaminophen Overdose

An Exploratory Study to Evaluate the Efficacy and Safety of TYNADOTE® Combined N-acetylcysteine in the Treatment of Acetaminophen Overdose

Sponsor

Sinew Pharma Inc.

Enrollment

24 participants

Start Date

May 1, 2023

Study Type

INTERVENTIONAL

Conditions

To evaluate the efficacy and safety of TYNADOTE® in the treatment of acetaminophen overdose

Min Age: 20 Years

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.

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.

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DRUGTYNADOTE

Subjects will take 200 mg/every 4 hours, with a loading dose (400 mg) and then followed by 17 maintenance doses

DRUGPlacebo Oral Tablet

Subjects will take 200 mg/every 4 hours, with a loading dose (400 mg) and then followed by 17 maintenance doses

Taipei Veterans General Hospital

Taipei, Beitou District, Taiwan

View Full Details on ClinicalTrials.gov

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NCT05557448