To Evaluate the Efficacy and Safety of TYNADOTE® in the Treatment of Acetaminophen Overdose
ConditionHepatitis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age20+
SponsorSinew Pharma Inc.
About this trial
To evaluate the efficacy and safety of TYNADOTE® in the treatment of acetaminophen overdose
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- TYNADOTE
- Placebo Oral Tablet
Treatment groups
24 Participants
are divided into 2 treatment groupsSponsors and collaborators
Sinew Pharma Inc.
Lead sponsor
Taipei Veterans General Hospital, Taiwan
Collaborator
Source ClinicalTrials.gov