Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • TYNADOTE

    Drug

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

  • Placebo Oral Tablet

    Drug

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

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: Test drugActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Alanine aminotransferase

Percentage change from baseline of ALT at Day 3.

Time frame
Day 3

Secondary outcomes

1

Alanine aminotransferase

Percentage change from baseline of ALT at Day 7

Time frame
Day 7
2

Alanine aminotransferase

Percentage change from baseline of AST at Day 3, Day 7

Time frame
Day 7
3

Total bilirubin

Incidence of total bilirubin \> 2.5mg/dL at Day 3, Day 7, Day 21

Time frame
Day 3, Day 7 and Day 21
4

Inte- rnational Normalize Ratio

Incidence of INR \> 1.25 at Day 3, Day 7, Day 21

Time frame
Day 3, Day 7 and Day 21

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sinew Pharma Inc.

Lead sponsor

Taipei Veterans General Hospital, Taiwan

Collaborator

Source ClinicalTrials.gov
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