Actively Recruiting
An Exploratory Study to Evaluate the Efficacy and Safety of TYNADOTE4 Combined N-acetylcysteine in the Treatment of Acetaminophen Overdose
Led by Sinew Pharma Inc. · Updated on 2024-01-10
24
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
S
Sinew Pharma Inc.
Lead Sponsor
T
Taipei Veterans General Hospital, Taiwan
Collaborating Sponsor
AI-Summary
What this Trial Is About
The trial investigates the efficacy and safety of TYNADOTE4 combined with intravenous N-acetylcysteine (NAC) for treating acetaminophen overdose. The study focuses on patients poisoned by acetaminophen who meet specific ingestion or plasma concentration criteria. This Phase 2 study aims to assess liver function and injury markers to understand TYNADOTE4's potential impact when added to standard NAC therapy. Participants will be randomly assigned in a 1:1 ratio to receive either oral TYNADOTE4 or a matching placebo alongside the standard NAC intravenous regimen. The NAC treatment includes a loading dose followed by two maintenance infusions over 20 hours. TYNADOTE4 or placebo is given with a 400 mg loading dose followed by 17 doses of 200 mg every 4 hours from Day 1 to Day 3. During the 21-day study, participants will have frequent vital sign checks and blood tests to monitor liver enzymes, bilirubin, coagulation, and drug concentrations at multiple time points before and after dosing. Safety assessments, adverse event reviews, physical exams, and follow-ups occur through Day 21. The primary outcome is alanine aminotransferase (ALT) levels at Day 3, with several secondary outcomes covering liver function, hepatic failure, mortality, and drug metabolite levels.
CONDITIONS
Brief Title
To Evaluate the Efficacy and Safety of TYNADOTE® in the Treatment of Acetaminophen Overdose
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Poisoning and hospitalized patients taking acetaminophen.
- Acute ingestion of more than 150 mg/kg or plasma concentration of acetaminophen above the treatment line on single acute acetaminophen overdose nomogram.
- Male or female aged more than 20 years at screening.
- Ability and willingness to provide informed consent, adhere to the study visit schedule, and complete all study assessments.
You will not qualify if you...
- Sequential Organ Failure Assessment (SOFA) Score higher than 12.
- Fulfillment of King's College Hospital (KCH) Criteria for liver transplantation.
- Conscious disturbance.
- History of allergic responses to N-acetylcysteine (NAC), mannitol, sucralose, or related drugs.
- Unable to take medicine by oral route.
- Receiving any investigational drug within 30 days prior to first dosing.
- Asthma or bronchitis attack with medication therapy within six months prior to enrollment.
- Donated more than 150 mL of blood within two months prior to first dosing or donated plasma within 14 days prior.
- 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 other conditions interfering with study evaluation.
- Poisoning contains acetaminophen combined with other compounds.
- Body weight less than 50 kg.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 days
Participants receive oral TYNADOTE® or placebo combined with intravenous N-acetylcysteine (NAC) to treat acetaminophen overdose. Vital signs and blood samples are collected frequently during this period to monitor liver function and drug levels.
Multiple visits and assessments during Day 1 to Day 3 including frequent vital sign checks and blood draws
Duration - Up to 18 days
Participants return to the clinic for follow-up visits to assess liver function and review any adverse events after treatment completion.
2 visits (Day 7 and Day 21)
Trial Site Locations
Total: 1 location
1
Taipei Veterans General Hospital
Taipei, Beitou District, Taiwan, 11217
Actively Recruiting
Research Team
C
ChengHuei Mr. Hsiong, Vice President
W
WanLing Ms. Yang, Research
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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