Actively Recruiting
To Evaluate the Efficacy and Safety of TYNADOTE® in the Treatment of Acetaminophen Overdose
Led by Sinew Pharma Inc. · Updated on 2024-01-10
24
Participants Needed
1
Research Sites
187 weeks
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
To evaluate the efficacy and safety of TYNADOTE® in the treatment of acetaminophen overdose
CONDITIONS
Official 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...
- Hospitalized patients with acetaminophen poisoning
- Acute ingestion of more than 150 mg/kg of acetaminophen or plasma acetaminophen above the treatment line on the overdose nomogram
- Male or female aged more than 20 years at screening
- Ability and willingness to provide informed consent, follow study visits, and complete all assessments
You will not qualify if you...
- Sequential Organ Failure Assessment (SOFA) Score higher than 12
- Meeting King's College Hospital Criteria for liver transplantation
- Presence of conscious disturbance
- History of allergic reactions to N-acetylcysteine, mannitol, sucralose, or related drugs
- Unable to take medicine orally
- Received any investigational drug within 30 days before first dosing
- History of asthma or bronchitis with medication within six months before enrollment
- Donated more than 150 mL of blood within two months or plasma within 14 days before dosing
- Pregnant or breastfeeding women; women of childbearing potential must have negative pregnancy test at baseline
- Anuria, pulmonary congestion, severe congestive heart failure, brain hemorrhage, or conditions interfering with study evaluation
- Poisoning involving 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
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
CONTACT
W
WanLing Ms. Yang, Research
CONTACT
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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