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Tests treatment safety and results for Hepatitis
Official title To Evaluate the Efficacy and Safety of TYNADOTE® in the Treatment of Acetaminophen Overdose
ClinicalTrials.gov ID: NCT05557448
What this study is testing
What is TYNADOTE?
TYNADOTE is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for hepatitis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To evaluate the efficacy and safety of TYNADOTE® in the treatment of acetaminophen overdose
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 and older
You may be able to join if
- 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...
- 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.
You likely can't join if
- people with Sequential Organ Failure Assessment (SOFA) Score higher than 12.
- people who fulfilled the King's College Hospital (KCH) Criteria for liver transplantation.
- people 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.
See the full eligibility criteria
- 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.
- people with Sequential Organ Failure Assessment (SOFA) Score higher than 12.
- people who fulfilled the King's College Hospital (KCH) Criteria for liver transplantation.
- people 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 people will be advised not to donate blood for four weeks...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Taipei, Beitou District, Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 20 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Taipei, Beitou District, Taiwan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.