NCT05557448

Brief Summary

To evaluate the efficacy and safety of TYNADOTE® in the treatment of acetaminophen overdose

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_2

Timeline
7mo left

Started May 2023

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress84%
May 2023Dec 2026

First Submitted

Initial submission to the registry

September 22, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 28, 2022

Completed
7 months until next milestone

Study Start

First participant enrolled

May 1, 2023

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

January 10, 2024

Status Verified

January 1, 2024

Enrollment Period

3.6 years

First QC Date

September 22, 2022

Last Update Submit

January 9, 2024

Conditions

Hepatitis

Keywords

ParacetamolAcetaminophenAcute liver failureN-acetylcysteineAcetaminophen overdose

Outcome Measures

Primary Outcomes (1)

  • Alanine aminotransferase

    Percentage change from baseline of ALT at Day 3.

    Day 3

Secondary Outcomes (9)

  • Alanine aminotransferase

    Day 7

  • Alanine aminotransferase

    Day 7

  • Total bilirubin

    Day 3, Day 7 and Day 21

  • Inte- rnational Normalize Ratio

    Day 3, Day 7 and Day 21

  • Aspartate aminotransferase or Alanine aminotransferase

    Day 3, Day 7 and Day 21

  • +4 more secondary outcomes

Study Arms (2)

Test drug

ACTIVE COMPARATOR

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

Drug: TYNADOTE

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo Oral Tablet

Interventions

TYNADOTEDRUG

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

Test drug
Placebo Oral TabletDRUG

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

Placebo

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify 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 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.

You may not qualify if:

  • 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.
  • 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 subjects will be advised not to donate blood for four weeks after completing the study.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Veterans General Hospital

Taipei, Beitou District, 11217, Taiwan

RECRUITING

MeSH Terms

Conditions

HepatitisLiver Failure, Acute

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesLiver FailureHepatic Insufficiency

Central Study Contacts

ChengHuei Mr. Hsiong, Vice President

CONTACT

+886-2-2788-5365info@sinewpharma.com

WanLing Ms. Yang, Research

CONTACT

+886-2-2788-5365wlyang@sinewpharma.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
placebo
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: test drug
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2022

First Posted

September 28, 2022

Study Start

May 1, 2023

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

January 10, 2024

Record last verified: 2024-01

Locations

TW(1)