A Multi-center, Double-blind, Randomized, Controlled Study to Determine the Efficacy and Safety of a New Formulation of Acetylcysteine Injection
Trial Snapshot
- Phase
- Phase 3
- Status
- Terminated
- Sponsor
- Enrollment
- 17
- Locations
- 14
- Primary Endpoint
- The Incidence of Hepatoxicity as Measured by the Percentage of Subjects With an Alanine Transaminase (ALT) or Aspartate Transaminase (AST) Value > 1000 U/L Versus Those With an ALT and AST < 1000 U/L
Study Overview
Brief Summary
The primary purpose of this study is determine if a new formulation of Acetadote is at least as effective as the current formulation in the prevention and treatment of acetaminophen overdose related liver injury.
Detailed Description
The primary objective of this study is to demonstrate non-inferiority of efficacy determined by the proportion of subjects who develop hepatotoxicity when treated with a new formulation of Acetadote and the proposed new dosing regimen compared to the rate of hepatotoxicity with the current formulation of Acetadote and the current dosing regimen.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 12 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Any subject requiring treatment with acetylcysteine for acute acetaminophen toxicity
Exclusion Criteria
- •History of allergy or hypersensitivity to acetylcysteine or any component of Acetadote.
- •Exposed to investigational drugs within 30 days before Clinical Trial Material (CTM) administration.
- •Pregnant or nursing.
- •Less than 12 years of age.
- •Have a baseline alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >1000 U/L.
- •Have a baseline International Normalized. Ratio (INR) > 2.0
- •Be on dialysis or having existing renal injury such that the volume of the study drug administration would render the patient unsuitable for the study, in the opinion of the investigator.
- •Have congestive heart failure such that the volume of the study drug administration would render the patient unsuitable for the study, in the opinion of the investigator.
- •Inability to understand the requirements of the study. Subjects must be willing to provide written informed consent or consent of parent/legal guardian (as evidenced by signature on an informed consent document approved by an Institutional Review Board [IRB]), and agree to abide by the study restrictions. (If the subject is incapacitated, informed consent will be sought from a legally acceptable representative).
- •Refusal to provide written authorization for use and disclosure of protected health information.
- •Be otherwise unsuitable for the study, in the opinion of the Investigator.
Arms & Interventions
Acetadote without EDTA
Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free]
Intervention: Acetadote EF (Ethylenediaminetetraacetic Acid (EDTA) - Free) (Drug)
Acetadote
Acetadote [Old formulation containing EDTA]
Intervention: Acetadote (Drug)
Outcomes
Primary Outcomes
The Incidence of Hepatoxicity as Measured by the Percentage of Subjects With an Alanine Transaminase (ALT) or Aspartate Transaminase (AST) Value > 1000 U/L Versus Those With an ALT and AST < 1000 U/L
Time Frame: 21 hours
Because the study was terminated prematurely due to lack of enrollment, there was an insufficient sample size to conduct an efficacy analysis.
Secondary Outcomes
- To Evaluate the Percentage of Subjects Requiring Continued Therapy(21 hours)
- To Evaluate the Incidence of Clinical Need for Therapy Beyond the Current 21 Hour FDA Approved Dosing Regimen.(42 hours)
- To Evaluate the Incidence of Treatment Emergent Adverse Events(21-42 hours)
- To Evaluate the Incidence of Anaphylactoid Reaction.(1 hour)