Investigation of VMX-C001 for Coagulation Restoration in Patients on DOACs Experiencing Bleeding or Requiring Anticoagulation Reversal Prior to Urgent Surgery

The primary objective of the study is to evaluate the efficacy of **VMX-C001** in restoring coagulation in patients taking direct oral anticoagulants (DOACs) who are experiencing bleeding or require reversal of anticoagulation prior to urgent surgery. This is clinically relevant as it addresses the critical need for effective management of bleeding complications or the necessity for rapid anticoagulation reversal in emergency surgical situations.

The clinical trial involves a study population comprising both **male** and **female** participants, with an age range categorized as adults. The trial does not include a vulnerable population. The study focuses on individuals who require the restoration of coagulation due to bleeding or the need for reversal of anticoagulation prior to urgent surgery, specifically in patients taking direct oral anticoagulants (DOACs). The sponsor has not provided information regarding the total number of participants or specific lifestyle considerations such as diet, physical activity, or habits. The selection criteria for the trial population have not been disclosed, and no key inclusion or exclusion criteria have been highlighted. The sponsor has not given information on the total number of participants.

The clinical trial is designed to evaluate the efficacy of **VMX-C001** in restoring coagulation in patients taking direct oral anticoagulants (DOACs) who are experiencing bleeding or require reversal of anticoagulation prior to urgent surgery. This study is a Phase 3, randomized, double-blind, controlled trial. The estimated recruitment start date is December 15, 2022, with an anticipated end date of December 31, 2029. The trial will involve multiple study visits, beginning with an inclusion visit to screen participants for eligibility based on specific criteria. Following successful screening, participants will be randomly assigned to either the treatment group receiving VMX-C001 or a control group. The trial will include several follow-up visits to monitor the participants' response to the treatment and to assess any adverse events. The end-of-study visit will conclude the trial, where final assessments will be conducted to evaluate the primary and secondary endpoints. The expected length of participant involvement will vary depending on individual response and adherence to the study protocol. Conditions that may lead to early termination from the study include significant adverse reactions, non-compliance with study procedures, or withdrawal of consent by the participant. The trial aims to provide comprehensive data on the safety and efficacy of VMX-C001 in the specified patient population.

In this clinical trial, the experimental medication and non-experimental treatments have not been specified in the provided data. Therefore, a detailed description of the experimental medication, including its name, pharmaceutical form, dosage, route, and frequency of administration, cannot be provided. Similarly, information regarding any non-experimental treatments such as standard-of-care therapy, placebo, or comparator treatment is not available.

Due to the absence of specific details, additional relevant information about drug administration, dosing schedules, and participant compliance monitoring cannot be included. The data does not contain any information about the pharmaceutical form, maximum daily dose, maximum total dose, or maximum treatment period of the experimental medication. Furthermore, there is no information regarding whether the product is a **paediatric formulation** or an **orphan drug**. The trial details, including the full title and main objective, are also not provided.

The clinical trial is designed to assess efficacy in a Phase 3 study. The trial is scheduled to commence recruitment on December 15, 2022, with an estimated completion date of December 31, 2029. The efficacy assessment will be conducted through a series of predefined parameters, although specific endpoints and methods for measuring efficacy are not detailed in the available data. The trial will follow a structured protocol to ensure the collection and analysis of efficacy data, adhering to the standards expected in a Phase 3 clinical trial. The study will be conducted over a significant period, allowing for comprehensive evaluation of the treatment's efficacy.