Evaluation of DFV890 for Safety, Tolerability, and Efficacy in Patients with Myeloid Diseases

The primary objective of this study is to evaluate the **safety**, **tolerability**, and **efficacy** of DFV890 in participants diagnosed with **myeloid diseases**. This is clinically relevant as it aims to determine the potential therapeutic benefits and risks associated with DFV890, which could inform treatment strategies for these conditions. No secondary objectives are provided.

The clinical trial involves a total of **41 participants** diagnosed with **myeloid disease**. The study population includes both male and female subjects, with an age range encompassing both adults and older adults. Participants were selected to include a vulnerable population, although specific inclusion or exclusion criteria have not been provided by the sponsor. The general health status of the participants is not detailed, nor are any lifestyle considerations such as diet, physical activity, or habits. The trial aims to gather data from a diverse group, ensuring representation across different age groups and genders.

The clinical trial is designed to evaluate the **safety**, tolerability, and efficacy of DFV890 in participants diagnosed with **myeloid disease**. This study is structured as a Phase 3, randomized, double-blind, controlled trial. The estimated duration of the trial spans from the recruitment start date on February 28, 2023, to the anticipated end date on July 1, 2025. Participants will be involved in the study for a period that aligns with the trial's overall timeline, subject to individual response and adherence to protocol.

The sequence of study visits begins with an inclusion (screening) visit, where potential participants are assessed for eligibility based on predefined criteria. Following successful screening, participants will be randomized and commence the treatment phase. Throughout the trial, regular follow-up visits will be scheduled to monitor the participants' health status, treatment adherence, and any adverse events. These visits are crucial for collecting data on the primary and secondary endpoints of the study. The trial will conclude with an end-of-study visit, where final assessments are conducted to evaluate the overall outcomes of the intervention.

Participant involvement is expected to last until the end of the trial, unless specific conditions necessitate early termination. Such conditions may include significant adverse reactions, non-compliance with the study protocol, or withdrawal of consent by the participant. The trial's design ensures that all procedures are conducted in accordance with ethical standards and regulatory requirements, maintaining the integrity and scientific validity of the research.

The clinical trial involves the administration of an **experimental medication**. However, specific details regarding the name, pharmaceutical form, dosage, route, and frequency of administration of the experimental medication are not provided in the available data. The trial documentation does not specify whether the medication is a **paediatric formulation** or if it is classified as an **orphan drug**. Additionally, there is no information on the maximum daily dose, total dose, or treatment period for the experimental medication.

In addition to the experimental medication, the trial may include the use of **non-experimental treatments** such as standard-of-care therapy, placebo, or comparator treatment. However, the data does not provide explicit details about these treatments. Information regarding the administration, dosing schedules, and participant compliance monitoring for these non-experimental treatments is also not available.

The clinical trial is in Phase 3 and is scheduled to have an estimated recruitment start date of February 28, 2023, with an estimated end date of July 1, 2025. The trial will assess the efficacy of the intervention, although specific parameters or endpoints for evaluating efficacy are not provided. The methods and schedule for measuring, collecting, and analyzing efficacy parameters are not detailed in the available data. The trial is categorized under trial category 1, with a trial category ID of 64420. Further information regarding the tools or instruments involved in efficacy assessments is not specified.