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ACICLOVIR SODIUM

Clinical trials investigating ACICLOVIR SODIUM are studying it as part of a treatment plan in patients with relapsing-remitting multiple sclerosis who have had the disease for less than 10 years. These trials aim to evaluate safety, especially whether treatment-related serious side effects are acceptably low. The study is in Phase 2 and includes adults with this condition.

Table of contents

Trial overview

The HiHat trial is an interventional study of ACICLOVIR SODIUM in people with relapsing-remitting multiple sclerosis.[1] The trial is authorised and is designed as a Phase 2 study.[1]

Who can participate

This study is for patients with relapsing-remitting multiple sclerosis and a disease duration of less than 10 years.[1] In simple terms, this means the trial is focused on people whose multiple sclerosis started relatively recently and follows a pattern of flare-ups and recovery periods.[1]

What is being studied

The main goal is to see whether the serious adverse event rate linked to sequential treatment with rituximab followed by cladribine is acceptably low.[1] A serious adverse event is a harmful medical problem that is important enough to be considered serious, and the study counts events that are at least possibly related to treatment.[1]

ACICLOVIR SODIUM is part of the treatment set used in the study, together with cetirizine, methylprednisolone, rituximab, cladribine, sulfamethoxazole and trimethoprim, and paracetamol.[1]

Study phase and design

This is a Phase 2 interventional trial, which means researchers are actively giving treatments and then measuring what happens in the study group.[1] The trial includes 50 participants.[1]

Endpoints being measured

The primary endpoint is a binary indicator of at least one treatment-related serious adverse event per participant.[1] A binary indicator is a yes-or-no result, so each participant is counted as either having at least one event or not having one.[1]

Trial status and size

The study status is Authorised, which means it has been approved to proceed in the setting described in the trial record.[1] The planned enrollment is 50 people, which makes it a relatively small study focused on early safety information.[1]

Trial ID Phase Condition studied Status Enrollment
2024-519700-28-01 Phase 2 Relapsing-remitting multiple sclerosis with less than 10 years disease duration Authorised 50

FAQ

  • Who can take part in the ACICLOVIR SODIUM trial? The trial is for patients with relapsing-remitting multiple sclerosis and a disease duration of less than 10 years. It is designed for people who match these study criteria.
  • What is the trial trying to find out? The main goal is to see whether the rate of treatment-related serious adverse events is acceptably low. A serious adverse event is a harmful medical event that is important enough to be called serious.
  • What phase is the study? This is a Phase 2 trial. Phase 2 studies usually look more closely at safety and early signs that a treatment plan may be suitable for further testing.
  • What condition is being studied? The trial is studying relapsing-remitting multiple sclerosis. This is a type of multiple sclerosis where symptoms come and go in attacks, with periods of recovery in between.
  • What treatments are included in the study? The study includes ACICLOVIR SODIUM along with several other treatments: cetirizine, methylprednisolone, rituximab, cladribine, sulfamethoxazole and trimethoprim, and paracetamol. The trial is looking at the overall treatment sequence and safety.

Igangværende kliniske forsøg for ACICLOVIR SODIUM

  • Undersøgelse af rituximab efterfulgt af cladribin til patienter med attakvis tilbagevendende multipel sklerose med sygdomsvarighed under 10 år

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Ordliste

  • Relapsing-remitting multiple sclerosis: A type of multiple sclerosis where symptoms flare up, then improve or go into remission for a time.
  • Disease duration: How long a person has had the disease since it was first diagnosed or started.
  • Phase 2: A trial stage that looks more closely at safety and early effectiveness in a small group of patients.
  • Interventional study: A study where researchers give one or more treatments and then measure the results.
  • Serious adverse event (SAE): A serious harmful medical event during a study, such as one that is life-threatening, needs hospital care, or causes major harm.
  • Treatment-related: Something that may be caused by the study treatment.
  • Binary indicator: A yes-or-no result, such as whether at least one event happened or not.
  • Sequential treatment: Treatment given in a set order, one step after another.
  • Rituximab: One of the treatments used in the trial sequence.
  • Cladribine: One of the treatments used in the trial sequence.

Referencer

  1. https://clinicaltrials.gov/study/2024-519700-28-01