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Sebetralstat

Clinical trials are investigating Sebetralstat in people with hereditary angioedema, a condition that causes swelling attacks. These studies look at safety, tolerability, and how well the treatment works over time in adults, adolescents, and children with type I or II disease.

Table of contents

Trial overview

The clinical trials provided are studying Sebetralstat in people with hereditary angioedema type I or II.[1][2]

Both studies are interventional trials, which means patients receive the study treatment so researchers can observe the results.[1][2]

The main goal of these trials is to learn about safety, tolerability, and how well the treatment may work in different age groups.[1][2]

Who can participate

One study includes adolescent and adult patients with hereditary angioedema type I or II.[1]

The other study includes pediatric patients aged 2 to less than 12 years with hereditary angioedema type I or II.[2]

This means the trials are looking at both older patients and younger children, but they are still focused on the same condition.[1][2]

Trial phases and status

Both trials are Phase 3 studies, which are later-stage clinical trials that usually involve more patients than early studies.[1][2]

NCT05505916 is listed as authorised and plans to include 150 patients.[1]

NCT06467084 is listed as completed and included 48 patients.[2]

What the trials measure

The long-term study measures the number and percentage of patients with adverse events, serious adverse events, and adverse events that caused treatment to stop early.[1]

It also measures laboratory results and vital signs at scheduled visits to check patient safety over time.[1]

The pediatric study measures the proportion of children who have any adverse event during the study, including fatal adverse events if they occur.[2]

In simple terms, these outcomes help researchers see whether the treatment is safe and how children and adults respond during the study.[1][2]

Key trial details

NCT05505916 is a long-term study designed to evaluate whether Sebetralstat is safe and effective for treating attacks in patients with hereditary angioedema.[1]

The brief summary says the study is assessing the safety of long-term administration in adolescent and adult patients with HAE type I or II.[1]

The trial uses oral study drug doses listed as 900 mg and 1200 mg.[1]

NCT06467084, called KONFIDENT-KID, is a pediatric Phase 3 study focused on safety and tolerability in children aged 2 to less than 12 years.[2]

The trial uses oral study drug doses listed as 450 mg and 900 mg.[2]

What these studies mean for patients

These trials are important because they test Sebetralstat in different age groups with hereditary angioedema type I or II.[1][2]

They focus on safety data such as side effects, lab tests, and vital signs, which helps researchers understand how the treatment performs in real study settings.[1]

The pediatric study adds information for younger children, while the long-term study adds information for adolescents and adults.[1][2]

Based on the trial data provided, the research program is centered on hereditary angioedema and does not list other diseases.[1][2]

Trial ID Phase Condition studied Status Enrollment
NCT05505916 Phase 3 Hereditary Angioedema Type I or II Authorised 150
NCT06467084 Phase 3 Hereditary Angioedema Type I or II Completed 48

FAQ

  • What is being studied in Sebetralstat clinical trials? The trials are studying Sebetralstat in people with hereditary angioedema type I or II. They focus on safety, tolerability, and whether the treatment can help manage swelling attacks over time.
  • Who can take part in these trials? One study includes adolescent and adult patients with hereditary angioedema type I or II. Another study includes pediatric patients aged 2 to less than 12 years with the same condition.
  • What phases are the Sebetralstat trials? Both trials are Phase 3 studies. Phase 3 means the treatment is being tested in larger groups of patients to learn more about safety and effectiveness.
  • What do the trials measure? The trials measure side effects, serious side effects, reasons for stopping treatment, and changes in lab tests and vital signs. The pediatric study also looks at how many children have any adverse events during the study.
  • Are these trials only for hereditary angioedema? Yes. The trial data provided only includes hereditary angioedema type I or II. No other conditions are listed.

Ongoing Clinical Trials on Sebetralstat

  • Study on the Safety and Effects of Sebetralstat for Children Aged 2-11 with Hereditary Angioedema Type I or II

    Not recruiting

    1 1 1
    Investigated drugs:
    France Germany Italy

  • Long-term Safety Study of KVD900 for Treating Angioedema Attacks in Adolescents and Adults with Hereditary Angioedema Type I or II

    Not recruiting

    1 1 1
    Investigated drugs:
    Austria Bulgaria France Germany Greece Hungary +7

Glossary

  • Hereditary angioedema (HAE): A rare inherited condition that causes repeated swelling attacks. The swelling can affect different parts of the body and may happen suddenly.
  • Type I or II: Two forms of hereditary angioedema. The trials only include patients with these types.
  • Phase 3: A later stage of clinical testing. These studies usually include more patients and help researchers learn about safety and how well a treatment works.
  • Interventional study: A study in which patients receive a treatment so researchers can observe its effects.
  • Enrollment: The number of people planned or included in a study.
  • Adverse event (AE): Any unwanted medical problem that happens during a study, whether or not it is caused by the treatment.
  • Serious adverse event: A more severe unwanted medical problem, such as one that is life-threatening, requires hospital care, or causes major harm.
  • Laboratory results: Test results from blood or other samples that help researchers check a patient's health during the study.
  • Vital signs: Basic body measurements such as blood pressure, pulse, and temperature.
  • Tolerability: How well patients can handle a treatment without major problems.

References