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Linerixibat

Clinical trials are investigating Linerixibat in people with cholestatic pruritus linked to primary biliary cholangitis (PBC). These studies mainly look at long-term safety, tolerability, and other trial outcomes in adult participants with cholestasis.

Table of Contents

Trial overview

The trial data provided describe one interventional study, which means participants receive a treatment so researchers can observe what happens.[1] This study is testing Linerixibat in people with cholestatic pruritus in primary biliary cholangitis (PBC), a long-term liver disease linked with itching.[1] The study is listed as Phase 3 and is authorised.[1]

Who can participate

The available trial includes participants with cholestatic pruritus in PBC.[1] In simple words, this means the study is focused on people who have itching caused by cholestasis, which is reduced or blocked bile flow from the liver.[1] The source data do not give more detailed entry rules, so the exact age limits and other requirements are not provided here.[1]

What researchers are measuring

The main outcome is the frequency and severity of adverse events during treatment and follow-up.[1] Adverse events are any unwanted medical problems that happen during a study, whether or not they are caused by the study treatment.[1] This tells researchers about the long-term safety of Linerixibat and how well participants can tolerate it over time.[1]

The brief study summary says the goal is to evaluate the safety and tolerability of long-term Linerixibat treatment in participants with cholestatic pruritus in PBC.[1] Safety means looking for medical problems, and tolerability means how well people can take the treatment without too many difficulties.[1]

Study design and visits

The study is planned as a long-term trial with many follow-up visits.[1] Assessments are listed at Day 1, Week 1, and then at Months 1, 2, 3, 6, 9, 12, 18, 24, 30, 36, 42, and 48, with extra visits if needed.[1] There is also a final follow-up phone call 7 to 14 days after the last dose for people who leave the study early or finish treatment.[1]

The intervention listed is Linerixibat 80 mg taken by mouth.[1] The source data do not provide more details about how the treatment is compared with other study groups, so only the listed intervention can be described here.[1]

Trial status and size

The trial identifier is NCT04124965, and the status is listed as authorised.[1] The planned enrollment is 292 participants, which is the number of people the study aims to include.[1] Because this is a Phase 3 study, it is part of later-stage clinical research with a larger group of participants than early-phase trials.[1]

Only one trial was provided in the source data, so the article focuses on that study.[1] The key research question is whether long-term Linerixibat can be studied safely and with acceptable tolerability in people with cholestatic pruritus in PBC.[1]

Trial ID Phase Condition studied Status Enrollment
NCT04124965 Phase 3 Cholestasis; cholestatic pruritus in PBC Authorised 292

FAQ

  • What is being studied in Linerixibat clinical trials? The trial data focus on long-term safety and tolerability of Linerixibat in people with cholestatic pruritus in PBC. The study also tracks adverse events, which are unwanted medical problems that happen during a study.
  • Who can take part in these trials? The available trial includes participants with cholestatic pruritus in PBC. This means people with itching caused by cholestasis, a condition where bile flow is reduced or blocked.
  • What phase is the Linerixibat trial? The trial listed is a Phase 3 study. Phase 3 trials are larger studies that help researchers learn more about how well a treatment performs and how safe it is over time.
  • What condition is being studied? The trial is studying cholestasis and cholestatic pruritus in primary biliary cholangitis, also called PBC. PBC is a long-term liver disease that can cause itching.
  • How many people are in the study? The listed study plans to enroll 292 participants. That number helps show the size of the trial and how much information researchers hope to collect.

Ongoing Clinical Trials on Linerixibat

  • Study on Long-term Safety of Linerixibat for Treating Itchy Skin in Patients with Primary Biliary Cholangitis

    Not recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Bulgaria Czechia France Germany Greece +3

Glossary

  • Cholestasis: A condition where bile does not flow normally from the liver. It can cause symptoms such as itching.
  • Cholestatic pruritus: Itching caused by cholestasis. Pruritus is the medical word for itching.
  • Primary biliary cholangitis (PBC): A long-term liver disease that affects the bile ducts and can lead to cholestasis and itching.
  • Phase 3: A later stage of clinical research with a larger group of participants. It helps researchers study safety and treatment effects over time.
  • Interventional study: A study where participants receive a treatment so researchers can see what happens.
  • Enrollment: The number of people planned to join a study.
  • Adverse event: Any unwanted medical problem that happens during a study, whether or not it is caused by the study treatment.
  • Tolerability: How well people can take a treatment without too many problems.
  • Long-term safety: Information about whether a treatment remains safe when used for a long time.
  • Follow-up: Extra checks after treatment ends to see how participants are doing.

References