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Maralixibat Chloride

Maralixibat Chloride is an investigational drug currently being studied in clinical trials for its potential to treat cholestatic pruritus, a condition characterized by severe itching associated with liver diseases. This article explores the ongoing research into this medication, its potential benefits, and what patients should know about participating in these trials.

Table of Contents

What is Maralixibat Chloride?

Maralixibat Chloride is a medication currently being studied for the treatment of cholestatic pruritus, which is severe itching associated with certain liver conditions. It is taken as an oral solution, meaning it’s a liquid medicine that you drink.[1]

What is Cholestatic Pruritus?

Cholestatic pruritus is a persistent and often severe itching that occurs in people with certain liver diseases. It happens when the flow of bile (a digestive fluid produced by the liver) is reduced or blocked, leading to a buildup of substances in the blood that can cause intense itching.[1]

How Does Maralixibat Work?

Maralixibat Chloride is what’s known as an ileal bile acid transporter (IBAT) inhibitor. This means it works by blocking a specific transporter in the intestines that normally helps to recycle bile acids back into the body. By doing this, Maralixibat helps to reduce the levels of bile acids in the blood, which may help to relieve the itching associated with cholestatic liver diseases.[1]

Current Clinical Trial

A clinical trial is currently underway to test how well Maralixibat works for treating cholestatic pruritus. This is a Phase 3 study, which means it’s in an advanced stage of testing. The study is:

  • Randomized: Participants are randomly assigned to either receive Maralixibat or a placebo (a substance with no active ingredients).
  • Double-blind: Neither the participants nor the researchers know who is receiving the real medication and who is receiving the placebo.
  • Placebo-controlled: Some participants receive a placebo to compare the effects with those who receive the actual medication.
This design helps ensure that the results of the study are as accurate and unbiased as possible.[1]

Who Can Participate in the Study?

The study is looking for participants who:

  • Are at least 6 months old
  • Have been diagnosed with a cholestatic liver disease that causes itching
  • Have had itching for more than 90 days
  • Have higher than normal levels of bile acids in their blood
There are also some reasons why a person might not be able to participate, such as having certain other medical conditions or taking certain medications.[1]

What to Expect During the Study

If you participate in the study:

  • You’ll need to take the study medication (or placebo) daily for 40 weeks.
  • You’ll be asked to keep track of your itching using a special tool called the ItchRO (Itch Reported Outcome).
  • You’ll have regular check-ups and blood tests to monitor your health and the effects of the medication.
  • The researchers will be looking at how much your itching improves and how the medication affects the levels of bile acids in your blood.
[1]

Potential Benefits of Maralixibat

While the study is still ongoing and we don’t know the final results yet, the researchers hope that Maralixibat will:

  • Reduce the severity of itching in people with cholestatic liver diseases
  • Lower the levels of bile acids in the blood
  • Improve quality of life for people suffering from chronic itching due to liver disease
It’s important to remember that these potential benefits are still being studied, and not all participants may experience them.[1]

Aspect Details
Drug Name Maralixibat Chloride
Drug Type Ileal bile acid transporter (IBAT) inhibitor
Condition Studied Cholestatic Pruritus
Main Objective Evaluate efficacy in reducing pruritus severity
Study Design Randomized, Double-Blind, Placebo-Controlled Phase 3 Study
Primary Endpoint Change in ItchRO(Obs) severity score from baseline through Weeks 13-20
Key Secondary Endpoints Change in total serum bile acid levels, percentage of days with pruritus improvement
Participant Age ≥6 months
Treatment Duration Up to 40 weeks
Dosage Form Oral Solution

FAQ

  • What is Maralixibat Chloride? Maralixibat Chloride is an ileal bile acid transporter (IBAT) inhibitor being studied as a potential treatment for cholestatic pruritus, which is severe itching related to liver diseases.
  • What is the main goal of the clinical trial for Maralixibat Chloride? The main goal is to evaluate how effective Maralixibat is compared to a placebo in reducing the severity of itching (pruritus) in patients with cholestatic liver diseases.
  • Who can participate in this clinical trial? Participants must be at least 6 months old, have a diagnosis of cholestatic liver disease with persistent itching, and meet specific criteria regarding liver function and pruritus severity. Some liver conditions, like Alagille syndrome and primary biliary cholangitis, are excluded.
  • How is the effectiveness of Maralixibat measured in the trial? The primary measure is the change in itch severity, assessed using a special scale called the Observer-rated Itch-Reported Outcome (ItchRO[Obs]). The trial also looks at changes in bile acid levels and other related factors.
  • How long does the clinical trial last? The trial lasts up to 40 weeks, with the main evaluation period occurring between weeks 13 and 20 of treatment.

Ongoing Clinical Trials on Maralixibat Chloride

  • Study on Maralixibat Chloride for Treating Itchy Skin in Patients with Cholestatic Pruritus

    Not recruiting

    1 1
    Investigated drugs:
    France Germany Italy Poland Spain

Glossary

  • Cholestatic Pruritus: Severe itching associated with liver diseases that affect the flow of bile.
  • Ileal Bile Acid Transporter (IBAT) Inhibitor: A type of medication that blocks the absorption of bile acids in the intestine, potentially helping to reduce itching in liver diseases.
  • Placebo: A substance with no active medical effects, used as a control in testing new drugs.
  • ItchRO(Obs): Observer-rated Itch-Reported Outcome, a scale used to measure the severity of itching in clinical trials.
  • Serum Bile Acid (sBA): The level of bile acids in the blood, which can be elevated in certain liver conditions.
  • Randomized Double-Blind Study: A type of clinical trial where participants are randomly assigned to different treatment groups, and neither the participants nor the researchers know who is receiving the actual drug or placebo.
  • Inclusion Criteria: Specific characteristics that people must have to be able to participate in a clinical trial.
  • Exclusion Criteria: Specific characteristics that prevent people from participating in a clinical trial.
  • Baseline: The initial measurement taken before treatment begins, used as a comparison point for later measurements.

References

  1. http://clinicaltrials.eu/trial/study-on-maralixibat-chloride-for-treating-itchy-skin-in-patients-with-cholestatic-pruritus/