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

3 1 1

What is this study about?

This clinical trial is focused on studying the long-term safety and tolerability of a medication called linerixibat for treating a condition known as cholestatic pruritus in people with Primary Biliary Cholangitis (PBC). Cholestatic pruritus is a type of itching that occurs when there is a problem with bile flow in the liver, and PBC is a chronic disease that slowly destroys the bile ducts in the liver. The medication being tested, linerixibat, is taken in the form of tablets.

The purpose of the study is to evaluate how safe and tolerable linerixibat is when used over a long period. Participants in the study will take linerixibat orally, and the study will monitor them for any side effects or adverse events. The study will involve regular check-ups at various intervals, such as weekly, monthly, and every few months, to ensure the safety of the participants and to gather data on how the medication affects them over time.

Throughout the study, participants will be assessed for changes in their health, including any improvements or worsening of their symptoms. The study will also look at how the medication affects participants’ quality of life, including aspects like sleep and fatigue. This trial aims to provide valuable information on the long-term use of linerixibat for individuals with PBC who experience cholestatic pruritus.

1 joining the study

Upon joining the study, participants will be required to provide signed informed consent. This consent confirms understanding and agreement to comply with the study’s requirements and restrictions.

2 initial assessment

Participants will undergo an initial assessment to confirm eligibility. This includes reviewing medical history, menstrual history, and recent sexual activity for female participants to ensure no early undetected pregnancy.

A highly sensitive urine pregnancy test will be conducted for women of childbearing potential. If the result is ambiguous, a serum pregnancy test will be required.

3 treatment initiation

Participants will begin treatment with linerixibat, administered orally in the form of tablets. The dosage and frequency will be determined by the study protocol and communicated to participants by the study team.

4 regular assessments

Participants will attend regular assessments to monitor the frequency and severity of adverse events. These assessments will occur on Day 1, Week 1, and then monthly at Months 1, 2, 3, 6, 9, 12, 18, 24, 30, 36, 42, and 48.

Additional visits may be scheduled as needed to ensure participant safety and study integrity.

5 follow-up

After the final dose of the study medication, a follow-up phone call will be conducted between Day 7 and Day 14 to check on the participant’s well-being and any potential late-onset effects.

Who Can Join the Study?

  • Participants must be 18 to 80 years old at the time of signing the consent form.
  • Participants must have a diagnosis of PBC (Primary Biliary Cholangitis) and a history of itching related to this condition, as shown by their participation in a previous linerixibat study.
  • Participants must have completed the main treatment period in a previous linerixibat study.
  • For female participants only:
    • Must not be pregnant or breastfeeding.
    • If able to have children, must use an acceptable method of birth control during the study and for at least 4 weeks after the last dose of the study medication.
    • Must have a negative pregnancy test before starting the study medication.
  • Participants must be able to give signed informed consent, which means they understand the study and agree to follow its rules.

Who Cannot Join the Study?

  • Patients with cholestasis cannot participate. Cholestasis is a condition where bile flow from the liver is reduced or blocked.
  • Patients with pruritus related to PBC (Primary Biliary Cholangitis) are excluded. Pruritus means itching, and PBC is a liver disease.
  • Patients outside the age range of 18 to 65 years are not eligible.
  • Both male and female patients can participate, but certain conditions may exclude them.
  • Patients who are part of a vulnerable population are excluded. This means people who might be at higher risk of harm or exploitation.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Azienda Ospedaliera di Padova Padua Italy
Hippokration Hospital Athens Greece
Institute For Clinical And Experimental Medicine Prague Czechia
Centrum Badan Klinicznych Piotr Napora Lekarze sp.p. Wroclaw Poland
Azienda Sociosanitaria Territoriale Santi Paolo E Carlo Milan Italy
Diagnostic Consultation Center XX-Sofia EOOD Sofia Bulgaria
Azienda Ospedaliero Universitaria Di Modena Modena Italy
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Universitario 12 De Octubre Madrid Spain
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo Italy
RESEARCH SITE s.r.o Plzen Czechia
Intermax Sp. z o.o. Czestochowa Poland
ID Clinic Myslowice Poland
Bodyclinic Sp. z o.o. sp.k. Warsaw Poland
Virgen del Rocío University Hospital Sevilla Spain
Universitaetsklinikum Erlangen AöR Erlangen Germany
Hospital Clinic De Barcelona Barcelona Spain
Universitair Ziekenhuis Gent Gent Belgium
Fondazione IRCCS San Gerardo Dei Tintori Monza Italy
University Hospital Ostrava Ostrava Czechia
Hopital Huriez Lille France
IRCCS Ospedale Sacro Cuore Don Calabria Negrar di Valpolicella Italy
Westfaelische Wilhelms Universitaet Muenster Munster Germany
Economicus Sp. z o.o. Katowice Poland
Hdywxcai Uttwuuippwmpv Muumswd Dt Vehctgaugx Santander Spain
Uklaqvxihhypfedlzuxah Mfakrfdz Arb Munster Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
18.06.2020
Bulgaria Bulgaria
Not recruiting
18.06.2020
Czechia Czechia
Not recruiting
18.06.2020
France France
Not recruiting
18.06.2020
Germany Germany
Not recruiting
18.06.2020
Greece Greece
Not recruiting
18.06.2020
Italy Italy
Not recruiting
18.06.2020
Poland Poland
Not recruiting
18.06.2020
Spain Spain
Not recruiting
18.06.2020

Trial locations

Investigated drugs:

Linerixibat is a medication being studied for its ability to help people with a condition called cholestatic pruritus, which causes severe itching. This itching is related to a liver disease known as Primary Biliary Cholangitis (PBC). The main goal of using linerixibat in this study is to see if it is safe and can be tolerated by patients over a long period. By taking this medication, patients may experience relief from the persistent itching that comes with their liver condition, potentially improving their quality of life.

Cholestasis – Cholestasis is a condition where the flow of bile from the liver is reduced or blocked. This can lead to a buildup of bile acids in the liver and bloodstream. Over time, this accumulation can cause symptoms such as jaundice, dark urine, pale stools, and itching. The condition can be intrahepatic, originating within the liver, or extrahepatic, occurring outside the liver. As cholestasis progresses, it may lead to liver damage due to the toxic effects of bile acids. The severity and progression of symptoms can vary depending on the underlying cause and extent of bile flow obstruction.

Trial ID:
2023-503465-33-00
Protocol code:
212358
NCT ID:
NCT04124965
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • Study of Seladelpar Treatment in Patients with Primary Biliary Cholangitis and Compensated Cirrhosis

    Recruiting

    3 1
    Investigated drugs:
    Austria Belgium Czechia Denmark France Germany +7
  • Study on Bezafibrate for Patients with Primary Biliary Cholangitis Not Responding Well to Ursodeoxycholic Acid

    Recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    France