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Study Summary
This trial is testing a new medication for children with a rare liver disease. The goal is to see if it is safe and effective over the long term.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2020 Phase 3 trial • 62 Patients • NCT03566238Trial Design
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- I have a condition that affects how my body processes medication.I have PFIC and have experienced significant itching, noted by myself or my caregiver.I am taking medication that affects bile acid, lipids, or slows my digestion.My INR is above 1.4, but I can be treated to lower it for inclusion.I have not been part of any medical study or taken any experimental drugs or used any experimental devices in the last 30 days or 5 half-lives of the study agent, whichever is longer.I have PFIC with bile acid levels ≥100 μmol/L, confirmed by 2 tests.I (or my guardian) have signed the consent form, and I will sign again if I turn 18 during the study.I have PFIC with current severe itching and high bile acid levels.I have severe liver disease with symptoms like bleeding, fluid buildup, or confusion.I am sexually active and use reliable contraception or practice complete abstinence.I have a liver condition other than PFIC, but may have significant portal hypertension.I have cancer, but it's not basal cell carcinoma or a non-liver cancer treated over 5 years ago without recurrence.I have had a liver transplant or will have one within 6 months.I have a severe itching skin condition that doesn't respond to treatment.I have a genetic variation in the ABCB11 gene leading to no BSEP protein.I am willing to use an eDiary device for the study.I am using or will use effective birth control during and 90 days after the study.I have PFIC or BRIC, weigh at least 5 kg, and can be any age.I have had a significant infection or HIV in the past, but it's currently under control.I have a caregiver who will be with me throughout the study.I have had chronic diarrhea for over 3 months needing IV fluids or nutritional support.I have severe liver issues, including bleeding, fluid buildup, or mental confusion.I have a genetic confirmation of PFIC.
- Group 1: A4250
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Can elderly people participate in this research?
"This particular clinical trial is seeking participants between 0 months and 100 years old. In total, there are 34 clinical trials currently underway for patients in this age range."
What is known about A4250 (odevixibat) from other research?
"Currently, there are 3 ongoing clinical trials for A4250 (odevixibat), with the majority of those being in Phase 3. In addition, while most of the trials are being conducted in Barcelona and Maryland, there are a total of 133 locations running these studies."
Could I possibly qualify to take part in this clinical trial?
"This trial is enrolling 120 participants with cholestasis between the ages of 0 Months and 100. Most notable, applicants should meet the following criteria: Completion of the 24-week Treatment Period of Study A4250-005 or withdrawn from Study A4250-005 due to patient/caregiver judgment of intolerable symptoms after completing at least 12 weeks of treatment, Signed informed consent and assent as appropriate, Patient must have clinical genetic confirmation of PFIC, Patients with PFIC, excluding BRIC, must have elevated serum bile acid concentration,specifically measured to be ≥100 μmol/L, taken"
How does A4250 (odevixibat) impact patients safety?
"A4250 (odevixibat) has received a score of 3 from our analysts at Power. This is because in addition to being a Phase 3 trial, there is both efficacy and safety data supporting the use of A4250."
Are there any open vacancies for this clinical trial?
"Currently, this trial is not looking for new patients. The trial was first posted on September 28th, 2018 and was last updated on October 10th, 2022. If you are hoping to participate in other studies, there are 25 trials actively recruiting patients with cholestasis and 3 studies for A4250 (odevixibat) that have open enrollment."
Do we have a good number of participating clinics in our country for this research project?
"This clinical trial is currently looking for enrollees from a total of 12 sites. If you are considering participating in this study, please note that there are locations in Saint Louis, Atlanta and New york. To lessen your time commitment, please select the trial site that is nearest to you."
What is the unique factor about this clinical trial?
"Albireo first sponsored a clinical study for A4250 (odevixibat) in 2018. Since the first Phase 3 trial, which had 120 participants, there are now 3 active trials involving this medication. These trials are being conducted in 31 cities and 21 countries."
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