An Open Label Study to Evaluate the Long-term Safety and Efficacy of Odevixibat (A4250) in Patients with Alagille Syndrome (ASSERT-EXT)
- Conditions
- Alagille Syndrome10019806
- Registration Number
- NL-OMON54015
- Lead Sponsor
- Albireo AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 6
1. Completion of the 24-week Treatment Period of Study A4250-012;
2. Signed informed consent and assent as appropriate. Patients who turn 18
years of age (or legal age per country) during the study will be required to
re-consent to remain on the study;
3. Caregivers (and age-appropriate patients) must be willing and able to use an
electronic diary (eDiary) device as required by the study;
4. Sexually active males and females must agree to use a reliable contraceptive
method with <= 1% failure rate (such as intra-uterine device, or complete
abstinence) from signed informed consent through 90 days after last dose of
study drug;
1. Decompensated liver disease, history or presence of clinically significant
ascites, variceal hemorrhage, and/or encephalopathy;
2. Patients who were not compliant with study drug treatment or procedures in
Study A4250-012;
3. Any other conditions or abnormalities which, in the opinion of the
investigator, may compromise the safety of the patient, or interfere with the
patient participating in or completing the study;
4. Known hypersensitivity to any components of odevixibat;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Change from baseline in scratching through Week 72 as measured by the Albireo<br /><br>observer-reported outcomes (ObsRO) caregiver instrument</p><br>
- Secondary Outcome Measures
Name Time Method