Efficacy and Safety of Odevixibat in Patients With Alagille Syndrome (ASSERT)
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|ClinicalTrials.gov Identifier: NCT04674761|
Recruitment Status : Active, not recruiting
First Posted : December 19, 2020
Last Update Posted : March 31, 2022
|Condition or disease||Intervention/treatment||Phase|
|Alagille Syndrome||Drug: Odevixibat Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||63 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Phase 3 Double-blind, Randomized, Placebo-controlled Study of the Safety and Efficacy of Odevixibat (A4250) in Patients With Alagille Syndrome (ASSERT)|
|Actual Study Start Date :||March 19, 2021|
|Estimated Primary Completion Date :||October 2022|
|Estimated Study Completion Date :||October 2022|
Experimental: Odevixibat (A4250)
Capsules for oral administration once daily for 24 weeks.
Odevixibat is a small molecule and selective inhibitor of IBAT.
Other Name: A4250
Placebo Comparator: Placebo
Capsules for oral administration (to match active) once daily for 24 weeks.
Placebo identical in appearance to experimental drug (odevixibat).
- Change from Baseline in Scratching Score [ Time Frame: From baseline to Week 24 ]Change from baseline in scratching score to Month 6 as measured by the Albireo Observer-Reported Outcome scratching score
- Serum Bile Acid Levels [ Time Frame: From baseline to Week 24 ]Change in serum bile acid levels from baseline to Week 24
- Safety and Tolerability [ Time Frame: From first dose of study drug up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first ]Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04674761