Alagille Syndrome Clinical Trial
Official title:
The Evaluation of the Intestinal Bile Acid Transport (IBAT) Inhibitor LUM001 in the Reduction of Pruritus in Alagille Syndrome, a Cholestatic Liver Disease
The study is a randomized, double-blind, placebo-controlled study in children with Alagille Syndrome (ALGS). The study will investigate the effects of LUM001, compared to placebo, on pruritus, serum bile acids, liver enzymes, and other biochemical markers in patients with ALGS.
n/a
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT04729751 -
A Study to Evaluate the Safety and Tolerability of Maralixibat in Infant Participants With Cholestatic Liver Diseases Including Progressive Familial Intrahepatic Cholestasis (PFIC) and Alagille Syndrome (ALGS).
|
Phase 2 | |
Active, not recruiting |
NCT05035030 -
Long-term Safety and Efficacy of Odevixibat in Patients With Alagille Syndrome
|
Phase 3 | |
Recruiting |
NCT06193928 -
Long-Term Safety and Clinical Outcomes of Livmarli in Patients With Alagille Syndrome (LEAP)
|
||
Completed |
NCT02160782 -
Safety and Efficacy Study of LUM001 (Maralixibat) With a Drug Withdrawal Period in Participants With Alagille Syndrome (ALGS)
|
Phase 2 | |
Completed |
NCT00007033 -
Study of Magnesium Sulfate in Children With Reduced Bone Density Secondary to Chronic Cholestatic Liver Disease
|
N/A | |
Suspended |
NCT00571272 -
Longitudinal Study of Genetic Causes of Intrahepatic Cholestasis (LOGIC)
|
||
Active, not recruiting |
NCT02922751 -
FibroScan™ in Pediatric Cholestatic Liver Disease (FORCE)
|
||
Completed |
NCT00001642 -
Positional Cloning of the Gene(s) Responsible for Alagille Syndrome
|
N/A | |
Recruiting |
NCT05488067 -
Atorvastatin Therapy on Xanthoma in Alagille Syndrome
|
Phase 4 | |
Completed |
NCT04674761 -
Efficacy and Safety of Odevixibat in Patients With Alagille Syndrome
|
Phase 3 | |
Completed |
NCT02117713 -
An Extension Study to Evaluate the Long-Term Safety and Durability of Effect of LUM001 in the Treatment of Cholestatic Liver Disease in Pediatric Subjects With Alagille Syndrome
|
Phase 2 | |
Completed |
NCT02131623 -
Validation of the Itch Reported Outcome (ItchRO) Diaries in Pediatric Cholestatic Liver Disease
|
||
Completed |
NCT02963077 -
A Safety and Pharmakokinetic Study of A4250 Alone or in Combination With A3384
|
Phase 1 | |
Recruiting |
NCT01793168 -
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
|
||
Completed |
NCT03082937 -
An Open Label, Single-dose, Single Period ADME Study of A4250 in Healthy Subjects
|
Phase 1 | |
Completed |
NCT02047318 -
An Extension Study to Evaluate the Long-Term Safety and Durability of Effect of LUM001 in the Treatment of Cholestatic Liver Disease in Subjects With Alagille Syndrome (ALGS)
|
Phase 2 | |
Completed |
NCT01903460 -
Safety and Efficacy Study of LUM001 in the Treatment of Cholestatic Liver Disease in Patients With Alagille Syndrome
|
Phase 2 | |
Completed |
NCT01515631 -
Characterization of Pulmonary Artery Stenoses in Alagille Syndrome - a Medical Record Review
|
||
Enrolling by invitation |
NCT05846854 -
Decreasing Hemorrhage Risk in Children With Alagille Syndrome
|
N/A | |
Approved for marketing |
NCT04530994 -
A Maralixibat Expanded Access Program for Patients With Cholestatic Pruritus Associated With Alagille Syndrome (ALGS)
|