Alagille Syndrome Clinical Trial
Official title:
Characterization of Pulmonary Artery Stenoses in Alagille Syndrome - a Medical Record
NCT number | NCT01515631 |
Other study ID # | AG9031 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | April 2007 |
Est. completion date | February 2018 |
Verified date | September 2018 |
Source | Stanford University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Patients who have Alagille Syndrome (AGS) also frequently have blockages (or "stenoses") of their pulmonary arteries. Little is known about the degree or variability of these stenoses, or the effect of this disease on the right ventricle (the chamber of the heart which pumps blood to the lungs). This study will first quantify and describe pulmonary artery stenosis in patients with Alagille Syndrome. The study will also assess the effect of these stenoses on the right ventricle. The investigators hope to learn the degree and characteristics of pulmonary artery stenosis in Alagille Syndrome. The investigators also hope to learn the effect of this pulmonary artery stenosis on the right ventricle in patients with Alagille Syndrome. This information is critical in the management of patients with Alagille syndrome, as there is currently no data to guide clinicians on the management of pulmonary artery stenosis. Furthermore, the information from this study may help physicians manage pulmonary artery stenosis in other patients as well.
Status | Completed |
Enrollment | 25 |
Est. completion date | February 2018 |
Est. primary completion date | February 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Diagnosis of Alagille Syndrome Exclusion Criteria: |
Country | Name | City | State |
---|---|---|---|
United States | Lucile Packard Children's Hospital at Stanford | Palo Alto | California |
Lead Sponsor | Collaborator |
---|---|
Stanford University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Assessment of PA in Alagille Patient | Open |
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)
|
||
Completed |
NCT02057692 -
Evaluation of LUM001 in the Reduction of Pruritus in Alagille Syndrome
|
Phase 2 | |
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 | |
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)
|