Ignite Creation Date:
2024-05-06 @ 7:09 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05919433
Status:
RECRUITING
Last Update Posted:
2023-06-26
First Post:
2023-05-29
Brief Title:
Detection Program for Patients With Primary Biliary Cholangitis Lost in the System
Sponsor:
Hospital Mutua de Terrassa
Organization:
Hospital Mutua de Terrassa
Study Overview
Official Title:
Detection Program for Patients With Primary Biliary Cholangitis Lost in the System
Status:
RECRUITING
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RESCAT
Brief Summary:
Primary biliary cholangitis PBC has been considered a rare disease and its management has been limited by the lack of therapeutic alternatives PBC is a slowly progressing chronic liver disease characterized by an immune-mediated destruction of the intrahepatic bile ducts which leads to cholestasis portal inflammation and ultimately liver cirrhosis and its associated complications ascites portal hypertension etc if not treated effectively Thus early diagnosis and close management of these patients with PBC is essential First-line treatment with ursodeoxycholic acid UDCA improves liver biochemical parameters delays histological progression and increases liver transplant-free survival and overall survival However up to 40 of patients are non-responders to UDCA Obeticholic acid OCA is recommended as second-line therapy in combination with UDCA for patients with an inadequate response to UDCA or as monotherapy in cases of UDCA intolerance
According to current clinical guidelines the diagnosis of PBC includes a combination of elevated alkaline phosphatase ALP levels and the presence of anti-mitochondrial antibodies AMA titer 140 andor anti-nuclear antibodies ANA anti-gp210 or anti-sp100 AMA are highly sensitive and specific for PBC and are detected in nearly 95 of PBC patients A liver biopsy is not necessary unless there is an elevation of ALP without the presence of specific AMA andor anti-gp210 or anti-sp100 ANA or if coexistence with other liver diseases is suspected autoimmune hepatitis hepatic steatosis
The incidence of PBC has increased in recent years due to an increase in the diagnosis of cases in the initial phases better awareness in the medical community and the development of more sensitive diagnostic tests However up to 31 of patients with PBC are lost without follow-up The correct identification of patients with PBC is essential so that they can benefit from an adequate treatment and modify disease progression To date two studies one Spanish and one Portuguese showed that 27 and 455 of the patients lost with PBC presented advanced fibrosis respectively
The objective of this study is to identify through computerized data patients with PBC who may be lost in the system and evaluate their clinical analytical and demographic characteristics and in a second phase provide access to follow-up in specialized consultations
According to current clinical guidelines the diagnosis of PBC includes a combination of elevated alkaline phosphatase ALP levels and the presence of anti-mitochondrial antibodies AMA titer 140 andor anti-nuclear antibodies ANA anti-gp210 or anti-sp100 AMA are highly sensitive and specific for PBC and are detected in nearly 95 of PBC patients A liver biopsy is not necessary unless there is an elevation of ALP without the presence of specific AMA andor anti-gp210 or anti-sp100 ANA or if coexistence with other liver diseases is suspected autoimmune hepatitis hepatic steatosis
The incidence of PBC has increased in recent years due to an increase in the diagnosis of cases in the initial phases better awareness in the medical community and the development of more sensitive diagnostic tests However up to 31 of patients with PBC are lost without follow-up The correct identification of patients with PBC is essential so that they can benefit from an adequate treatment and modify disease progression To date two studies one Spanish and one Portuguese showed that 27 and 455 of the patients lost with PBC presented advanced fibrosis respectively
The objective of this study is to identify through computerized data patients with PBC who may be lost in the system and evaluate their clinical analytical and demographic characteristics and in a second phase provide access to follow-up in specialized consultations
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None