Primary Biliary Cholangitis Clinical Trial
Official title:
Detection Program for Patients With Primary Biliary Cholangitis Lost in the System
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 >1:40) and/or 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 and/or 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 45.5% 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.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02516605 -
A Multi-part, Double Blind Study to Assess Safety, Tolerability and Efficacy of Tropifexor (LJN452) in PBC Patients
|
Phase 2 | |
| Recruiting |
NCT06051617 -
Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis
|
Phase 3 | |
| Recruiting |
NCT06060665 -
IDEAL: Intended to Determine the Effects of Seladelpar on Normalization of Alkaline Phosphatase Levels in Subjects With Primary Biliary Cholangitis (PBC) and an Incomplete Response or Intolerance to Ursodeoxycholic Acid (UDCA)
|
Phase 3 | |
| Recruiting |
NCT05450887 -
Efficacy and Safety of Obeticholic Acid in the Treatment of Primary Biliary Cholangitis
|
Phase 3 | |
| Recruiting |
NCT05050136 -
A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Biliary Cholangitis
|
Phase 2 | |
| Recruiting |
NCT04076527 -
Prospective, Multicenter Cohort Study on Primary Biliary Cholangitis
|
||
| Recruiting |
NCT05151809 -
National Database on Primary Biliary Cholangitis
|
||
| Recruiting |
NCT04950764 -
An Open-Label Study Following Oral Dosing of Seladelpar to Subjects With Primary Biliary Cholangitis (PBC) and Hepatic Impairment (HI)
|
Phase 1 | |
| Completed |
NCT03545672 -
Early Identification of Myocardial Impairment in PBC
|
||
| Completed |
NCT06098027 -
Study of [14C]CS0159 in China Healthy Subjects
|
Phase 1 | |
| Active, not recruiting |
NCT04594694 -
Study of OCA in Combination With BZF Evaluating Efficacy, Safety, and Tolerability in Participants With PBC
|
Phase 2 | |
| Completed |
NCT03602560 -
ENHANCE: Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA)
|
Phase 3 | |
| Suspended |
NCT03684187 -
Mindfulness - Based Intervention in the Treatment of Fatigue in Patients With Primary Biliary Cholangitis
|
N/A | |
| Recruiting |
NCT04617561 -
Ursodeoxycholic Acid Combined With Low Dose Glucocorticoid in the Treatment of PBC With AIH Features II
|
Phase 4 | |
| Terminated |
NCT03092765 -
Study of E6011 in Japanese Subjects With Primary Biliary Cholangitis Inadequately Responding to Ursodeoxycholic Acid
|
Phase 2 | |
| Completed |
NCT04604652 -
Open-Label Study of HTD1801 in Adult Subjects With Primary Biliary Cholangitis
|
Phase 2 | |
| Not yet recruiting |
NCT06417398 -
Preliminary Clinical Study of UTAA09 Injection in the Treatment of Relapsed/Refractory Autoimmune Diseases
|
Early Phase 1 | |
| Completed |
NCT06309589 -
The Effectiveness of Combining Ursodeoxycholic Acid With Vitamin D in Treating Patients With Primary Biliary Cholangitis
|
N/A | |
| Completed |
NCT05292872 -
Real-World Data Study to Evaluate the Effectiveness of OCA on Hepatic Outcomes in PBC Patients
|
||
| Withdrawn |
NCT05293938 -
A Real-World Data Study to Evaluate the Effectiveness of OCA on Hepatic Outcomes in PBC Patients
|