Pentoxifylline for Primary Biliary Cirrhosis
Primary biliary cirrhosis (PBC) is cholestatic liver disease characterized by progressive destruction of small bile ducts within the liver that can lead to end stage liver disease and all its complications.
Although ursodeoxycholic acid (UDCA) is associated with increased survival in many patients with PBC, there is absence of an adequate response to UDCA in a significant proportion of PBC patients.
Tumor necrosis factor alpha (TNF-alpha) is a cytokine that plays an important role in the pathogenesis of PBC. Pentoxifylline (PTX) is a methylxanthine derivative that inhibits production of TNF-alpha. Furthermore, PTX has well known clinical and safety profiles. The main hypothesis of this study is that therapy with pentoxifylline (PTX) will result in improvement of liver disease in PBC patients who are incomplete responders to UDCA.
The focus of this proposal is on the effectiveness of PTX in improving laboratory parameters of liver disease and levels of cytokines involved in the pathogenesis of the disease in patients with PBC.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Study of Pentoxifylline for the Treatment of Primary Biliary Cirrhosis|
- Improvement of serum alkaline phosphatase levels. [ Time Frame: 6 months ] [ Designated as safety issue: No ]Serum alkaline phosphatase levels at entry, at 3 months, and at 6 months of therapy with PTX will be measured and compared.
- Serum levels of cytokines including TNF-alpha. [ Time Frame: 6 months ] [ Designated as safety issue: No ]Levels of cytokines of interest, including TNF-alpha, at entry and after PTX therapy will be measured and compared.
- Safety of therapy with PTX in patients with PBC will be assessed [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]Adverse effects occurring during the study will be compared with the established adverse effects profile of PTX
|Study Start Date:||November 2010|
|Estimated Study Completion Date:||December 2012|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|