NCT01249092

Pentoxifylline for Primary Biliary Cirrhosis

A Pilot Study of Pentoxifylline for the Treatment of Primary Biliary Cirrhosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: The Cleveland Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 76 Years
• Healthy volunteers: Not accepted

Summary

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. Other fibrosis biomarkers such as tissue metallo proteinase 1 (TIMP-1) are associated with progression of liver fibrosis in PBC. Pentoxifylline (PTX) is a methylxanthine derivative that inhibits pro-inflammatory cytokines and also has shown anti-fibrotic effects in serum of patients with PBC. 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.

Conditions

• Primary Biliary Cirrhosis

Interventions

Type	Name	Description
DRUG	Pentoxifylline	Patients will take 400mg of pentoxifylline three times daily for a total duration of 6 months.

Timeline

• Start date: 2010-11-01
• Primary completion: 2012-06-01
• Completion: 2013-03-01
• First posted: 2010-11-29
• Last updated: 2013-12-09
• Results posted: 2013-12-09

Locations

1 site across 1 country: United States