Loading clinical trials...

Pentoxifylline for Primary Biliary Cirrhosis | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Pentoxifylline for Primary Biliary Cirrhosis

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

NCT01249092•The Cleveland Clinic

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.

Eligibility

Age

18 - 76 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male and female patients ages 18 to 76 years.
•Established diagnosis of PBC based on at least three of the following criteria:
•* Detectable anti-mitochondrial antibodies (AMA)
•* Cholestatic biochemical pattern
•* Liver biopsy compatible with PBC
•* Appropriate exclusion of other liver diseases.
•Therapy with UDCA at adequate dose (13-15mg/kg/d) for at least six months and evidence of suboptimal response defined by alkaline phosphatase levels that did not normalize and remain elevated by at least 1.5 times the upper limit of normal.
•No history or present hepatic decompensation (e.g. variceal hemorrhage, encephalopathy, or poorly controlled ascites).

Exclusion Criteria

•Findings highly suggestive of liver disease of other etiology.
•A score \>=10 points on the Revised Scoring System for autoimmune hepatitis (AIH), supporting a diagnosis of PBC/AIH overlap.
•Patients on steroids (systemic), immunosuppressants, or immunomodulatory agents within the previous 6 months.
•Patients with clinical or laboratory evidence suggestive of decompensated cirrhosis.
•Hypersensitivity to PTX or the methylxanthines (caffeine, theophylline, theobromine).
•History of cerebral or retinal hemorrhage.
•Other medical comorbidities (such as cardiac, renal, cancer) that would interfere with completion of the study.
•Patients taking Theophylline or Coumadin because of potential drug-drug interactions with PTX. In addition, patients taking low molecular weight heparin preparations.
•Pregnant or nursing women.

Locations (1)

Cleveland Clinic

Cleveland, Ohio, United States

Key Dates

Start Date

November 1, 2010

Primary Completion Date

June 1, 2012

Completion Date

March 1, 2013

Last Updated

December 9, 2013

Enrollment

ACTUAL participants

Conditions

Primary Biliary Cirrhosis

Interventions

Pentoxifylline

DRUG

Study of Seladelpar in Participants With Primary Biliary Cholangitis (PBC)

NCT03301506

Primary Biliary Cirrhosis

View study

COMPLETED

The Health Burden of Primary Biliary Cirrhosis (PBC) in Switzerland

NCT02846896

Primary Biliary Cirrhosis

View study

COMPLETEDPHASE2

Study to Evaluate Safety, Tolerability and Efficacy of Saroglitazar Mg in Patients With Primary Biliary Cholangitis

NCT03112681

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 9, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Pentoxifylline for Primary Biliary Cirrhosis

Inclusion Criteria

Exclusion Criteria

Study of Seladelpar in Participants With Primary Biliary Cholangitis (PBC)

The Health Burden of Primary Biliary Cirrhosis (PBC) in Switzerland

Study to Evaluate Safety, Tolerability and Efficacy of Saroglitazar Mg in Patients With Primary Biliary Cholangitis

A Safety and Pharmakokinetic Study of A4250 Alone or in Combination With A3384

An Open-label Study to Evaluate the Long-term Safety and Tolerability of LUM001 in Patients With Primary Biliary Cirrhosis

Development of Ursodeoxycholic Acid 300 mg at Hospital Das Clinicas of the University of São Paulo School of Medicine