Status:
COMPLETED
Pentoxifylline for Primary Biliary Cirrhosis
Lead Sponsor:
The Cleveland Clinic
Conditions:
Primary Biliary Cirrhosis
Eligibility:
All Genders
18-76 years
Phase:
PHASE2
Brief 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 complica...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01249092
Start Date
November 1 2010
End Date
March 1 2013
Last Update
December 9 2013
Active Locations (1)
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1
Cleveland Clinic
Cleveland, Ohio, United States, 44195