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Pilot Study of Pentoxifylline for Hepatopulmonary Syndrome

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ClinicalTrials.gov Identifier: NCT00593658
Recruitment Status : Terminated (Poor tolerability of drug and side effects)
First Posted : January 15, 2008
Last Update Posted : March 9, 2015
Information provided by:
University of Alabama at Birmingham

Brief Summary:

The Hepatopulmonary syndrome (HPS) results from intrapulmonary microvascular dilatation that impairs arterial oxygenation in the setting of cirrhosis or portal hypertension. As many as 10-20% of cirrhotics being evaluated for orthotopic liver transplantation (OLT) have advanced HPS and mortality is greater in those with HPS than in those without HPS. Currently, OLT is the only effective treatment, although post-operative mortality in HPS is increased relative to cirrhotic patients without HPS, with a one-year survival of between 68-80 %. Therefore, an effective medical therapy for advanced HPS could improve both pre-operative and post-operative mortality.

Recent work in experimental models of HPS has revealed that both nitric oxide synthase-derived nitric oxide and heme oxygenase-derived carbon monoxide cause intrapulmonary vasodilatation. These alterations appear to be driven in part by TNF-α modulation of pulmonary blood flow and intravascular monocyte accumulation. Pentoxifylline is a nonspecific phosphodiesterase inhibitor with inhibitory effects on TNF-α and has recently been shown to be beneficial in patients with severe alcoholic hepatitis where TNF-α overproduction contributes to liver injury. In experimental HPS, pentoxifylline administration also decreases the severity of oxygenation abnormalities. However, pentoxifylline therapy has been associated with dose limiting side effects in patients with liver disease and the tolerability of pentoxifylline in cirrhotic patients with advanced HPS is unknown. Therefore, this open label single arm clinical trial was designed to evaluate the efficacy and tolerability of 8 weeks of pentoxifylline in cirrhotic patients with advanced HPS being considered for OLT.

Condition or disease Intervention/treatment Phase
Hepatopulmonary Syndrome Drug: pentoxifylline Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Label Single Arm Pilot Study of Pentoxifylline in Advanced Hepatopulmonary Syndrome
Study Start Date : June 2004
Actual Primary Completion Date : October 2006
Actual Study Completion Date : October 2006

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: single Drug: pentoxifylline
pentoxifylline extended release 800mg PO TID for 8 weeks

Primary Outcome Measures :
  1. change in arterial oxygenation (PaO2) and/or alveolar arterial oxygen gradient [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. adverse events and safety of pentoxifylline therapy [ Time Frame: 8 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patient undergoing liver transplantation evaluation for cirrhosis
  • HPS (positive contrast echocardiography, hypoxemia, no other cause)
  • PaO2 < 65mmHg
  • ability and willingness to give informed consent

Exclusion Criteria:

  • Patients under the age of 19
  • active bacterial infections
  • known malignancy
  • intrinsic cardiopulmonary disease
  • known intolerance to pentoxifylline

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00593658

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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
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Principal Investigator: Michael B Fallon, MD University of Alabama at Birmingham
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Michael B. Fallon, MD, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00593658    
Other Study ID Numbers: F030604005
R03DK065958 ( U.S. NIH Grant/Contract )
First Posted: January 15, 2008    Key Record Dates
Last Update Posted: March 9, 2015
Last Verified: January 2008
Keywords provided by University of Alabama at Birmingham:
liver transplantation evaluation
Additional relevant MeSH terms:
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Hepatopulmonary Syndrome
Pathologic Processes
Liver Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs
Vasodilator Agents
Free Radical Scavengers