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NCT00593658 · ClinicalTrials.gov registry record · Phase 1
Pilot Study of Pentoxifylline for Hepatopulmonary Syndrome
A Phase 1 study, sponsored by University of Alabama at Birmingham.
- Terminated
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
NCT00593658 is a Phase 1 study that was terminated before completion, run by University of Alabama at Birmingham. The registered enrollment target is 9 participants.
The verdict
NCT00593658, a Phase 1 study, was terminated before completion, sponsored by University of Alabama at Birmingham.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
Study 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.
Interventions
- DRUG pentoxifylline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2004-06 |
| Est. Completion | 2006-10 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00593658
The ClinicalTrials.gov registry entry for NCT00593658 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Alabama at Birmingham, which has 1,160 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which pentoxifylline is the first listed.
NCT00593658 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00593658 about?
NCT00593658 is a clinical study titled "Pilot Study of Pentoxifylline for Hepatopulmonary Syndrome". 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 ...
What is the current status of trial NCT00593658?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2004-06. Estimated completion is 2006-10.
What interventions are being tested in trial NCT00593658?
The interventions under investigation include: pentoxifylline (DRUG).
Who is sponsoring clinical trial NCT00593658?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
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