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NCT00590161 · ClinicalTrials.gov registry record · Phase 2
Pentoxifylline in Patients With Nonalcoholic Steatohepatitis
A Phase 2 study, sponsored by Case Western Reserve University.
- Completed
- Registry status
- Phase 2
- Development phase
- 55
- Enrollment target
NCT00590161: Completed Phase 2 study, sponsored by Case Western Reserve University.
NCT00590161 is a Phase 2 study that has completed, run by Case Western Reserve University. The registered enrollment target is 55 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (59% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00590161, a Phase 2 study, has completed, sponsored by Case Western Reserve University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 55 participants
- Enrollment target
Study Summary
One third of the population in the United States has nonalcoholic fatty liver disease (NAFLD). Nonalcoholic steatohepatitis (NASH), the progressive form of NAFLD, can lead to cirrhosis.Currently, there is no proven therapy for patients with NASH. The investigators core hypothesis is that therapy of patients with NASH with pentoxifylline (PTX) for one year will result in improvement of biochemical parameters of liver disease and hepatic histology. The focus of this proposal is on the effectiveness of pentoxifylline (PTX) in improving laboratory and tissue parameters of liver disease, parameters of insulin-resistance, and levels of cytokines in patients with NASH.
Primary Outcome
The NAFLD Activity Score (NAS) grades NAFLD on liver biopsy based on the individual scoring of steatosis, inflammation and balloning. The NAS is assessed on a scale of 0 to 8 with higher scores indicating more severe disease and lower scores indicating less severe disease. NAS is obtained by adding steatosis(assessed on a scale of 0 to 3), inflammation (assessed on a scale of 0 to 3) and ballooning (assessed on a scale of 0 to 2).
Interventions
- DRUG placebo
- DRUG pentoxifylline (PTX)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2006-12 |
| Est. Completion | 2010-12 |
| Phase | Phase 2 |
What the finished NCT00590161 record still lists
NCT00590161 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (59% lower).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00590161 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00590161 about?
NCT00590161 is a clinical study titled "Pentoxifylline in Patients With Nonalcoholic Steatohepatitis". One third of the population in the United States has nonalcoholic fatty liver disease (NAFLD). Nonalcoholic steatohepatitis (NASH), the progressive form of NAFLD, can lead to cirrhosis.Currently, there is no proven therapy for patients with NASH. The investigators core hypothesis is that therapy of ...
What is the current status of trial NCT00590161?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 55 participants. The study started on 2006-12. Estimated completion is 2010-12.
What interventions are being tested in trial NCT00590161?
The interventions under investigation include: placebo (DRUG), pentoxifylline (PTX) (DRUG).
Who is sponsoring clinical trial NCT00590161?
This trial is sponsored by Case Western Reserve University, which has 141 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00590161's enrollment target sits among peer trials
55 1153rd of 2000 higher than 841 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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