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NCT01249092 · ClinicalTrials.gov registry record · Phase 2
Pentoxifylline for Primary Biliary Cirrhosis
A Phase 2 study, sponsored by The Cleveland Clinic.
- Completed
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
NCT01249092 is a Phase 2 study that has completed, run by The Cleveland Clinic. The registered enrollment target is 20 participants.
The verdict
NCT01249092, a Phase 2 study, has completed, sponsored by The Cleveland Clinic.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
Study 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.
Interventions
- DRUG Pentoxifylline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2010-11 |
| Est. Completion | 2013-03 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01249092
The ClinicalTrials.gov registry entry for NCT01249092 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The Cleveland Clinic, which has 688 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Pentoxifylline is the first listed.
NCT01249092 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01249092 about?
NCT01249092 is a clinical study titled "Pentoxifylline for Primary Biliary Cirrhosis". 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 ...
What is the current status of trial NCT01249092?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2010-11. Estimated completion is 2013-03.
What interventions are being tested in trial NCT01249092?
The interventions under investigation include: Pentoxifylline (DRUG).
Who is sponsoring clinical trial NCT01249092?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
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