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| Sponsor: | Case Western Reserve University |
|---|---|
| Information provided by: | Case Western Reserve University |
| ClinicalTrials.gov Identifier: | NCT00590161 |
Purpose
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. Our core hypothesis is that therapy of patients with NASH with pentoxifylline 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 in improving laboratory and tissue parameters of liver disease, parameters of insulin-resistance, and levels of cytokines in patients with NASH.
| Condition | Intervention | Phase |
|---|---|---|
|
Nonalcoholic Steatohepatitis |
Drug: pentoxifylline Drug: placebo |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Treatment Efficacy of Pentoxifylline in Patients With Nonalcoholic Steatohepatitis: A Double-Blind Randomized Placebo Controlled Trial |
| Estimated Enrollment: | 64 |
| Study Start Date: | December 2006 |
| Estimated Study Completion Date: | June 2009 |
| Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Pentoxifylline 400 mg PO tid
|
Drug: pentoxifylline
400 mg PO tid
|
|
2: Placebo Comparator
Placebo tid
|
Drug: placebo
placebo tid
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Claudia O Zein, MD, MSc | 216-791-3800 ext 5259 | claudia.zein@case.edu |
| Contact: Beth Bednarchik, RN | 216-844-7314 | Beth.bednarchik@uhhs.org |
| United States, Ohio | |
| Louis Stokes VA Medical Center | Recruiting |
| Cleveland, Ohio, United States, 44106 | |
| Contact: Claudia O Zein, MD, MSc 216-791-3800 ext 5259 claudia.zein@case.edu | |
| Contact: Beth Bednarchik, RN 216-844-7314 beth.bednarchik@uhhs.org | |
| Principal Investigator: Claudia O. Zein, MD, MSc | |
| University Hospitals Case Medical Center | Recruiting |
| Cleveland, Ohio, United States, 44106 | |
| Contact: Beth Bednarchik, RN 216-844-7314 beth.bednarchik@uhhs.org | |
| Principal Investigator: Claudia O Zein, MD, MSc | |
| Sub-Investigator: Anthony B. Post, MD | |
| Sub-Investigator: Pierre M. Gholam, MD | |
| Cleveland Clinic | Recruiting |
| Cleveland, Ohio, United States, 44195 | |
| Contact: Ruth Sargent, LPN 216-444-3126 sargenr@ccf.org | |
| Principal Investigator: Arthur J McCullough, MD | |
| Metrohealth Medical Center | Not yet recruiting |
| Cleveland, Ohio, United States, 44109 | |
| Principal Investigator: | Claudia O Zein, MD, MSc | Case Western Reserve University |
More Information
| Responsible Party: | Case Western Reserve University, Louis Stokes VA Medical Center ( Claudia O. Zein, MD, MSc ) |
| Study ID Numbers: | R-1196 CWRU CRU |
| Study First Received: | December 26, 2007 |
| Last Updated: | December 26, 2007 |
| ClinicalTrials.gov Identifier: | NCT00590161 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Fatty Liver Nonalcoholic fatty liver disease NAFLD |
Nonalcoholic steatohepatitis NASH pentoxifylline |
|
Vasodilator Agents Liver Diseases Radiation-Protective Agents Antioxidants Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Hematologic Agents Fatty Liver Enzyme Inhibitors |
Cardiovascular Agents Protective Agents Pentoxifylline Pharmacologic Actions Digestive System Diseases Phosphodiesterase Inhibitors Therapeutic Uses Free Radical Scavengers Platelet Aggregation Inhibitors |