|
Treating Nonalcoholic Steatohepatitis with Pioglitazone Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on Treating Nonalcoholic Steatohepatitis with Pioglitazone conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Treating Nonalcoholic Steatohepatitis with Pioglitazone Clinical research trials and Treating Nonalcoholic Steatohepatitis with Pioglitazone medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like Treating Nonalcoholic Steatohepatitis with Pioglitazone. Treating Nonalcoholic Steatohepatitis with Pioglitazone Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a Treating Nonalcoholic Steatohepatitis with Pioglitazone clinical trial. Subjects typically recieve the finest healthcare available for their Treating Nonalcoholic Steatohepatitis with Pioglitazone condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "T" Clinical Trials Conditions > Treating Nonalcoholic Steatohepatitis with Pioglitazone  Treating Nonalcoholic Steatohepatitis with Pioglitazone
Treating Nonalcoholic Steatohepatitis with Pioglitazone
For Condition: Hepatitis
Status: Recruiting
Sponsor(s): National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) ,
Synopsis: Nonalcoholic steatohepatitis (NASH) is a chronic liver disease with an unknown cause. It can lead to cirrhosis of the liver in about 10 percent of patients and injury and scarring of the liver in another 30 percent. At present there are no approved treatments for NASH. The purpose of this study is to continue an experimental approach to improve insulin sensitivity in persons with NASH with a medication called pioglitazone. This study, which will last for three to five years, is designed to allow for retreatment of patients who took part in a previous study of a 48-week course of pioglitazone for NASH. Between 20 and 30 patients will participate in the study. Participants will be admitted to the NIH Clinical Center for two to three days, where they will undergo a complete medical history and physical exam, a series of lab studies, and a liver biopsy. They will then start taking pioglitazone as a 15mg tablet once daily. Throughout the study, participants will be evaluated periodically to gauge their progress via blood work, MRI scans, and other evaluative tests.
Details: Nonalcoholic steatohepatitis (NASH) is a common liver disease that resembles alcoholic hepatitis but occurs in persons who drink little or no alcohol. The etiology of NASH is unclear, but it is commonly associated with diabetes, obesity, and insulin resistance. Several pilot studies, including a study of pioglitazone at the NIH Clinical Center (01-DK-0130), have shown that the insulin-sensitizing thiazolidinediones lead to decreases in serum alanine aminotransferase (ALT) levels and improved liver histology. Once therapy is stopped, however, ALT levels rapidly return to pre-treatment values. In the current study, patients who have completed the pilot study and have been off of pioglitazone for 48 weeks will be offered re-treatment for 3 years. After a repeat medical and metabolic evaluation and liver biopsy, patients with moderate-to-severe NASH (activity score greater than or equal to 4) will restart pioglitazone at a dose of 15 mg daily. If after 48 weeks, ALT levels are not normal or improved to the degree identified during the pilot study, the dose will be increased to 30 mg daily (the dose used in the pilot study). At the end of 3 years, patients will undergo repeat medical and metabolic evaluation and liver biopsy. The primary end point will be improvement in liver histology. Secondary end points will be improvements in insulin sensitivity, reduction in visceral fat, liver volume, and liver biochemistry. The aim of this study is to evaluate whether long-term pioglitazone therapy can safely achieve and maintain biochemical and histological improvements in NASH.
Eligibility:
Study Type: Interventional, Treatment, Safety/Efficacy
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: Completion of a 48-week course of pioglitazone in protocol 01-DK-0130. At least 48 weeks of follow up on no thiazolidinedione therapy after completion of protocol 01-DK-0130. Written informed consent. Patients to receive pioglitazone in this protocol will also have to meet the following inclusion criteria: a. Demonstrated improvements in liver histology and/or serum ALT levels during the 48-week course of pioglitazone treatment in protocol 01-DK-0130. b. Elevations in serum ALT levels. c. Liver biopsy showing NASH with a total NASH activity score of at least 4 (of a total possible score of 16) including a score of at least 1 each for parenchyma inflammation, cellular injury and steatosis on liver biopsy taken 48 weeks after stopping pioglitazone. d. Willingness to receive pioglitazone for 3 years. EXCLUSION CRITERIA: Evidence of another form of liver disease (these largely will have been excluded based upon enrollment in the previous study, 01-DK-0130). a. Hepatitis B as defined as presence of hepatitis B surface antigen (HBsAg). b. Hepatitis C as defined by presence of hepatitis C virus (HCV) RNA in serum. c. Autoimmune hepatitis as defined by anti-nuclear antibody (ANA) of 1:160 or greater and liver histology consistent with autoimmune hepatitis or previous response to immunosuppressive therapy. d. Autoimmune cholestatic liver disorders as defined by elevation of alkaline phosphatase and anti-mitochondrial antibody of greater than 1:80 or liver histology consistent with primary biliary cirrhosis or elevation of alkaline phosphatase and liver histology consistent with sclerosing cholangitis. e. Wilson disease as defined by ceruloplasmin below the limits of normal and liver histology consistent with Wilson disease. f. Alpha-1-antitrypsin deficiency as defined by alpha-1-antitrypsin level less than normal and liver histology consistent with alpha-1-antitrypsin deficiency. g. Hemochromatosis as defined by presence of 3+ or 4 iron on liver biopsy stain and homozygosity for C282Y or compound heterozygosity for C282Y/H63D. h. Drug-induced liver disease as defined on the basis of typical exposure and history. i. Bile duct obstruction as shown by imaging studies. History of excess alcohol ingestion, averaging more than 30 gm/day (3 drinks per day) in the previous 10 years, or history of alcohol intake averaging greater than 10 gm/day (1 drink per day: 7 drinks per week) in the previous one year. Contraindications to liver biopsy: platelet counts less than 75,000/mm(3) or prothrombin time greater than 16 seconds. Decompensated liver disease, Child-Pugh score greater than or equal to 7 points. History of gastrointestinal bypass surgery or ingestion of drugs known to produce hepatic steatosis including corticosteroids, high-dose estrogens, methotrexate, tetracycline or amiodarone in the previous 6 months. Preexistent diabetes mellitus or the development of diabetes mellitus during the study requiring the use of another drug in addition to pioglitazone for glycaemic control. Diabetes being as defined by: fasting plasma glucose of greater than or equal to 126 mg/dl on two separate occasions, or diabetic symptoms with a random plasma glucose of greater than or equal to 200 mg/dl. Use of anti-diabetic drugs, including insulin, biguanides, sulfonylureas, or thiazolidinediones at the time of enrollment or in the previous 48 weeks. Significant systemic or major illnesses other than liver disease, including congestive heart failure, coronary artery disease, cerebrovascular disease, pulmonary disease, renal failure, organ transplantation, serious psychiatric disease, malignancy that, in the opinion of the investigator would preclude treatment with pioglitazone and adequate follow up. Positive test for anti-HIV. Active substance abuse, such as alcohol, inhaled or injection drugs within the previous one year. Pregnancy or inability to practice adequate contraception in women of childbearing potential. Evidence of hepatocellular carcinoma: alpha-fetoprotein levels greater than 200 ng/ml and/or liver mass on imaging study that is suggestive of liver cancer. Any other conditions, which, in the opinion of the investigators would impede competence or compliance or possibility, hinder completion of the study.
Total Enrollment: 30
Location and Contact Information:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Patient and Public Liaison Office 1-800-411-1222
Additional Information:
Study ID Numbers: 030212; 03-DK-0212
Study Start Date: June 10, 2003
Record last reviewed: March 9, 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00062764
Other Hepatitis Studies:
1. Telbivudine versus Lamivudine in Adults with Decompensated Chronic Hepatitis B and Evidence of Cirrhosis
2. Safety and Efficacy Study of a Caspase Inhibitor in Patients Undergoing Liver Transplantation
3. A Controlled Prospective Study of Transfusion-Associated Hepatitis
4. Treating Nonalcoholic Steatohepatitis with Pioglitazone
5. Hepatitis C: Grading and Staging by MR
Related Studies:
Other Hepatitis Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Treating Nonalcoholic Steatohepatitis with Pioglitazone
|
|
|
|
|
|
|
|
