Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00062764
Status:
COMPLETED
Last Update Posted:
2012-12-19
First Post:
2003-06-12
Brief Title:
Treating Nonalcoholic Steatohepatitis With Pioglitazone
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Long-Term Treatment of Nonalcoholic Steatohepatitis With Pioglitazone
Status:
COMPLETED
Status Verified Date:
2012-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 Inaddition we are currently enrolling patients with NASH in a pilot study of metformin therapy for 48-weeks however our results in 3 patients thus far have not been very encouraging
In the current study patients who have completed the pilot study of pioglitazone and have been off therapy for 48 weeks will be offered re-treatment for 3 years We also propose to treat patients who have not had a satisfactory response to metformin with pioglitazone for the same duration 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 at the end of 3 years all 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
In the current study patients who have completed the pilot study of pioglitazone and have been off therapy for 48 weeks will be offered re-treatment for 3 years We also propose to treat patients who have not had a satisfactory response to metformin with pioglitazone for the same duration 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 at the end of 3 years all 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
Detailed Description:
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 Inaddition we are currently enrolling patients with NASH in a pilot study of metformin therapy for 48-weeks however our results in 3 patients thus far have not been very encouraging
In the current study patients who have completed the pilot study of pioglitazone and have been off therapy for 48 weeks will be offered re-treatment for 3 years We also propose to treat patients who have not had a satisfactory response to metformin with pioglitazone for the same duration 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 at the end of 3 years all 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
In the current study patients who have completed the pilot study of pioglitazone and have been off therapy for 48 weeks will be offered re-treatment for 3 years We also propose to treat patients who have not had a satisfactory response to metformin with pioglitazone for the same duration 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 at the end of 3 years all 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 03-DK-0212 | None | None | None |