| Trial ID: | L0763 |
| Source ID: | NCT00063622
|
| Associated Drug: |
Vitamin E
|
| Title: |
Clinical Research Network in Nonalcoholic Steatohepatitis: Pioglitazone vs. Vitamin E vs. Placebo for the Treatment of Non-Diabetic Patients With Nonalcoholic Steatohepatitis (PIVENS)
|
| Acronym: |
PIVENS
|
| Status: |
Not recruiting
|
| Study Results: |
Has Results
|
| Results: |
https://clinicaltrials.gov/ct2/show/results/NCT00063622
|
| Conditions: |
Liver Diseases
|
| Interventions: |
Drug: Pioglitazone;Dietary Supplement: Vitamin E;Drug: Matching placebo
|
| Outcome Measures: |
Number of Participants With Improvement in Non-alcoholic Fatty Liver Disease (NAFLD) Activity Defined by Change in Standardized Scoring of Liver Biopsies at Baseline and After 96 Weeks of Treatment.Number of Participants With Improvement in Steatosis;Number of Participants With Improvement in Lobular Inflammation;Number of Participants With Improvement in Hepatocellular Ballooning;Number of Participants With Improvement in Fibrosis;Number of Participants With Resolution of Definite Nonalcoholic Steatohepatitis
|
| Sponsor/Collaborators: |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
|
| Gender: |
All
|
| Age: |
18 Yearsnan
|
| Phases: |
Phase 3
|
| Enrollment: |
247
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
|
| Start Date: |
01/07/2003
|
| Completion Date: |
--
|
| Results First Posted: |
01/08/2012
|
| Last Update Posted: |
12 December 2020
|
| Locations: |
United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00063622
|
