Safety and Efficacy of Roflumilast and Pioglitazone in Treating Adults With Nonalcoholic SteatoHepatitis
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Randomized, Double-Blind, Controlled, Multi-Center Phase 2 Study to Evaluate the Effect of Roflumilast Plus Pioglitazone on Liver Enzymes and Liver Fat Content in Subjects With Nonalcoholic SteatoHepatitis|
- Percent Change from Baseline in Serum Alanine Transaminase (ALT) [ Time Frame: Baseline and Month 4 ] [ Designated as safety issue: No ]Serum alanine transaminase will be measured from blood samples taken at Baseline and Month 4.
- Percent Change from Baseline in Serum Aspartate Transaminase (AST) [ Time Frame: Baseline and Month 4 ] [ Designated as safety issue: No ]Serum aspartate transaminase will be measured from blood samples taken at Baseline and Month 4.
- Change from Baseline in Liver Fat Content at 4 Months [ Time Frame: Baseline and Month 4 ] [ Designated as safety issue: No ]Liver fat will be measured using abdominal Magnetic Resonance Imaging (MRI).
|Study Start Date:||June 2013|
|Study Completion Date:||September 2014|
|Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
Experimental: Roflumilast + pioglitazone
Roflumilast dose and pioglitazone dose, orally for up to 4 months
Other Name: Daxas, DalirespDrug: Pioglitazone
Other Name: Actos
Roflumilast dose and pioglitazone matching-placebo dose orally for up to 4 months.
Other Name: Daxas, DalirespDrug: Placebo
Pioglitazone placebo-matching dose
Pioglitazone dose, orally and roflumilast matching-placebo dose, orally for up to 4 months
Other Name: ActosDrug: Placebo
Roflumilast placebo-matching dose
This proof of concept study will evaluate the effect of roflumilast and pioglitazone on transaminase levels and liver fat content.
Takeda has chosen not to continue this Study, however, randomized subjects were allowed to complete the study per protocol.
The decision to terminate the study is not related to any safety concerns with either of the study medications.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01703260
|United States, California|
|Coronado, California, United States|
|Coronado, California, United States, 92118|
|United States, Maryland|
|Annapolis, Maryland, United States, 21401|
|Baltimore, Maryland, United States, 21202|
|Study Director:||Medical Director||Takeda Global Research and Development Center, Inc|