| Trial ID: | L0139 |
| Source ID: | NCT03639623
|
| Associated Drug: |
Saroglitazar
|
| Title: |
Safety, Tolerability and Efficacy of Saroglitazar Mg 4 mg in Liver Transplant Recipients With NAFLD
|
| Acronym: |
--
|
| Status: |
Recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Liver Transplant; Complications|NAFLD
|
| Interventions: |
Drug: Saroglitazar
|
| Outcome Measures: |
Number of participants with adverse events assessed by CTCAE|Hepatic fat|Metabolic flexibility|Frequently sampled intravenous glucose tolerance test (Insulin resistance marker)|Glycosylated hemoglobin (Insulin resistance marker)|Fructosamine (Insulin resistance marker)|Serum liver enzymes|Serum lipids|Small dense low-density lipoprotein (Atherogenic lipoprotein)|LDL size and concentration (Atherogenic lipoprotein)|Very low-density lipoprotein (Atherogenic lipoprotein)|High-density lipoprotein (Atherogenic lipoprotein)|Quality of life (SF-36 Health Survey)|Peak plasma concentration [Cmax]|Time to reach peak plasma concentration [Tmax]|Area under plasma concentration vs. time curve till the last time point [AUC0-t]|Area under plasma concentration vs. time curve extrapolated to the infinity [AUC0-???] after first dose|Area under plasma concentration vs. time curve in a 24 h dosing interval [AUCtau]|Elimination rate constant [??z]|Elimination half-life [t1/2]|Apparent volume of distribution [Vd/F]|Apparent clearance [CL/F]|Minimal or trough plasma concentration [Cmin] -for last dose only|Accumulation index calculated as a ratio of AUCtau (last dose)/AUCtau (first dose)|Fluctuation index
|
| Sponsor/Collaborators: |
Zydus Therapeutics Inc.
|
| Gender: |
All
|
| Age: |
18 Years to 75 Years ?? (Adult, Older Adult)
|
| Phases: |
Phase 2
|
| Enrollment: |
15
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
|
| Start Date: |
February 25, 2019
|
| Completion Date: |
June 2022
|
| Results First Posted: |
--
|
| Last Update Posted: |
January 5, 2022
|
| Locations: |
Virginia Commonwealth University, Richmond, Virginia, United States
|
| URL: |
https://ClinicalTrials.gov/show/NCT03639623
|
