| Trial ID: | L0180 |
| Source ID: | NCT00666016
|
| Associated Drug: |
TRO19622
|
| Title: |
Exploratory Study to Assess the Short Term Effect on Liver Enzymes and the Safety of TRO19622 in Patients With Non-Alcoholic Steatohepatitis (NASH)
|
| Acronym: |
--
|
| Status: |
Completed
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Non-Alcoholic Steatohepatitis (NASH)
|
| Interventions: |
Drug: TRO19622
|
| Outcome Measures: |
Mean change in ALT as assessed by an ANCOVA with the following covariates: treatment, gender, subject and time and a non parametric test (Conover-Salsburg).|Sustained reduction in ALT to either 50% of baseline or value < or equal to ULN. Sustained reduction serum AST and GGT.Clinical and laboratory safety.
|
| Sponsor/Collaborators: |
Hoffmann-La Roche
|
| Gender: |
All
|
| Age: |
18 Years and older ?? (Adult, Older Adult)
|
| Phases: |
Phase 2
|
| Enrollment: |
35
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
|
| Start Date: |
April 2008
|
| Completion Date: |
April 2009
|
| Results First Posted: |
--
|
| Last Update Posted: |
November 22, 2016
|
| Locations: |
H??pital Archet 2 - P??le de R??f??rence H??patite C (Niveau -2) - 151, route Saint Antoine de Ginesti??re, Nice, France|Groupe Hospitalier Piti??-Salp??tri??re - Sce H??pato-Gastroent??rologie - 47-83 Bd de l'H??pital, Paris, France
|
| URL: |
https://ClinicalTrials.gov/show/NCT00666016
|
