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Sponsored by: |
Trophos |
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Information provided by: | Trophos |
ClinicalTrials.gov Identifier: | NCT00666016 |
The purpose of this study is to assess the safety, the tolerability and the short term effect on liver enzymes of TRO19622 500 mg for one month in patients with Non-Alcoholic Steatohepatitis (NASH).
Condition | Intervention | Phase |
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Non-Alcoholic Steatohepatitis (NASH) |
Drug: TRO19622 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Double-Blind vs Placebo, Randomized, Exploratory Study to Assess the Short Term Effect on Liver Enzymes and the Safety of TRO19622 500 mg QD for One Month in Patients With Non-Alcoholic Steatohepatitis (NASH) |
Estimated Enrollment: | 30 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | November 2008 |
Estimated Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
TRO19622 500 mg
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Drug: TRO19622
TRO19622 500 mg once a day before noon meal during 6 weeks
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Persistent ALT elevation (> 2 times the ULN of the local laboratory of the investigating site) over 6 months prior to entry into study.
Compensated liver disease with the following hematologic, biochemical, and serological criteria on entry into protocol:
Exclusion Criteria:
France | |
Groupe Hospitalier Pitié-Salpétrière - Sce Hépato-Gastroentérologie - 47-83 Bd de l'Hôpital | Recruiting |
Paris, France, 75651 | |
Contact: Vlad Ratziu, MD 33-1-4216-1035 vratziu@teaser.fr | |
Principal Investigator: Vlad Ratziu, MD | |
Sub-Investigator: Joseph MOUSSALLI, MD | |
Sub-Investigator: Pascal LEBRAY, MD | |
Hôpital Archet 2 - Pôle de Référence Hépatite C (Niveau -2) - 151, route Saint Antoine de Ginestière | Not yet recruiting |
Nice, France, 06200 | |
Contact: Albert Tran, MD 33-4-9203-5943 Albert.TRAN@unice.fr | |
Principal Investigator: Albert Tran, MD | |
Sub-Investigator: Régine TRUCHI, MD | |
Sub-Investigator: Rodolphe Anty, MD |
Principal Investigator: | Vlad Ratziu, MD | GH PITIE-SALPETRIERE |
Responsible Party: | Trophos ( Nathalie Strub Wourgaft ) |
Study ID Numbers: | TRO19622 CL E Q 1159-1 |
Study First Received: | April 22, 2008 |
Last Updated: | April 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00666016 History of Changes |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
non alcoholic steatohepatitis nash hepatoprotective hepatoprotection ALT AST new drug candidate interventional study TRO19622 Trophos cholest-4-en-3-one
oxime |
Liver Diseases Non-alcoholic Steatohepatitis (NASH) Digestive System Diseases Fatty Liver |
Liver Diseases Digestive System Diseases Fatty Liver |