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)

Hoffmann-La Roche5 sites in 1 country22 target enrollmentApril 15, 2008

ConditionsNon-Alcoholic Steatohepatitis (NASH)

InterventionsTRO19622 Placebo

Overview

Phase: Phase 2
Intervention: TRO19622
Conditions: Non-Alcoholic Steatohepatitis (NASH)
Sponsor: Hoffmann-La Roche
Enrollment: 22
Locations: 5
Primary Endpoint: 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).
Status: Completed
Last Updated: 4 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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).

Registry

clinicaltrials.gov

Start Date

April 15, 2008

End Date

February 5, 2009

Last Updated

4 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Hoffmann-La Roche

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Adult subjects older than 18 years.
•Persistent ALT elevation (\> 2 times the ULN of the local laboratory of the investigating site) over 6 months prior to entry into study.
•No more than one ALT value within the normal range in the past year.
•Patients must have had an ALT measurement at least once every 6 months within the year before inclusion.
•Histologically confirmed diagnosis of steatohepatitis on biopsy within 2 years prior to entry into protocol.
•Compensated liver disease with the following hematologic, biochemical, and serological criteria on entry into protocol:
•Hemoglobin \> 11 gm/dL for females and \> 12 gm/dL for males
•White blood cell (WBC) \> 2.5 K/UL
•Neutrophil count \> 1.5 K/UL
•Platelets \> 100 K/UL

Exclusion Criteria

•Evidence of another form of liver disease.
•History of excess alcohol ingestion: daily alcohol consumption \>30 g/day (3 drinks per day) for males and \>20 g/day (2 drinks/day) for females.
•Unstable metabolic condition: Weight change \> +/- 10% in the previous year, diabetes with poor glycemic control (HbA1c \>9%),introduction of an antidiabetic or of an anti-obesity drug in the past 6 months prior to screening.
•History of gastrointestinal bypass surgery or ingestion of drugs known to produce hepatic steatosis including corticosteroids,high-dose estrogens, methotrexate, tetracycline or amiodarone in the previous 6 months.
•Significant systemic or major illnesses other than liver disease,including congestive heart failure, coronary artery disease, cerebrovascular disease, pulmonary disease, renal failure, organ transplantation, serious psychiatric disease,malignancy that, in the opinion of the investigator would preclude treatment with TRO19622 and/or adequate follow up.
•HIV infection.
•Active substance abuse, such as inhaled or injection drugs within the previous year.
•Pregnancy or inability to practice adequate contraception in women of child-bearing potential.
•Active malignancy except cutaneous basocellular carcinoma.
•Any other condition which, in the opinion of the investigator would impede competence or compliance or possibly hinder completion of the study.

Arms & Interventions

TRO19622

TRO19622 500 mg

Intervention: TRO19622

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

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).

Time Frame: Mean change in ALT at V1 (Day15) and V2 (Day 30)

Secondary Outcomes

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.(V1 (Day 15), V2 (Day 30) and V3 (Day 60))