None listed
Conditions
Interventions
Product Code: TRO 19622
Pharmaceutical Form: Capsule*
CAS Number: 22033-87-0
Current Sponsor code: TRO19622
Other descriptive name: 4-Cholesten-3-one, oxime
Concentration unit: mg milligram(s)
Concent
Sponsors
TROPHOS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult subjects older than 18 years. 2. Persistent ALT elevation (> 2x the upper limit normal of the local laboratory of the investigating site , ie > 70 U/L for males and > 54 U/L for females at Salpétrière) over 6 months prior to entry into study. No more than one ALT value within the normal range in the past year. 3. Histologically confirmed diagnosis of steatohepatitis (Brunt et al. criteria - Am J Gastroenterol 1999;94(9)2467-74) on biopsy within 2 years prior to entry into protocol. 4. 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 • Total bilirubin 36 g/L • TP> 80% . • Serum creatinine within normal limits 5. No other cause of chronic liver disease (autoimmune, primary biliary cirrhosis, HBV, Wilson, a-1-antitrypsin deficit, hemochromatosis etc. . . ) 6. If applicable, have a stable diabetes, defined as HgbA1c =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Evidence of another form of liver disease. 2. 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. 3. Unstable metabolic condition: Weight change > ±10% in the previous year, diabetes with poor glycemic control (HgbA1c > 9%), introduction of an antidiabetic or of an anti-obesity drug in the past 6 months prior to screening. 4. 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. 5. 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. 6. HIV infection. 7. Active substance abuse, such as inhaled or injection drugs within the previous year. 8. Pregnancy or inability to practice adequate contraception in women of child-bearing potential. 9. Active malignancy except cutaneous basocellular carcinoma. 10. Any other condition which, in the opinion of the investigator would impede competence or compliance or possibly hinder completion of the study. 11. Body mass index (BMI) >40 kg/m2 (obesity Grade III). 12. Type 1 diabetes or Insulin-treated type 2 diabetes. 13. Hemostasis disorders or current treatment with anticoagulants. 14. History of, or current cardiac dysrhythmias and / or a history of cardiovascular disease, including myocardial infarction, except patients with only well controlled hypertension. 15. Participation in any other investigational drug or therapy study within the previous 3 months. 16. Be possibly dependent on the Investigator or the Sponsor (eg, including, but not limited to, affiliated employee). 17. Medications that could interfere with TRO19622 absorption
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Exploratory study Short term effect on liver enzymes of TRO19622 in patients with Non Alcoholic Steatohepatitis(NASH).;Secondary Objective: Safety;Primary end point(s): Mean change in ALT as assessed by an ANCOVA with the following covariates: treatment, gendre, subject and time and a non parametric test (Conver-Salsburg) | — |
Countries
France
Outcome results
None listed