Chronic Hepatitis C
Conditions
Interventions
Product Name: FTY720
Product Code: FTY720
Pharmaceutical Form: Capsule*
INN or Proposed INN: FTY720
Current Sponsor code: FTY720
Concentration unit: mg milligram(s)
Concentration type: equal
Concentra
Sponsors
Novartis Farmaceutica S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patient must be diagnosed with chronic Hepatitis C, with histological evidence of liver fibrosis scored (Fibrosis scale of Knodell/META VIR/ Batts-Ludwig scoring system) on recent liver biopsy performed within the 36 months preceding Screening as either; Stage F1, F2 pr F3 or Stage F0 fibrosis with an inflammatory grade greater than 1. • Patients must have been non-responsive to, as judged by HCV viral response, or have had documented intolerance of, any Interferon-based therapy at standard dosing regimens. An HCV viral response is defined as a drop in viral load of at least 2 log10 or to undetectable levels after at least 12 weeks of standard therapy. • Patients should have elevated ALT levels, between 1.3 x and 10 x ULN. • Male and female patients aged 18 to 60 years (inclusive). • Females capable of becoming pregnant must have a negative pregnancy test at screening and Week 4, prior to first administration of FTY720 and are required to practice a double barrier method of contraception (diaphragm with spermicide, diaphragm with condom worn by the male partner or condom plus spermicide) throughout the treatment period and for three months thereafter. • Patients who are willing and able to participate in the full course of the study and from whom written informed consent to participate in the study has been obtained. Are the trial subjects under 18? Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Patients with advanced liver fibrosis (F4, cirrhosis) on pre-existing historical biopsy. • Patients with BMI >30. • Patients likely to consume alcohol during the study. • Patients suffering from relapses of viral load, following interferon-based treatment. • Patients with a past or present malignancy, except for successfully treated basal or squamous cell carcinoma excised at least two years prior to screening. • Patients who are taking, or have taken, any other immunomodulatory medication including but not limited to Interferons, Interleukin-10, Interleukin-12, cyclophosphamide, azathioprine, methotrexate, mitoxantrone, linomide, cyclosporine, corticosteroids, deoxyspergualine or antibody-based therapies within 4 weeks prior to enrollment. • Patients with a pulse rate < 55 beats per minute (bpm) at baseline after 3 minutes resting in a supine position. • Patients with any medical or psychosocial condition, which the investigator believes, would hinder compliance with the study requirements, including a history of drug or alcohol abuse in the past 6 months. • Patients who are Human Immunodeficiency Virus (HIV) positive or hepatitis B surface antigen positive.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To examine the effect of 24 weeks of FTY720 treatment on chronic Hepatitis C, as measured by HCV viral load.;Secondary Objective: To explore the impact of FTY720 treatment on change of inflammatory grade and fibrosis stage on liver histology To explore the impact of FTY720 treatment on Hepatic enzyme levels. To explore the impact of FTY720 treatment on the inflammatory (Acti-Test) and fibrosis (Fibro-Test) components of FibrosureTM, a serum-based test for liver inflammation and fibrosis. To explore the agreement between the inflammatory (Acti-Test) and fibrosis (Fibro-Test) components of FibrosureTM, and corresponding histological parameters from liver biopsy. To explore the agreement between changes in inflammatory (Acti-Test) and fibrosis (Fibro-Test)components of FibrosureTM and changes corresponding histological paramenters from liver biopsy associated with the use of FTY720;Primary end point(s): The change in serum Hepatitis C viral load will be utilized as the primary (safety) assessment of this study. Liver biopsy will be carried out on Day 1 during the baseline period and at the end of treatment period (Week 28, visti 11) to assess the effect on FTY720 on liver inflammation. It is hypothesized that the pharmacodynamic action of FTY720, to sequester lymphocytes away from the liver, may result in reduced inflammation. Furthermore, FibrosureTM, a serum marker assay of liver fibrosis and inflammation, will be used as an exploratory efficacy assessment at the start of treatment (Week 4) , during treatment (week 12) and at the end of treatment (Week 28) | — |
Countries
Spain
Outcome results
None listed