Multiple dose Phase II study of IPH1101 in monotherapy or associated with a low dose of IL2 (2MIU) in non previously treated hepatitis C patients

Conditions: on previously treated Hepatitis C patients
MedDRA version: 9.1Level: LLTClassification code 10019744Term: Hepatitis C

Registration Number: EUCTR2007-002139-94-FR

Lead Sponsor: Innate Pharma

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1. Signed informed consent prior to any protocol-specific procedures
2. Patient has hepatitis C genotype 1, 2, 3 or 4 diagnosed on the following criteria
a. Positive HCV antibody
b. Serum HCV RNA superior to >10 000 IU/ml
3. HCV treatment naïve.
4. At least one elevated ALT value since diagnosis of HCV infection
5. No or mild liver fibrosis (as estimated by biopsy or non-invasive means within the last 6 months)
6. Aged between 18 and 65 years
7. At screening, Body Mass Index (BMI) within the range of > 18 and < 32 kg/m² at screening visit
8. Adequate bone marrow, hepatic and renal function as follows:
a. White blood cells (WBC) = 4 x 109/L, neutrophils = 2.5 x 109/L, lymphocytes = 1000/µL
b. Platelets = 150 x 109/L,
c. Haemoglobin = 12 g/dL or 7.44 mmol/L,
d. Total bilirubin = 2 x upper limit normal (ULN) and transaminases (AST/SGOT, ALT/ SGPT) = 5 x ULN
e. GGT = 3 x ULN
f. Serum Creatinin = 2 x ULN
9. Negative serology for hepatitis B surface antigen and HIV antibody
10. QTc (Bazett’s correction) interval duration < 430 ms for men, < 450 ms for women
11. Subject affiliated to the French Social Security
12. Patients (male and female) who accept and are able to use recognised highly effective contraception methods (oral contraceptives, intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly, or surgically sterile) throughout the study and up to 12 months after last dose of study drug, if applicable.
Are the trial subjects under 18? no
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) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Patients who received any antiviral treatment within 6 months preceding the inclusion in the study
2. Patients having any organ transplantation and/or having received immunosuppressor treatment such as corticosteroids, cyclosporine and derivative within the last 30 days
3. Pregnant or lactating women
4. Any known hypersensitivity to one of the study treatments
5. Patients having any following abnormality:
a. Known auto immune disease: positive result on any anti-DNA, anti-tissue, anti-thyroglobulin, anti-microsome, anti-TSH receptor, anti-thyroperoxidase
b. Abnormality of free T4 or TSH assay
6. Current other active infection; serious concurrent, uncontrolled medical disorder such as diabetes, autoimmune disease
7. Cardiovascular disease:
a. Stage III or IV congestive heart failure (CHF) as determined by the New York Heart Association (NYHA) classification system for heart failure. Note: patients with NYHA stage I or II CHF may be included provided they do not have arrhythmia requiring treatment or fulfil any other exclusion criteria
b. Myocardial infarction within the previous 6 months, or
c. Symptomatic cardiac arrhythmia requiring treatment
8. Major surgery within the 4 weeks preceding screening
9. History of general anaesthesia within the previous 30 days before the request for randomisation
10. Concomitant treatment with bisphosphonates, methadone or buprenorphine within the 30 days preceding screening or planned during the study
11. Evidence of alcohol abuse (> 25 units per week) within 12 months prior to the request for randomisation or by a positive alcohol breath test or patients who have consumed alcohol within the 48 hours prior to the first dose of study medications, and/or are unwilling to abstain from these products while on study
12. Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
13. Evidence of current intravenous drug toxicomania