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

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2007-002139-94-FR
• Date of registration: 27/04/2007
• Prospective Registration: Yes
• Primary sponsor: Innate Pharma
• Public title: 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
• Scientific title: 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
• Date of first enrolment: 19/06/2007
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-002139-94
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: Association versus monotherapy

Countries of recruitment

France

Key inclusion & exclusion criteria

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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Non previously treated Hepatitis C patients
MedDRA version: 9.1 Level: LLT Classification code 10019744 Term: Hepatitis C

Intervention(s)

Product Name: Phosphostim 200
Product Code: IPH1101
Pharmaceutical Form: Powder for solution for infusion
CAS Number: 876060-87-6
Current Sponsor code: IPH1101
Other descriptive name: bromohydrin pyrophosphate (BrHPP)
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-

Trade Name: Proleukin 18MUI
Product Name: Proleukin 18 MUI
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: ALDESLEUKIN
CAS Number: 110942024
Concentration unit: million IU million international units
Concentration type: equal
Concentration number: 18-

Primary Outcome(s)

Main Objective: The primary objective is to assess the effect on viral load of IPH1101 administered in monotherapy or in association with a low dose of IL2 (2 MIU) in naïve hepatitis C patients.

Secondary Objective: Secondary objectives are to:
- Confirm the safety profile of the dose regimen in this population
- Assess the impact on viral load clearance kinetics (timing and duration of antiviral response) of IPH1101 alone or in association with a low dose of IL2
- Evaluate the biological activity: Gamma Delta T cells amplification, cytokines release, and soluble antiviral factors release (such as Serum neopterin, beta2 microglobulin) after IPH1101 in monotherapy or in association with IL2.

Primary end point(s): The primary endpoint will be the viral load. Serum HCV RNA will be evaluated by a standardized reverse-transcription PCR. Viral load will be assessed by quantitative HCV RNA detection. Efficacy for this exploratory proof of concept study will be defined by response corresponding to a diminution of ½ log in viral load from baseline on at least one blood sample over 12 weeks.

Secondary ID(s)

IPH1101-203