A PHASE I/IIa DOSE ESCALATION STUDY OF REPEATED ADMINISTRATION OF CYT107” (glyco-r-hIL-7) ADD ON TREATMENT IN GENOTYPE 1 or 4 HCV INFECTED PATIENTS RESISTANT TO PEGYLATED INTERFERON-ALPHA AND RIBAVIRI
- Conditions
- Hepatitis C, genotypes 1 and 4MedDRA version: 9.1Level: LLTClassification code 10008912Term: Chronic hepatitis C
- Registration Number
- EUCTR2007-007147-28-FR
- Lead Sponsor
- CYTHERIS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 36
1.Genotype 1 or 4 infected patients
2.Age > 18 years
3.Absence of viral response to previous treatments with pegylated interferon-alpha plus ribavirin defined as:
Absence of early viral response (EVR) with detectable HCV and with a decrease HCV RNA load < 2 logs, measured by a quantitative PCR tests after 12 weeks of treatment, as compared to baseline levels measured by a similar technique.
or
Absence of end of treatment response defined by detectable HCV RNA at the end of treatment (24 weeks or 48 weeks)
4.Multiples lines of previous treatment are allowed but must include at least one optimal line (pegylated IFN-a and ribavirin according to consensus as defined in Marketing Authorization)
Note: an optimal treatment is defined as full dose regimen of ribavirin and peg IFN, one step dose reduction is allowed: ribavirin dosage decreased to 600 mg or/and peg IFN decreased to 90 µg for pegasys or to 1µg/kg for viraferon
5.Metavir = F3 assessed by biopsy in the last 12 months or by fibroscan if Fibroscan® result < 10 kPa in the last 6 months (biopsy can be avoided)
6.Absence of lesion compatible with an HCC, checked within 6 months prior to study entry by ultrasound, CT-scan or MRI of the liver
7.Absolute Neutrophil Count > 1500 / mm3 (or WBC > 3000/mm3)
8.Platelets > 100,000/ mm3
9.Hemoglobin normal
10.PT/PTT normal at screening
11.Normal creatinine
12.Normal TSH at screening
13.Normal alkaline phosphatase and conjugated bilirubin at screening. Increase in non conjugated bilirubin is tolerate in Gilbert’s syndrome or evidence of hemolysis
14.Appropriate social insurance
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) yes
F.1.3.1 Number of subjects for this age range
1.Active infection by HBV (positive HBs Ag or positive anti HBc antibodies with a detectable HBV DNA viral load)
2.Infection by HIV-1 and /or HIV-2
3.Apart from HCV infection, presence of active infection requiring a specific treatment or a hospitalization
4.Other liver disease (notably from alcoholic, metabolic or immunological origin)
5.Body mass index (BMI) > 30kg/m2
6.ANA, SMA, anti LKM1, antithyroperoxydase or antimitochondrial antibodies with a titer > 1/80 in the 5 months preceding screening
7.Alpha-fetoprotein > 200 ng/mL or > 100 and < 200 with doubtful lesion documented by CAT-scan or MRI. in the 6 months preceding screening
8.ALT and/or AST > 5 x ULN (grade 2)
9.Relapse after previous response to pegylated IFN alpha and ribavirin therapy
10.Previous bitherapy with pegylated IFN alpha and ribavirin not well tolerated (ex: EPO, GCSF, treatment discontinuation) that could be predictive of a non sufficient tolerance for a new bitherapy and CYT107 administration, in the judgment of the investigator
11.Any history of malignancy apart from curatively treated basal cell carcinoma or in situ cervical carcinoma
12.Clinical signs of mixed cryoglobulinemia
13.History of clinical autoimmune disease or active auto-immune disease
14.History of severe asthma, presently on chronic medications
15.Iron deficiencies
16.Significant cardiac or pulmonary disease
17.QTc prolongation defined as a QTc greater than or equal to 470 ms or a prior history of cardiovascular disease, arrhythmias, or significant ECG abnormalities
18.Prior solid organ or hematopoietic cell transplantation
19.Dialyzed patient
20.Inability or refusal to practice an effective contraception until 6 months after the end of ribavirin treatment, in women of childbearing potential. Absence of protection until 6 months after the end of ribavirin treatment, in male patients or male partners of the patient.
21.Pregnancy or breastfeeding
22.History of medical or psychiatric disease which, in the view of the principal investigator, would preclude a good compliance
23.Current alcohol consumption
24.Current intravenous drug use
25.Concomitant treatment with anti-coagulant
26.Previous treatment with new antiviral drug under development (antipolymerase, antiprotease) at any time
27.Concomitant treatment or treatment within the previous 90 days prior to study entry by a drug known to have therapeutic activity in HCV infection or any immunomodulatory effect (apart from study drug), including systemic corticosteroids
28.Assessment of any other experimental therapy concomitantly or within the last 6 months.
29.Inability to give informed consent
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method