Hepatitis C
Conditions
Keywords
interleukin-7, immune-based therapies, hepatitis C, chronic hepatitis, resistance to Peg-interferon and ribavirin bitherapy, immune specific responses to HCV, taiwan, phase 1/2a, viral disease, liver disease
Brief summary
This study is designed to evaluate the safety of biological active dose of a new experimental drug, IL-7, in combination with standard bi-therapy in Asiatic patients with Hepatitis C chronic infection identified as non responders to the standard bi-therapy alone.
Detailed description
This is a Phase I/IIa inter-patient dose-escalation study assessing weekly doses of Interleukin-7 (CYT107) in Asiatic adult patients infected by virus of genotype 1 of Hepatitis C and resistant to standard treatment with Peg-Interferon and Ribavirin (bi-therapy). The dose escalation is aimed at establishing the safety of a biologically active doses of CYT107 added to the combination therapy of pegylated interferon-alpha and ribavirin. At each dose level, study patients will receive one subcutaneous administration of CYT107 per week for a total of 4. Groups of 3 to 6 patients will be entered at each dose level of CYT107. Three dose levels are planned. Eligible patients initially receive bi-therapy for 6-10 weeks. Thereafter, CYT107 is added for a cycle of four weekly injections at a defined dose level while standard bi-therapy continues for 9 weeks after CYT107 treatment discontinuation. The patients are then followed on a regular basis until reaching 48 weeks after the CYT107 treatment. The duration of study is approximatively 60 weeks with 20-25 weeks of bi-therapy. Participants will have 1 overnight hospitalization and 15 clinic visit on a period of 60 weeks. During the visits the following may be done: * medical history, physical examination, blood tests * electrocardiograms (ECG) * chest X-Ray * liver/spleen imaging * urine tests
Interventions
DRUGInterleukin-7
3 dose levels: 3, 10 & 20 µg/kg. 4 administrations, 1 per week
Sponsors
Cytheris SA
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Main Inclusion Criteria: * HCV Genotype 1 infected patients * Absence of viral response to previous treatments with pegylated interferon-alpha plus ribavirin * Metavir ≤ F3 assessed by biopsy in the last 12 months Main
Exclusion criteria
* Active infection by HBV * Infection by HIV-1 and /or HIV-2 * Apart from HCV infection, presence of active infection requiring a specific treatment or a hospitalization * Other liver disease * Body mass index (BMI) \> 30kg/m2 * Relapse after previous response to pegylated IFN alpha and ribavirin therapy * Previous bi-therapy with pegylated IFN alpha and ribavirin not well tolerated (in particular treatment discontinuation) * Any history of malignancy apart from curatively treated basal cell carcinoma or in situ cervical carcinoma * History of clinical autoimmune disease or active auto-immune disease * History of severe asthma, presently on chronic medications * Significant cardiac or pulmonary disease * Inability to give informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety of biologically active doses of CYT107 added to a combination therapy by pegylated interferon-alpha and ribavirin in Asian patients with a chronic infection by a genotype 1 HCV not responding to this combination therapy | 12 weeks after start of CYT107 |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics and pharmacodynamics of CYT107 in this patients population. | At short and mid terms follow-ups |
| potential anti-viral effect of CYT107 | 4 weeks and 12 weeks after start of CYT107 |
| long-term safety and viral load variations | 24 and 48 weeks after the start of CYT107 |
| immune specific response to HCV | 8 and 12 weeks after start of CYT107 |
Countries
Taiwan
Outcome results
None listed