Dose Escalation Study of Interleukin-7 (IL-7) and Bitherapy in Asiatic HCV Patients Resistant to Bitherapy
- Registration Number
- NCT01024894
- Lead Sponsor
- Cytheris SA
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 15
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description CYT107 Interleukin-7 -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (4)
Kaohsiung Medical University Hospital
🇨🇳Kaohsiung, Taiwan
Chi Mei Medical Center
🇨🇳Tainan, Taiwan
Cathay General Hospital
🇨🇳Taipe, Taiwan
Chang Gung Memorial Hospital
🇨🇳Taipe, Taiwan