Dose Escalation Study of IL-7 and Bi-therapy in HCV Patients Resistant After 12 Weeks of Bi-therapy (ECLIPSE 1)
- Registration Number
- NCT01025596
- Lead Sponsor
- Cytheris SA
- Brief Summary
This study will evaluate the safety of a new experimental drug, IL-7, in people with HCV infection resistant after 12 weeks of bi-therapy.
- Detailed Description
This is a Phase I inter-patient dose-escalation study assessing weekly doses of Interleukin-7 (CYT107) in adult patients infected by Genotype 1 Virus of Hepatitis C and resistant to standard treatment with Peg-Interferon and Ribavirin (biotherapy)after 12 weeks of this standard 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 a subcutaneous administration of CYT107 per week for a total of 4 administrations.
Groups of 3 to 6 patients will be entered at each dose level of CYT107. Four dose levels are planned.
Eligible patients will a cycle of four weekly injections at a defined dose level in addition to the bi-therapy. Standard bi-therapy will continue 4 weeks after CYT107 treatment discontinuation. The duration of study is approximately 11 weeks including screening period.
Participants have 1 hospitalization overnight and 8 clinic visits. The four administrations are sub-cutaneous and are given as a shot under the skin in the arm or abdomen or leg.
During the study visits the following may be done:
* Medical history, physical examination, blood tests every visit.
* Electrocardiogram (EKG)
* Chest x-ray study
* Liver/spleen imaging
* Blood sample collections at frequent intervals
* Urine tests several times during the study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
- Genotype I infected patients
- Age > 18 years
- Absence of early viral response to a first treatment with PEG-interferon-alpha plus ribavirin given for at least 12 weeks. Absence of early viral response (EVR) will be defined as detectable HCV with a decrease HCV RNA load < 2 logs, measured by a quantitative PCR tests, as compared to baseline levels measured by a similar technique
- Ongoing treatment by PEG-interferon-alpha plus ribavirin at study entry
Main
- 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
- Cirrhosis (Metavir F4) assessed by biopsy or FibroScan® or by liver biopsy within the last 6 months prior CYT107 treatment initiation. If assessed by Fibroscan® patients with a result > 10 KPa will be excluded
- Other liver disease (notably from alcoholic, metabolic or immunological origin)
- Body mass index (BMI) > 30kg/m2
- Inability to give informed consent
- Administration of growth factors (G-CSF, EPO) within the 12 weeks of the combination therapy
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 standard bi-therapy in patients with a chronic infection by a genotype 1 Hepatitis C Virus (HCV) not responding to this combination therapy 12 weeks after its initiation. 8 weeks after start of CYT107
- Secondary Outcome Measures
Name Time Method Pharmacokinetics and pharmacodynamics of CYT107 in this patients population. As primary potential anti-viral effect of CYT107 As primary immune specific response to HCV As primary
Trial Locations
- Locations (7)
University of Zurich
🇨🇭Zurich, Switzerland
San Raffaele Scientific Institute
🇮🇹Milano, Italy
Azienda Ospedaliero-Universitaria, Policlinico Sant'Orsola Malpighi
🇮🇹Bologna, Italy
Hopital Kremlin Bicêtre
🇫🇷Kremlin Bicêtre, France
Beaujon Hospital
🇫🇷Clichy, France
Hopital Jean Verdier
🇫🇷Bondy, France
Hopital Civil
🇫🇷Strasbourg, France