Dose Escalation Study of Interleukin-7 (IL-7) and Bitherapy in HCV Genotype 1 or 4 Patients Resistant to Bitherapy Alone (Eclipse 2)
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 patients with Hepatitis C chronic infection identified as non responders to the standard bi-therapy alone.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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 Ribavirin|
- To evaluate at W 12 the safety of biologically active doses of CYT107 added to a combination therapy by pegylated interferon-alpha and ribavirin [ Time Frame: 12 weeks after the start of IL-7 ] [ Designated as safety issue: Yes ]
- To characterize pharmacokinetics and pharmacodynamics of CYT107 [ Time Frame: 12 weeks after the start of IL-7 ] [ Designated as safety issue: No ]
- To evaluate in the context of a dose escalation strategy the potential anti-viral effect of CYT107 [ Time Frame: 12 weeks after the start of IL-7 ] [ Designated as safety issue: No ]
- To evaluate the immune specific response to HCV [ Time Frame: 12 weeks after the start of IL-7 ] [ Designated as safety issue: No ]
- To document the long-term safety and viral load variations [ Time Frame: 48 weeks after the start of IL-7 ] [ Designated as safety issue: Yes ]
|Study Start Date:||July 2008|
|Estimated Study Completion Date:||March 2013|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
3 dose levels: 3, 10 & 20 µg/kg. 4 administrations, 1 per week
This is a Phase I/IIa inter-patient dose-escalation study assessing weekly doses of Interleukin-7 (CYT107) in adult patients infected by virus genotype 1 or 4 of Hepatitis C and resistant to standard treatment with Peg-Interferon and Ribavirin (bitherapy).
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 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
|Hopital Jean Verdier|
|Hopital Kremlin Bicêtre|
|Kremlin Bicêtre, France|
|Azienda Ospedaliero-Universitaria, Policlinico Sant'Orsola Malpighi|
|San Raffaele Scientific Institute|
|Fatebenefratelli e Oftalmico|
|University of Zurich|
|Study Chair:||Tilman Gerlach||Hospital of San Gallen-Switzerland|