Dose Escalation Study of Interleukin-7 (IL-7) and Bitherapy in Asiatic HCV Patients Resistant to Bitherapy (ECLIPSE 3)
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I/IIa Dose Escalation Study in Asia of Repeated Administration of "CYT107" (Glyco-r-hIL-7) Added on Treatment in Genotype 1 HCV Infected Patients Resistant to Pegylated Interferon-alpha and Ribavirin|
- 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 [ Time Frame: 12 weeks after start of CYT107 ] [ Designated as safety issue: Yes ]
- Pharmacokinetics and pharmacodynamics of CYT107 in this patients population. [ Time Frame: At short and mid terms follow-ups ] [ Designated as safety issue: No ]
- potential anti-viral effect of CYT107 [ Time Frame: 4 weeks and 12 weeks after start of CYT107 ] [ Designated as safety issue: No ]
- long-term safety and viral load variations [ Time Frame: 24 and 48 weeks after the start of CYT107 ] [ Designated as safety issue: Yes ]
- immune specific response to HCV [ Time Frame: 8 and 12 weeks after start of CYT107 ] [ Designated as safety issue: No ]
|Study Start Date:||January 2009|
|Estimated Study Completion Date:||December 2012|
|Estimated Primary Completion Date:||November 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 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
|Kaohsiung Medical University Hospital|
|Kaohsiung, Taiwan, 807|
|Chi Mei Medical Center|
|Cathay General Hospital|
|Taipe, Taiwan, 10650|
|Chang Gung Memorial Hospital|
|Taipe, Taiwan, 33305|
|Study Chair:||Wang-Long Chuang, MD||Kaohsiung Medical University Hospital - Taiwan|